ID

39272

Description

Study ID: 110771 Clinical Study ID: 110771 Study Title: An open label positron emission tomography (PET) study to investigate brain penetration by [carbonyl-11C] GSK1034702 in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Positron Emission Tomography Trade Name: Carbonyl-11C Study Indication: Cognitive Disorders, Alzheimer's disease, schizophrenia.

Keywords

  1. 12/15/19 12/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 15, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Brain Penetration by [Carbonyl-11C] GSK1034702; 110771

Screening

  1. StudyEvent: ODM
    1. Screening
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Patient date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnic group

Data type

text

Alias
UMLS CUI [1]
C0015031
Geographic Ancestry
Description

Your ancestry or national origin

Data type

text

Alias
UMLS CUI [1]
C3841890
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Height
Description

Body Height

Data type

integer

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

Body Weight

Data type

float

Measurement units
  • kg/m2
Alias
UMLS CUI [1]
C0005910
kg/m2
Body mass index
Description

Body mass index

Data type

float

Measurement units
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Date
Description

Vital Signs Date

Data type

date

Alias
UMLS CUI [1]
C2826644
Planned Relative Time
Description

Vital signs, Relative time, Planned

Data type

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Actual Time
Description

Vital Signs Time

Data type

time

Alias
UMLS CUI [1]
C2826762
Blood Pressure - Systolic
Description

Systolic Pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Blood Pressure - Diastolic
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Subject Position
Description

Vital signs, Body position

Data type

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1262869
Heart Rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Medical Conditions
Description

Medical Conditions

Alias
UMLS CUI-1
C0012634
Diagnosis
Description

Disease, Diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0011900
Current or Past?
Description

Disease, Current or past

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1444635
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Date of Assessment
Description

Physical Examination, Assessment Date

Data type

date

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C2985720
Physical Examination
Description

Physical Examination, body system or organ function

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0678852
Result
Description

Physical Examination, Test Result

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0456984
Comment
Description

Physical Examination, Comment

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0947611
Allen's Test
Description

Allen's Test

Alias
UMLS CUI-1
C0231664
Was an Allen's Test performed?
Description

Allen test

Data type

boolean

Alias
UMLS CUI [1]
C0231664
Alcohol Intake
Description

Alcohol Intake

Alias
UMLS CUI-1
C0001948
Does the subject consume alcohol?
Description

Alcohol consumption

Data type

boolean

Alias
UMLS CUI [1]
C0001948
If Yes, record the average number of units of alcohol consumed per week
Description

Alcohol consumption, alcohol units/week

Data type

integer

Measurement units
  • units per week
Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
units per week
Drug and Alcohol Screen
Description

Drug and Alcohol Screen

Alias
UMLS CUI-1
C0202274
UMLS CUI-2
C0202304
Date and time of sample taken
Description

Urine drug screening, Ethanol measurement, Sampling, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0202304
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Cocaine
Description

Urine drug screening, Cocaine

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0009170
Amphetamines
Description

Urine drug screening, Amphetamines

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0002667
Benzodiazepines
Description

Urine drug screening, Benzodiazepines

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0005064
Cannabinoids
Description

Urine drug screening, Cannabis

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0936079
Opiates
Description

Urine drug screening, Opiates

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0376196
Barbiturates
Description

Urine drug screening, Barbiturates

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0004745
Cotinine
Description

Urine drug screening, Cotinine measurement

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0202363
Alcohol
Description

Ethanol measurement

Data type

text

Alias
UMLS CUI [1]
C0202304
Smokerlyser Breath Test
Description

Smokerlyser Breath Test

Alias
UMLS CUI-1
C2207180
Date sample taken
Description

breath test expired carbon monoxide, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C2207180
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Results
Description

breath test expired carbon monoxide, Result

Data type

text

Alias
UMLS CUI [1,1]
C2207180
UMLS CUI [1,2]
C1274040
Serology
Description

Serology

Alias
UMLS CUI-1
C0036743
Date sample taken
Description

Serologic tests, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
HIV antibody
Description

Serologic tests, HIV Screen

Data type

text

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0459958
Hepatitis B surface antigen
Description

Serologic tests, Hepatitis B Surface Antigens

Data type

text

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0019168
Hepatitis C antibody
Description

Serologic tests, Hepatitis C antibody measurement

Data type

text

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0201487
M.I.N.I
Description

M.I.N.I

Alias
UMLS CUI-1
C4505426
Has the M.I.N.I. assessment been performed?
Description

Mini International Neuropsychiatric Interview

Data type

boolean

Alias
UMLS CUI [1]
C4505426
Electronically Transferred Laboratory Data (Haematology)
Description

Electronically Transferred Laboratory Data (Haematology)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Date Sample Taken
Description

Laboratory Procedures, Hematology finding, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Description

Laboratory Procedures, Hematology finding, Sampling, Time

Data type

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
Electronically Transferred Laboratory Data (Clinical Chemistry)
Description

Electronically Transferred Laboratory Data (Clinical Chemistry)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Date Sample Taken
Description

Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Description

Laboratory Procedures, Chemistry, Clinical, Sampling, Time

Data type

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
Urinalysis
Description

Urinalysis

Alias
UMLS CUI-1
C0042014
Date Sample Taken
Description

Urinalysis, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Description

Urinalysis, Sampling, Time

Data type

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0040223
Electronically Transferred Laboratory Data (Renal Blood Monitoring)
Description

Electronically Transferred Laboratory Data (Renal Blood Monitoring)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0232804
UMLS CUI-3
C0005767
Date Sample Taken
Description

Laboratory Procedures, Renal function, Blood, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0232804
UMLS CUI [1,3]
C0005767
UMLS CUI [1,4]
C0870078
UMLS CUI [1,5]
C0011008
Actual Time
Description

Laboratory Procedures, Renal function, Blood, Sampling, Time

Data type

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0232804
UMLS CUI [1,3]
C0005767
UMLS CUI [1,4]
C0870078
UMLS CUI [1,5]
C0040223
Electronically Transferred Laboratory Data (Renal Urine Monitoring)
Description

Electronically Transferred Laboratory Data (Renal Urine Monitoring)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0232804
UMLS CUI-3
C0042036
Date Sample Taken
Description

Laboratory Procedures, Renal function, Urine, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0232804
UMLS CUI [1,3]
C0042036
UMLS CUI [1,4]
C0870078
UMLS CUI [1,5]
C0011008
Actual Time
Description

Laboratory Procedures, Renal function, Urine, Sampling, Time

Data type

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0232804
UMLS CUI [1,3]
C0042036
UMLS CUI [1,4]
C0870078
UMLS CUI [1,5]
C0040223
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
ECG Number
Description

12 lead ECG, Numbers

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0237753
Start Date of ECG
Description

12 lead ECG, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Planned Relative Time
Description

12 lead ECG, Relative time, Planned

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Start Time of ECG
Description

12 lead ECG, Start time

Data type

time

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

12 lead ECG, Heart rate

Data type

integer

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

12 lead ECG, PR interval

Data type

integer

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

12 lead ECG, QRS complex duration

Data type

integer

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

12 lead ECG, QT interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Description

12 lead ECG, Electrocardiogram QT corrected interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
Result of the ECG
Description

12 lead ECG, Result

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
Summary Holter
Description

Summary Holter

Alias
UMLS CUI-1
C0013801
Start Date of Holter
Description

Holter Electrocardiography, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
Start time of Holter
Description

Holter Electrocardiography, Start time

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1301880
Stop date of Holter
Description

Holter Electrocardiography, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
Stop time of Holter
Description

Holter Electrocardiography, End time

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1522314
Interpretation of Holter
Description

Holter Electrocardiography, Clinical Interpretation

Data type

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C4086187
Holter monitoring method
Description

Holter Electrocardiography, Test Method

Data type

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0871511
Eligibility Question
Description

Eligibility Question

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Description

Eligibility Determination

Data type

boolean

Alias
UMLS CUI [1]
C0013893
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Healthy as determined by a reasonable and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with renal monitoring test values outside of the ranges in Appendix 2 (of the protocol) should always be excluded from enrolment.
Description

Health status

Data type

boolean

Alias
UMLS CUI [1]
C0018759
Male subject between 35 and 55 years of age inclusive, at the time of signing the informed consent.
Description

Gender; Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
Male subjects must agree to use one of the contraception methods listed in Section 8.1 (of the protocol). This criterion must be followed from the time the first administration of [11C]GSK1034702 until completion of the study and for 4 months after dosing.
Description

Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Body weight >= 50kg and BMI within the range 19.0 - 29.0 kg/m2 (inclusive).
Description

Body Weight; Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Adequate collateral flow to the radial and ulnar arteries in both hands as determined by the Allen's test.
Description

Allen test, Negative finding

Data type

boolean

Alias
UMLS CUI [1,1]
C0231664
UMLS CUI [1,2]
C1513916
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
A positive pre-study drug/alcohol screen. A minimum list of drug that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
Description

Drug screen; Ethanol measurement

Data type

boolean

Alias
UMLS CUI [1]
C0373483
UMLS CUI [2]
C0202304
Urinary cotinine levels indicate of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
Description

Urine cotinine measurement, Tobacco use

Data type

boolean

Alias
UMLS CUI [1,1]
C1278256
UMLS CUI [1,2]
C0543414
History of alcohol consumption within 6 months of the study defined as: - An average weekly intake of > 21 Units for males or > 14 units for females. One unit is equivalent to 8g of alcohol: a half-pint (240mL) of beer, 1 glass (125mL) of wine or 1 (25 mL) measure of spirits.
Description

Alcohol consumption

Data type

boolean

Alias
UMLS CUI [1]
C0001948
A positive pre-study Hepatitis B surface antigen (HBsAg) or positive Hepatitis C antibody result within 3 months of screening.
Description

Hepatitis B surface antigen positive; Hepatitis C antibody positive

Data type

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
A positive test for human immunodeficiency virus (HIV) antibody.
Description

HIV antibody positive

Data type

boolean

Alias
UMLS CUI [1]
C0920548
A screening ECG with a QTc value of >450msec (triplicate ECGs) and/or a PR interval outside the range 120 to 200msec (triplicate ECGs) or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T-wave)
Description

Electrocardiogram, Abnormality

Data type

boolean

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C1704258
Puls rate <50 or >90 BPM OR a systolic BP > 140 or <90 OR a diastolic BP >90 0r <60 OR orthostatic hypotension (reduction of systolic BP >10mmHg).
Description

Heart rate; Systolic Pressure; Diastolic blood pressure; Hypotension, Orthostatic

Data type

boolean

Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4]
C0020651
History of long QT syndrome (personal or family) or other cardiac conduction disorder, a history of sudden unexplained death or unexplained syncope in a first degree relative or other clinically significant cardiac disease.
Description

Long QT Syndrome; Cardiac conduction abnormality; Sudden death, Unexplained; Syncope, Unexplained; Heart Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0023976
UMLS CUI [2]
C1842820
UMLS CUI [3,1]
C0011071
UMLS CUI [3,2]
C4288071
UMLS CUI [4,1]
C0039070
UMLS CUI [4,2]
C4288071
UMLS CUI [5]
C0018799
Subjects with current or past disease of cardiovascular disease including but not limited to hypertension, cardiac arrhythmias and/or risk factors for coronary artery disease.
Description

Cardiovascular Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0007222
Current or recent (without one year) gastrointestinal disease; a history of malabsorption, oesophageal reflux, irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecystectomy) which would be expected to influence the absorption of drugs.
Description

Gastrointestinal Diseases; Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0543467
Subjects who have current respiratory or a history of respiratory problems (e.g. asthma or allergies, including childhood conditions).
Description

Respiration Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0035204
Subjects who have current renal or history of clinically significant renal abnormalities.
Description

Renal function, Abnormality

Data type

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C1704258
History or presence of a neurological diagnosis (not limited to but including for example, stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, schizophrenia, major depression etc) that may influence the outcome or analysis of the scan results.
Description

nervous system disorder

Data type

boolean

Alias
UMLS CUI [1]
C0027765
Any previous or current psychiatric history, as assessed by the M.I.N.I
Description

Psychiatric History

Data type

boolean

Alias
UMLS CUI [1]
C0748059
Any history of suicidal behavior or an suicidal ideation of type 4 or 5 on the CSSRS in the last month.
Description

Suicidal behavior; Active suicidal ideation

Data type

boolean

Alias
UMLS CUI [1]
C3641604
UMLS CUI [2]
C0749133
Subject is mentally or legally incapacitated.
Description

Mental handicap; legal capacity, Lacking

Data type

boolean

Alias
UMLS CUI [1]
C1306341
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0332268
Use of prescription or non-prescription drugs, including vitamins, herbal or dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
Description

Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1]
C0013227
Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
Description

Red wine, Citrus aurantium, Grapefruit, Grapefruit juice

Data type

boolean

Alias
UMLS CUI [1]
C0349371
UMLS CUI [2]
C0330922
UMLS CUI [3]
C0995150
UMLS CUI [4]
C0452456
Where participation in the study would result in donation of blood or blood products in excess of 500mL within a 56 day period
Description

Blood Donation

Data type

boolean

Alias
UMLS CUI [1]
C0005794
History of sensitivity to any of the study medications, or components thereof or a history or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
Description

Experimental drug, Hypersensitivity; Hypersensitivity, Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0020517
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0205394
The subject has participated in a clinical trial and has received an IP within the following time period prior to the fist dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the IP (whichever is longer).
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Exposure to more than three new chemical entities within 12 months prior to the first dosing day.
Description

Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1]
C0013227
Unwillingness or inability to follow the procedures outlined in the protocol.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden (a significant radiation burden being defined as >10mSv in addition to natural background in the previous 3 years). Or worked as a welder , metal worker or machinist.
Description

Extensive Radiation

Data type

boolean

Alias
UMLS CUI [1]
C1517030
History of, or suffers from, claustrophobia or feels that he will be unable to lie still on his back in the PET or MRI scanner for a period of 1-2 h.
Description

Claustrophobia; Magnetic Resonance Imaging, Unable; Positron emission tomography unit, Unable

Data type

boolean

Alias
UMLS CUI [1]
C0008909
UMLS CUI [2,1]
C0024485
UMLS CUI [2,2]
C1299582
UMLS CUI [3,1]
C0182349
UMLS CUI [3,2]
C1299582
Presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies as assessed by a standard pre-MRI questionnaire
Description

Artificial cardiac pacemaker; presence of metallic device / implant

Data type

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C3693688
12-Lead ECG Abnormalities
Description

12-Lead ECG Abnormalities

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1704258
ECG Number
Description

12 lead ECG, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0237753
Date of ECG
Description

12 lead ECG, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
Time of ECG
Description

12 lead ECG, Time

Data type

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0040223
Rhythm
Description

12 lead ECG, Abnormality, Rhythm

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0199556
Comment
Description

12 lead ECG, Abnormality, Rhythm

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0199556
P-Wave and QRS Morphology
Description

12 lead ECG, Abnormality, electrocardiogram: P wave shifting morphology; Electrocardiogram QRS complex

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2216025
UMLS CUI [1,4]
C0429098
Comment
Description

12 lead ECG, Abnormality, electrocardiogram: P wave shifting morphology; Electrocardiogram QRS complex

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2216025
UMLS CUI [1,4]
C0429098
Conduction
Description

12 lead ECG, Abnormality, Cardiac Conduction

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0232217
Comment
Description

12 lead ECG, Abnormality, Cardiac Conduction

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0232217
Myocardial Infarction
Description

12 lead ECG, Abnormality, Myocardial Infarction

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0027051
Comment
Description

12 lead ECG, Abnormality, Myocardial Infarction

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0027051
Depolarisation/Repolarisation (QRS-T)
Description

12 lead ECG, Abnormality, Ventricular Depolarization [PE], Electrocardiogram repolarisation abnormality

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C1331539
UMLS CUI [1,4]
C0948857
Comment
Description

12 lead ECG, Abnormality, Ventricular Depolarization [PE], Electrocardiogram repolarisation abnormality

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C1331539
UMLS CUI [1,4]
C0948857
Other Abnormalities
Description

12 lead ECG, Abnormality, Other

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0205394
Comment
Description

12 lead ECG, Abnormality, Other

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0205394
Summary Holter Abnormalities
Description

Summary Holter Abnormalities

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C1704258
Start Date of Holter
Description

Holter Electrocardiography, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
Stop Date of Holter
Description

Holter Electrocardiography, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
Start Time of Holter
Description

Holter Electrocardiography, Start Time

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1301880
Stop Time of Holter
Description

Holter Electrocardiography, End Time

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1522314
Record clinically significant abnormalities below
Description

Holter Electrocardiography, Abnormality

Data type

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1704258
Other abnormal rhythm, Comment
Description

Holter Eletrocardiography, Abnormality, Electrocardiogram, rhythm

Data type

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0199556
Other morphology, Comment
Description

Holter Eletrocardiography, Abnormality, electrocardiogram: P wave shifting morphology, Electrocardiogram QRS complex

Data type

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2216025
UMLS CUI [1,4]
C0429098
Other conduction, Comment
Description

Holter Eletrocardiography, Abnormality, Cardiac conduction

Data type

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0232217
Other depolarisation/repolarization, Comment
Description

Holter Eletrocardiography, Abnormality, Ventricular Depolarization, Electrocardiogram repolarisation abnormality

Data type

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C1331539
UMLS CUI [1,4]
C0948857
Other abnormality/Cardiologist comments
Description

Holter Eletrocardiography, Abnormality, Other, Comment

Data type

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0947611

Similar models

Screening

  1. StudyEvent: ODM
    1. Screening
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Item
Ethnicity
text
C0015031 (UMLS CUI [1])
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Geographic Ancestry
text
C3841890 (UMLS CUI [1])
Code List
Geographic Ancestry
CL Item
African American/African Heritage  (1)
CL Item
American Indian or Alaskan Native  (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage  (6)
CL Item
Native Hawaiian or Other Pacific Islander  (7)
CL Item
White - Arabic/North African Heritage  (8)
CL Item
White - White/Caucasian/European Heritage (9)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Vital Signs Date
Item
Date
date
C2826644 (UMLS CUI [1])
Item
Planned Relative Time
text
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Code List
Planned Relative Time
CL Item
Screening (1)
CL Item
Screening (2)
CL Item
Unscheduled (3)
CL Item
Unscheduled (4)
Vital Signs Time
Item
Actual Time
time
C2826762 (UMLS CUI [1])
Systolic Pressure
Item
Blood Pressure - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood Pressure - Diastolic
integer
C0428883 (UMLS CUI [1])
Item
Subject Position
text
C0518766 (UMLS CUI [1,1])
C1262869 (UMLS CUI [1,2])
Code List
Subject Position
CL Item
Standing (1)
CL Item
Semi-supine (2)
Heart rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Medical Conditions
C0012634 (UMLS CUI-1)
Disease, Diagnosis
Item
Diagnosis
text
C0012634 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Current or Past?
text
C0012634 (UMLS CUI [1,1])
C1444635 (UMLS CUI [1,2])
Code List
Current or Past?
CL Item
Current (1)
CL Item
Past (2)
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Physical Examination, Assessment Date
Item
Date of Assessment
date
C0031809 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item
Physical Examination
text
C0031809 (UMLS CUI [1,1])
C0678852 (UMLS CUI [1,2])
Code List
Physical Examination
CL Item
Hair and skin (1)
CL Item
Lymph nodes (2)
CL Item
Eyes (3)
CL Item
Ears, Nose and Throat (4)
CL Item
Breasts (5)
CL Item
Respiratory (6)
CL Item
Cardiovascular (7)
CL Item
Abdomen (8)
CL Item
Urogenital (9)
CL Item
Pelvic (10)
CL Item
Rectal (11)
CL Item
Musculoskeletal (12)
CL Item
Neurological (13)
CL Item
Mental status (14)
Item
Result
text
C0031809 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (2)
Physical Examination, Comment
Item
Comment
text
C0031809 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Allen's Test
C0231664 (UMLS CUI-1)
Allen test
Item
Was an Allen's Test performed?
boolean
C0231664 (UMLS CUI [1])
Item Group
Alcohol Intake
C0001948 (UMLS CUI-1)
Alcohol consumption
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
Alcohol consumption, alcohol units/week
Item
If Yes, record the average number of units of alcohol consumed per week
integer
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Item Group
Drug and Alcohol Screen
C0202274 (UMLS CUI-1)
C0202304 (UMLS CUI-2)
Urine drug screening, Ethanol measurement, Sampling, Date in time, Time
Item
Date and time of sample taken
datetime
C0202274 (UMLS CUI [1,1])
C0202304 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item
Cocaine
text
C0202274 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
Item
Amphetamines
text
C0202274 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
Item
Benzodiazepines
text
C0202274 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
Code List
Benzodiazepines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cannabinoids
text
C0202274 (UMLS CUI [1,1])
C0936079 (UMLS CUI [1,2])
Code List
Cannabinoids
CL Item
Positive (1)
CL Item
Negative (2)
Item
Opiates
text
C0202274 (UMLS CUI [1,1])
C0376196 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
Urine drug screening, Barbiturates
Item
Barbiturates
text
C0202274 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
Item
Cotinine
text
C0202274 (UMLS CUI [1,1])
C0202363 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
Item
Alcohol
text
C0202304 (UMLS CUI [1])
Code List
Alcohol
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Smokerlyser Breath Test
C2207180 (UMLS CUI-1)
breath test expired carbon monoxide, Sampling, Date in time
Item
Date sample taken
date
C2207180 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Results
text
C2207180 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Serology
C0036743 (UMLS CUI-1)
Serologic tests, Sampling, Date in time
Item
Date sample taken
date
C0036743 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
HIV antibody
text
C0036743 (UMLS CUI [1,1])
C0459958 (UMLS CUI [1,2])
Code List
HIV antibody
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis B surface antigen
text
C0036743 (UMLS CUI [1,1])
C0019168 (UMLS CUI [1,2])
Code List
Hepatitis B surface antigen
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis C antibody
text
C0036743 (UMLS CUI [1,1])
C0201487 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
M.I.N.I
C4505426 (UMLS CUI-1)
Mini International Neuropsychiatric Interview
Item
Has the M.I.N.I. assessment been performed?
boolean
C4505426 (UMLS CUI [1])
Item Group
Electronically Transferred Laboratory Data (Haematology)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Laboratory Procedures, Hematology finding, Sampling, Date in time
Item
Date Sample Taken
date
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Hematology finding, Sampling, Time
Item
Actual Time
time
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Electronically Transferred Laboratory Data (Clinical Chemistry)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time
Item
Date Sample Taken
date
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Chemistry, Clinical, Sampling, Time
Item
Actual Time
time
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Urinalysis, Sampling, Date in time
Item
Date Sample Taken
date
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Urinalysis, Sampling, Time
Item
Actual Time
time
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Electronically Transferred Laboratory Data (Renal Blood Monitoring)
C0022885 (UMLS CUI-1)
C0232804 (UMLS CUI-2)
C0005767 (UMLS CUI-3)
Laboratory Procedures, Renal function, Blood, Sampling, Date in time
Item
Date Sample Taken
date
C0022885 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
Laboratory Procedures, Renal function, Blood, Sampling, Time
Item
Actual Time
time
C0022885 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Electronically Transferred Laboratory Data (Renal Urine Monitoring)
C0022885 (UMLS CUI-1)
C0232804 (UMLS CUI-2)
C0042036 (UMLS CUI-3)
Laboratory Procedures, Renal function, Urine, Sampling, Date in time
Item
Date Sample Taken
date
C0022885 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
Laboratory Procedures, Renal function, Urine, Sampling, Time
Item
Actual Time
time
C0022885 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Item
ECG Number
text
C0430456 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Code List
ECG Number
CL Item
ECG1 (1)
CL Item
ECG2 (2)
CL Item
ECG3 (3)
CL Item
ECG4 (4)
CL Item
ECG5 (5)
CL Item
ECG6 (6)
12 lead ECG, Start Date
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Code List
Planned Relative Time
CL Item
Screening (1)
CL Item
Screening (2)
CL Item
Screening (3)
CL Item
Unscheduled (4)
CL Item
Unscheduled (5)
CL Item
Unscheduled (6)
12 lead ECG, Start time
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
12 lead ECG, Heart rate
Item
Heart Rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
12 lead ECG, PR interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
12 lead ECG, QRS complex duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
12 lead ECG, QT interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
12 lead ECG, Electrocardiogram QT corrected interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
Result of the ECG
text
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (not available) (4)
Item Group
Summary Holter
C0013801 (UMLS CUI-1)
Holter Electrocardiography, Start Date
Item
Start Date of Holter
date
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Holter Electrocardiography, Start time
Item
Start time of Holter
time
C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Holter Electrocardiography, End Date
Item
Stop date of Holter
date
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Holter Electrocardiography, End time
Item
Stop time of Holter
time
C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Interpretation of Holter
text
C0013801 (UMLS CUI [1,1])
C4086187 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant  (3)
CL Item
No result (4)
CL Item
Unable to evaluate (5)
Item
Holter monitoring method
text
C0013801 (UMLS CUI [1,1])
C0871511 (UMLS CUI [1,2])
Code List
Holter monitoring method
CL Item
12 Lead 1000Hz (1)
CL Item
12 lead 180Hz (2)
CL Item
3 Lead 180 Hz (3)
CL Item
Telemetry (4)
CL Item
5 Lead 512Hz (5)
CL Item
4 Lead 0.05-40 Hz (6)
CL Item
6 Lead 0.05-40 Hz (7)
CL Item
7 Lead 0.05-100 Hz-3dB (8)
CL Item
7 Lead 3 channel 133 Hz (9)
CL Item
2 Lead 200 Hz (10)
CL Item
Other (11)
Item Group
Eligibility Question
C0013893 (UMLS CUI-1)
Eligibility Determination
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Health status
Item
Healthy as determined by a reasonable and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with renal monitoring test values outside of the ranges in Appendix 2 (of the protocol) should always be excluded from enrolment.
boolean
C0018759 (UMLS CUI [1])
Gender; Age
Item
Male subject between 35 and 55 years of age inclusive, at the time of signing the informed consent.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Contraceptive methods
Item
Male subjects must agree to use one of the contraception methods listed in Section 8.1 (of the protocol). This criterion must be followed from the time the first administration of [11C]GSK1034702 until completion of the study and for 4 months after dosing.
boolean
C0700589 (UMLS CUI [1])
Body Weight; Body mass index
Item
Body weight >= 50kg and BMI within the range 19.0 - 29.0 kg/m2 (inclusive).
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Informed Consent
Item
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
boolean
C0021430 (UMLS CUI [1])
Allen test, Negative finding
Item
Adequate collateral flow to the radial and ulnar arteries in both hands as determined by the Allen's test.
boolean
C0231664 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Drug screen; Ethanol measurement
Item
A positive pre-study drug/alcohol screen. A minimum list of drug that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
boolean
C0373483 (UMLS CUI [1])
C0202304 (UMLS CUI [2])
Urine cotinine measurement, Tobacco use
Item
Urinary cotinine levels indicate of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
boolean
C1278256 (UMLS CUI [1,1])
C0543414 (UMLS CUI [1,2])
Alcohol consumption
Item
History of alcohol consumption within 6 months of the study defined as: - An average weekly intake of > 21 Units for males or > 14 units for females. One unit is equivalent to 8g of alcohol: a half-pint (240mL) of beer, 1 glass (125mL) of wine or 1 (25 mL) measure of spirits.
boolean
C0001948 (UMLS CUI [1])
Hepatitis B surface antigen positive; Hepatitis C antibody positive
Item
A positive pre-study Hepatitis B surface antigen (HBsAg) or positive Hepatitis C antibody result within 3 months of screening.
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
HIV antibody positive
Item
A positive test for human immunodeficiency virus (HIV) antibody.
boolean
C0920548 (UMLS CUI [1])
Electrocardiogram, Abnormality
Item
A screening ECG with a QTc value of >450msec (triplicate ECGs) and/or a PR interval outside the range 120 to 200msec (triplicate ECGs) or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T-wave)
boolean
C0013798 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Heart rate; Systolic Pressure; Diastolic blood pressure; Hypotension, Orthostatic
Item
Puls rate <50 or >90 BPM OR a systolic BP > 140 or <90 OR a diastolic BP >90 0r <60 OR orthostatic hypotension (reduction of systolic BP >10mmHg).
boolean
C0018810 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0020651 (UMLS CUI [4])
Long QT Syndrome; Cardiac conduction abnormality; Sudden death, Unexplained; Syncope, Unexplained; Heart Diseases
Item
History of long QT syndrome (personal or family) or other cardiac conduction disorder, a history of sudden unexplained death or unexplained syncope in a first degree relative or other clinically significant cardiac disease.
boolean
C0023976 (UMLS CUI [1])
C1842820 (UMLS CUI [2])
C0011071 (UMLS CUI [3,1])
C4288071 (UMLS CUI [3,2])
C0039070 (UMLS CUI [4,1])
C4288071 (UMLS CUI [4,2])
C0018799 (UMLS CUI [5])
Cardiovascular Diseases
Item
Subjects with current or past disease of cardiovascular disease including but not limited to hypertension, cardiac arrhythmias and/or risk factors for coronary artery disease.
boolean
C0007222 (UMLS CUI [1])
Gastrointestinal Diseases; Operative Surgical Procedures
Item
Current or recent (without one year) gastrointestinal disease; a history of malabsorption, oesophageal reflux, irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecystectomy) which would be expected to influence the absorption of drugs.
boolean
C0017178 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
Respiration Disorders
Item
Subjects who have current respiratory or a history of respiratory problems (e.g. asthma or allergies, including childhood conditions).
boolean
C0035204 (UMLS CUI [1])
Renal function, Abnormality
Item
Subjects who have current renal or history of clinically significant renal abnormalities.
boolean
C0232804 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
nervous system disorder
Item
History or presence of a neurological diagnosis (not limited to but including for example, stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, schizophrenia, major depression etc) that may influence the outcome or analysis of the scan results.
boolean
C0027765 (UMLS CUI [1])
Psychiatric History
Item
Any previous or current psychiatric history, as assessed by the M.I.N.I
boolean
C0748059 (UMLS CUI [1])
Suicidal behavior; Active suicidal ideation
Item
Any history of suicidal behavior or an suicidal ideation of type 4 or 5 on the CSSRS in the last month.
boolean
C3641604 (UMLS CUI [1])
C0749133 (UMLS CUI [2])
Mental handicap; legal capacity, Lacking
Item
Subject is mentally or legally incapacitated.
boolean
C1306341 (UMLS CUI [1])
C0683673 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Pharmaceutical Preparations
Item
Use of prescription or non-prescription drugs, including vitamins, herbal or dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
boolean
C0013227 (UMLS CUI [1])
Red wine, Citrus aurantium, Grapefruit, Grapefruit juice
Item
Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
boolean
C0349371 (UMLS CUI [1])
C0330922 (UMLS CUI [2])
C0995150 (UMLS CUI [3])
C0452456 (UMLS CUI [4])
Blood Donation
Item
Where participation in the study would result in donation of blood or blood products in excess of 500mL within a 56 day period
boolean
C0005794 (UMLS CUI [1])
Experimental drug, Hypersensitivity; Hypersensitivity, Other
Item
History of sensitivity to any of the study medications, or components thereof or a history or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
boolean
C0304229 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Study Subject Participation Status
Item
The subject has participated in a clinical trial and has received an IP within the following time period prior to the fist dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the IP (whichever is longer).
boolean
C2348568 (UMLS CUI [1])
Pharmaceutical Preparations
Item
Exposure to more than three new chemical entities within 12 months prior to the first dosing day.
boolean
C0013227 (UMLS CUI [1])
Protocol Compliance
Item
Unwillingness or inability to follow the procedures outlined in the protocol.
boolean
C0525058 (UMLS CUI [1])
Extensive Radiation
Item
Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden (a significant radiation burden being defined as >10mSv in addition to natural background in the previous 3 years). Or worked as a welder , metal worker or machinist.
boolean
C1517030 (UMLS CUI [1])
Claustrophobia; Magnetic Resonance Imaging, Unable; Positron emission tomography unit, Unable
Item
History of, or suffers from, claustrophobia or feels that he will be unable to lie still on his back in the PET or MRI scanner for a period of 1-2 h.
boolean
C0008909 (UMLS CUI [1])
C0024485 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0182349 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Artificial cardiac pacemaker; presence of metallic device / implant
Item
Presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies as assessed by a standard pre-MRI questionnaire
boolean
C0030163 (UMLS CUI [1])
C3693688 (UMLS CUI [2])
Item Group
12-Lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
12 lead ECG, Numbers
Item
ECG Number
integer
C0430456 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
12 lead ECG, Date in time
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
12 lead ECG, Time
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Rhythm
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
CL Item
Sinus bradycardia (1)
CL Item
Sinus bradycardia (heart rate 40-50 beats/min)  (2)
CL Item
Sinus bradycardia (heart rate 30-39 beats/min)  (3)
CL Item
Sinus bradycardia (heart rate < 30 beats/min) (4)
CL Item
Sinus pause (5)
CL Item
Sinus tachycardia (heart rate >100 beats/min)  (6)
CL Item
Ectopic supraventricular beats (7)
CL Item
Ectopic supraventricular rhythm (8)
CL Item
Wandering atrial pacemaker (9)
CL Item
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min) (10)
CL Item
Supraventricular tachycardia (heart rate >100 beats/min) (11)
CL Item
Atrial flutter (12)
CL Item
Atrial fibrillation (13)
CL Item
Junctional rhythm (heart rate ≤100 beats/min) (14)
CL Item
Junctional rhythm (15)
CL Item
Junctional tachycardia (heart rate > 100beats/min)  (16)
CL Item
Ectopic ventricular beats (17)
CL Item
Ventricular couplets (18)
CL Item
Bigeminy (19)
CL Item
Trigeminy (20)
CL Item
Electrical alternans (21)
CL Item
R on T phenomenon (22)
CL Item
Ventricular fibrillation (23)
CL Item
Idioventricular rhythm (heart rate < 100 beats/min) (24)
CL Item
Sustained ventricular tachycardia (25)
CL Item
Non-sustained ventricular tachycardia (26)
CL Item
Wide QRS Tachycardia (diagnosis unknown) (27)
CL Item
Ventricular tachycardia (28)
CL Item
Monomorphic ventricular tachycardia (29)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (30)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (31)
CL Item
Artificial pacemaker  (32)
CL Item
Other abnormal rhythm (33)
12 lead ECG, Abnormality, Rhythm
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
Item
P-Wave and QRS Morphology
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
C0429098 (UMLS CUI [1,4])
CL Item
Left atrial abnormality (P mitrale)  (1)
CL Item
Right atrial abnormality (P pulmonale)  (2)
CL Item
Right ventricular hypertrophy  (3)
CL Item
Intraatrial conduction delay (4)
CL Item
Increased voltage consistent with left ventricular hypertrophy (5)
CL Item
Other morphology (6)
12 lead ECG, Abnormality, electrocardiogram: P wave shifting morphology; Electrocardiogram QRS complex
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
C0429098 (UMLS CUI [1,4])
Item
Conduction
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
CL Item
First degree AV block (PR interval > 200 msec) (1)
CL Item
Short PR interval (2)
CL Item
Second degree AV block (Mobitz type 1) (3)
CL Item
Second degree AV block (Mobitz type 2)  (4)
CL Item
2:1 AV block (5)
CL Item
Third degree AV block (6)
CL Item
Left axis deviation (QRS axis more negative than -30°) (7)
CL Item
Right axis deviation (QRS axis more positive than +110°) (8)
CL Item
Incomplete right bundle branch block  (9)
CL Item
Incomplete left bundle branch block (10)
CL Item
Right bundle branch block (11)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (12)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (13)
CL Item
Left bundle branch block (14)
CL Item
Bifascicular block (15)
CL Item
Non-specific intraventricular conduction delay (QRS ≥ 120 msec) (16)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (17)
CL Item
Prolonged QT interval  (18)
CL Item
QT/QTc prolongation ≥ 500 msec  (19)
CL Item
AV dissociation (20)
CL Item
Other conduction (21)
12 lead ECG, Abnormality, Cardiac Conduction
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
Item
Myocardial Infarction
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
CL Item
Myocardial infarction, old  (1)
CL Item
Myocardial infarction, anterior  (2)
CL Item
Myocardial infarction, lateral  (3)
CL Item
Myocardial infarction, posterior  (4)
CL Item
Myocardial infarction, inferior (5)
CL Item
Myocardial infarction, septal  (6)
CL Item
Myocardial infarction, Non-Q wave  (7)
CL Item
Other myocardial infarction (8)
12 lead ECG, Abnormality, Myocardial Infarction
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
Item
Depolarisation/Repolarisation (QRS-T)
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0948857 (UMLS CUI [1,4])
CL Item
Non-specific ST-T changes  (1)
CL Item
J point elevation (2)
CL Item
ST elevation  (3)
CL Item
ST elevation-pericarditis (4)
CL Item
ST depression  (5)
CL Item
U waves abnormal (6)
CL Item
T wave inversion  (7)
CL Item
T wave peaked (8)
CL Item
T waves flat (9)
CL Item
T waves biphasic  (10)
CL Item
Notched T-waves (11)
CL Item
Low QRS voltage  (12)
CL Item
T-wave flattening/inversion  (13)
CL Item
Other depolarisation/repolarisation (14)
12 lead ECG, Abnormality, Ventricular Depolarization [PE], Electrocardiogram repolarisation abnormality
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0948857 (UMLS CUI [1,4])
Item
Other Abnormalities
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Code List
Other Abnormalities
CL Item
Other abnormalities (1)
12 lead ECG, Abnormality, Other
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Summary Holter Abnormalities
C0013801 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
Holter Electrocardiography, Start Date
Item
Start Date of Holter
date
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Holter Electrocardiography, End Date
Item
Stop Date of Holter
date
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Holter Electrocardiography, Start Time
Item
Start Time of Holter
date
C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Holter Electrocardiography, End Time
Item
Stop Time of Holter
time
C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Record clinically significant abnormalities below
text
C0013801 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Code List
Record clinically significant abnormalities below
CL Item
Sinus bradycardia (50-59 beats/min) (1)
CL Item
Sinus bradycardia (40-49 beats/min)  (2)
CL Item
Sinus bradycardia (30-39 beats/min)  (3)
CL Item
Sinus bradycardia (< 30 beats/min) (4)
CL Item
Sinus pause (5)
CL Item
Sinus tachycardia (>100 beats/min)  (6)
CL Item
Ectopic supraventricular beats (7)
CL Item
Ectopic supraventricular rhythm (8)
CL Item
Wandering atrial pacemaker (9)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (10)
CL Item
Non-sustained supraventricular tachycardia (>100 beats/min, 3-30 beats)) (11)
CL Item
Sustained supraventricular tachycardia (>100 beats/min, >30 beats)) (12)
CL Item
Atrial flutter (13)
CL Item
Atrial fibrillation (14)
CL Item
Junctional rhythm (<=100beats/min, defined by narrow QRS complexes)  (15)
CL Item
Junctional tachycardia (heart rate >100 beats/min) (16)
CL Item
Ventricular premature depolarisation (17)
CL Item
Ventricular couplets (18)
CL Item
Bigeminy (19)
CL Item
Trigeminy (20)
CL Item
Electrical alternans (21)
CL Item
R on T phenomenon (22)
CL Item
Ventricular fibrillation (23)
CL Item
Idioventricular rhythm (<= 100 beats/min, defined by wide QRS complexes) (24)
CL Item
Non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (25)
CL Item
Sustained ventricular tachycardia (>100 beats/min, >30 beats) (26)
CL Item
Wide QRS Tachycardia (diagnosis unknown) (27)
CL Item
Monomorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (28)
CL Item
Monomorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (29)
CL Item
Polymorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (30)
CL Item
Polymorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (31)
CL Item
Torsades de Pointes (TdP) (32)
CL Item
Pacemaker (33)
CL Item
First degree AV block (PR interval > 200 msec) (34)
CL Item
Short PR interval (35)
CL Item
Second degree AV block (Mobitz type 1) (36)
CL Item
Second degree AV block (Mobitz type 2)  (37)
CL Item
2:1 AV block (38)
CL Item
Third degree AV block (39)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees) (40)
CL Item
Right axis deviation (QRS axis more positive than +110 degrees) (41)
CL Item
Incomplete right bundle branch block  (42)
CL Item
Incomplete left bundle branch block (43)
CL Item
Right bundle branch block (44)
CL Item
Left anterior hemiblock  (45)
CL Item
Left posterior hemiblock (46)
CL Item
Left bundle branch block (47)
CL Item
Bifascicular block (48)
CL Item
Non-specific intraventricular conduction delay (QRS ≥ 120 msec) (49)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)  (50)
CL Item
QTc prolongation ≥ 500 msec  (51)
CL Item
AV dissociation (52)
CL Item
Myocardial infarction, old  (53)
CL Item
Myocardial infarction, Non-Q wave  (54)
CL Item
Non-specific ST-T changes  (55)
CL Item
J point elevation (56)
CL Item
ST elevation  (57)
CL Item
ST depression  (58)
CL Item
ST segment abnormally (59)
CL Item
U waves (60)
CL Item
T wave inversion  (61)
CL Item
T wave peaked (62)
CL Item
T waves biphasic  (63)
CL Item
T waves flat (64)
CL Item
Notched T-waves (65)
CL Item
Low QRS voltage  (66)
CL Item
T wave abnormality (67)
Holter Eletrocardiography, Abnormality, Electrocardiogram, rhythm
Item
Other abnormal rhythm, Comment
text
C0013801 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
Holter Eletrocardiography, Abnormality, electrocardiogram: P wave shifting morphology, Electrocardiogram QRS complex
Item
Other morphology, Comment
text
C0013801 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
C0429098 (UMLS CUI [1,4])
Holter Eletrocardiography, Abnormality, Cardiac conduction
Item
Other conduction, Comment
text
C0013801 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
Holter Eletrocardiography, Abnormality, Ventricular Depolarization, Electrocardiogram repolarisation abnormality
Item
Other depolarisation/repolarization, Comment
text
C0013801 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0948857 (UMLS CUI [1,4])
Holter Eletrocardiography, Abnormality, Other, Comment
Item
Other abnormality/Cardiologist comments
text
C0013801 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial