ID

29852

Beschreibung

Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: Screening

Link

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

Stichworte

Versionen (2)
  1. 24.04.18 24.04.18 -
  2. 30.04.18 30.04.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

24. April 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061

Englisch

Screening

1 Formulare  
  1. StudyEvent: ODM
    1. Screening
Date of Visit
Beschreibung

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Demography
Beschreibung

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

integer

Alias
UMLS CUI [1]
C0079399
If female, record childbearing potential
Beschreibung

Childbearing potential

Datentyp

integer

Alias
UMLS CUI [1]
C3831118
Ethnicity
Beschreibung

Ethnicity

Datentyp

integer

Alias
UMLS CUI [1]
C0015031
Geographic ancestry, check all that apply
Beschreibung

Geographic ancestry

Datentyp

integer

Alias
UMLS CUI [1,1]
C3841890
UMLS CUI [1,2]
C0034510
Cohort
Beschreibung

Cohort

Alias
UMLS CUI-1
C0599755
UMLS CUI-2
C0008976
Cohort
Beschreibung

Cohort

Datentyp

integer

Alias
UMLS CUI [1]
C0599755
Vital Signs
Beschreibung

Vital Signs

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

Actual date of vital signs

Datentyp

date

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

Actual time of vital signs

Datentyp

time

Alias
UMLS CUI [1]
C2826762
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Beschreibung

Body mass index

Datentyp

float

Alias
UMLS CUI [1]
C1305855
Position
Beschreibung

Position

Datentyp

integer

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

Systolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure: Diastolic
Beschreibung

Diastolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Respiration rate
Beschreibung

Respiration rate

Datentyp

integer

Maßeinheiten
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Temperature
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • C
Alias
UMLS CUI [1]
C0005903
C
12-lead ECG
Beschreibung

12-lead ECG

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

Start Date of ECG

Datentyp

date

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

Start Time of ECG

Datentyp

time

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

Heart Rate

Datentyp

integer

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

PR Interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0429087
UMLS CUI [1,2]
C0430456
msec
QRS Duration
Beschreibung

QRS Duration

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0429025
UMLS CUI [1,2]
C0430456
msec
Uncorrected QT Interval
Beschreibung

Uncorrected QT Interval

Datentyp

float

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

Method of QTC Measurement

Datentyp

integer

Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C1299991
Method of QTC Measurement. If machine, record the QTC values(s) generated by the machine: QTcB
Beschreibung

QTcB

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C0855331
msec
Method of QTC Measurement. If machine, record the QTC values(s) generated by the machine: QTcF
Beschreibung

QTcF

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C1882513
UMLS CUI [1,2]
C0855331
msec
Method of QTC Measurement. If manual, record the RR interval that precedes the measured QT interval
Beschreibung

RR interval

Datentyp

float

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

(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)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C0430456
Eligibility Question
Beschreibung

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Beschreibung

If no, please select all boxes corresponding to violations of any inclusion/exclusion criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C1516637
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a significant clinical aboonnality or laboratory finding significantly 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 lo introduce additional risk factors and will not interfere with the study integrity.
Beschreibung

Inclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C1512693
AST, ALT, alkaline phosphatase and bilirubin =< I .5xULN (isolated bilirubin > I .5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Beschreibung

Inclusion criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C1512693
Male or female between 18 and 50 years of age inclusive, at the time of signing the informed consent. Males between 18 and 50 years of age inclusive, at the time of signing the informed consent will be eligible for the PET portion of the study.
Beschreibung

Inclusion criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C1512693
Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 90 days after last dose.
Beschreibung

Inclusion criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C1512693
A female subject is eligible to participate if she is: • Of child-bearing potential and agree to use one of the contraception methods listed in Section 8.1 Female subjects currently on oral, patch or depot honnonal contraception must agree to the additional contraceptive measures listed in Section 8.1 Female subjects must agree to use contraception ulllil 90 days after last dose.; • Of non-childbearing potential defined as pre-menopausal females with a documented tuba! ligation or hysterectomy; or postmenopausal defined as at least 12 consecutive months of spontaneous amenorrhea [In questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MIU/ ml and estradiol < 40 pg/ml (< 140 pmol/L) is confinnatory.]. Females on honnone replacement therapy (HRT) and whose menopausal stan1s is in doubt will be required to use one of the contraception methods in Section 8.1.
Beschreibung

Inclusion criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C1512693
Body weight=> 50 kg and BMI within the range 19.0 to 30.0 kg/m2 (inclusive).
Beschreibung

Inclusion criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C1512693
Capable of giving wrinen infonned consent, which includes compliance with the requirements and restrictions listed in the consent form.
Beschreibung

Inclusion criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C1512693
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
The subject has personal or family history of prolonged QTc, a personal history of arrhythmia, a history of sudden unexplained death in a first degree relative, or unexplained syncope in a first degree relative.
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
Pulse rate <SO or > I 00 bpm OR a systolic blood pressure > 140 or <95 OR a diastolic blood pressure >90 or <50tnmHg at screening and/or baseline. These maybe repeated af'ter discussion with the GSK medical monitor.
Beschreibung

Exclusion Criteria

Datentyp

text

Alias
UMLS CUI [1]
C0680251
A screening ECG with a QTc (QTcB and/or QTcF) value of>450msec or a PR interval outside the range 120 to 200msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the Twave) at screening or baseline. These maybe repeated once after discussion with the GSK medical monitor.
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
A positive pre-study drug/alcohol screen.
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
A positive test for HIV antibody.
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
History of regular alcohol consumption within 6 months of the study defined as: An average weekly i11take of>2 I units for males or > 14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (- 240 ml) of beer, I glass (125 ml) of wine or I (25 ml) measure of spirits.
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effoct of the investigational product (whichever is longer).
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
Exposure to more than four new chemical entities within 12 months prior to the first dosiug day.
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St Johns Wort) within 7 days ( or 14 days if the drug is a potential enzyme inducer) or 5 hali~ 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 stl1dy procedures or compromise subject safety.
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
History of sensitivity to any of tbe study medications, or components thereof or a bistory of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
Pregnant females as determined by positive serum hCG test at screening or prior to dosing.
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
Lactating females or those who were lactating in the month preceding enrolment.
Beschreibung

Exclusion Criteria

Datentyp

text

Alias
UMLS CUI [1]
C0680251
Unwillingness or inability to follow the procedures outlined in the protocol.
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
Subject is mentally or legally incapacitated.
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
Consumption ofred wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic c itrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication and throughout the duration of the study.
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
Subjects, who in the investigator's judgement, pose a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behavior and/or any suicidal ideation of type 4 or 5 on the C-SSRS in the last 6 months.
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
Previous inclusion in a research and/or medical protoco I involving nuclear medicine, PET or radiological investigations with significant radiation burden (a significant radiation burden being defined as ICRP category lib or above i.e. No more than 10 rnSv in addition to the natural background radiation) in the previous 3 years u1cluding the dose from the study.
Beschreibung

The following apply to PET subjects only:

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
History of or suffers from claustrophobia or feels that he will be unable to lie still on his back in the PET camera for a period of 90 minutes.
Beschreibung

The following apply to PET subjects only:

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
History of a neurological/psychiatric diagnosis (not limited to but including for example, stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parku1sons disease, vascular dementia, transient ischemic attack, schizophrenia, majo r depressiou etc) that may influence the outcome or analysis of the scan results.
Beschreibung

The following apply to PET subjects only:

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
Presence of a cardiac pacemaker or other electronic device or potential for ferromagnetic metal foreign bodies, such as staples, as assessed by a standard pre- MRI questionnaire.
Beschreibung

The following apply to PET subjects only:

Datentyp

text

Alias
UMLS CUI [1]
C0680251
Subject Identification
Beschreibung

Subject Identification

Alias
UMLS CUI-1
C2348585
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Holter ECG Results
Beschreibung

Holter ECG Results

Alias
UMLS CUI-1
C0013801
Start Date Holter ECG
Beschreibung

Start Date Holter ECG

Datentyp

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
Start Time Holter ECG
Beschreibung

Start Time Holter ECG

Datentyp

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1301880
Stop Date Holter ECG
Beschreibung

Stop Date Holter ECG

Datentyp

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
Stop Time Holter ECG
Beschreibung

Stop Time Holter ECG

Datentyp

time

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

Interpretation of Holter ECG

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0438154
Record clinically significant abnormalities below, check all that apply
Beschreibung

INCLUDE ABNORMALITIES FOR HOLTER AT THIS VISIT ONLY

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0522055
If Other morphology, please specify
Beschreibung

morphology

Datentyp

text

Alias
UMLS CUI [1,1]
C0332437
UMLS CUI [1,2]
C0013801
If Other abnormal rhythm, please specify
Beschreibung

abnormal rhythm

Datentyp

text

Alias
UMLS CUI [1,1]
C0232187
UMLS CUI [1,2]
C0013801
If Other conduction, please specify
Beschreibung

conduction

Datentyp

text

Alias
UMLS CUI [1,1]
C0232219
UMLS CUI [1,2]
C0013801
If Other myocardial infarction, please specify
Beschreibung

myocardial infarction

Datentyp

text

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0013801
If Other depolarisation/repolarisation, please specify
Beschreibung

depolarisation/repolarisation

Datentyp

text

Alias
UMLS CUI [1,1]
C0948857
UMLS CUI [1,2]
C0013801
If Other abnormality/Cardiologist comments, please specify
Beschreibung

Other abnormality Holter ECG

Datentyp

text

Alias
UMLS CUI [1,1]
C1832603
UMLS CUI [1,2]
C0013801
Menstrual cycle profile
Beschreibung

Menstrual cycle profile

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

Date of start of last menstrual period

Datentyp

date

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

Date of end of last menstrual period

Datentyp

date

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

Haematology

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

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

Datentyp

datetime

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

Fasting

Datentyp

boolean

Alias
UMLS CUI [1]
C0015663
Haematology, Type of result
Beschreibung

Type of result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0332307
White blood cell count (WBC)
Beschreibung

White blood cell count

Datentyp

text

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

Red blood cell count

Datentyp

text

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

Haemoglobin

Datentyp

text

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

Haematocrit

Datentyp

text

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

Neutrophil count

Datentyp

text

Alias
UMLS CUI [1]
C0948762
Lymphocytes
Beschreibung

Lymphocyte count

Datentyp

text

Alias
UMLS CUI [1]
C0200635
Monocytes
Beschreibung

Monocyte count

Datentyp

text

Alias
UMLS CUI [1]
C0200637
Eosinophils
Beschreibung

Eosinophil count

Datentyp

text

Alias
UMLS CUI [1]
C0200638
Basophis
Beschreibung

Basophil count

Datentyp

text

Alias
UMLS CUI [1]
C0200641
Platelets
Beschreibung

Platelet count

Datentyp

text

Alias
UMLS CUI [1]
C0032181
Reticulocytes
Beschreibung

Reticulocyte count

Datentyp

text

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

Mean cell volume

Datentyp

text

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

Mean cell haemoglobin

Datentyp

text

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

Mean cell haemoglobin concentration

Datentyp

text

Alias
UMLS CUI [1]
C0474535
Clinical Chemistry
Beschreibung

Clinical Chemistry

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

Date and time sample taken

Datentyp

datetime

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

Fasting

Datentyp

boolean

Alias
UMLS CUI [1]
C0015663
Clinical Chemistry, type of result
Beschreibung

Type of result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0332307
Alkaline phasphatase
Beschreibung

Alkaline phosphatase

Datentyp

text

Alias
UMLS CUI [1]
C0201850
Alanine transaminase
Beschreibung

Alanine transaminase

Datentyp

text

Alias
UMLS CUI [1]
C0201836
Total Bilirubin
Beschreibung

Total Bilirubin

Datentyp

text

Alias
UMLS CUI [1]
C0201913
Direct Bilirubin
Beschreibung

Direct Bilirubin

Datentyp

text

Alias
UMLS CUI [1]
C0201916
Glucose
Beschreibung

Glucose

Datentyp

text

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

Gamma-glutamyl transpeptidase

Datentyp

text

Alias
UMLS CUI [1]
C0202035
Total protein
Beschreibung

Total protein

Datentyp

text

Alias
UMLS CUI [1]
C0555903
Albumin
Beschreibung

Albumin

Datentyp

text

Alias
UMLS CUI [1]
C0201838
Potassium
Beschreibung

Potassium

Datentyp

text

Alias
UMLS CUI [1]
C0202194
Sodium
Beschreibung

Sodium

Datentyp

text

Alias
UMLS CUI [1]
C0337443
Chloride
Beschreibung

Chloride

Datentyp

text

Alias
UMLS CUI [1]
C0201952
Urea
Beschreibung

Urea

Datentyp

text

Alias
UMLS CUI [1]
C0523961
Creatinine
Beschreibung

Creatinine

Datentyp

text

Alias
UMLS CUI [1]
C0201975
Calcium
Beschreibung

Calcium

Datentyp

text

Alias
UMLS CUI [1]
C0201925
Bicarbonate
Beschreibung

Bicarbonate

Datentyp

text

Alias
UMLS CUI [1]
C0202059
Triglycerides
Beschreibung

Triglycerides

Datentyp

text

Alias
UMLS CUI [1]
C0202236
Cholesterol
Beschreibung

Cholesterol

Datentyp

text

Alias
UMLS CUI [1]
C0201950
LDL
Beschreibung

LDL

Datentyp

text

Alias
UMLS CUI [1]
C0428474
HDL
Beschreibung

HDL

Datentyp

text

Alias
UMLS CUI [1]
C0428472
Uric Acid
Beschreibung

Uric Acid

Datentyp

text

Alias
UMLS CUI [1]
C0202239
Alkaline Phosphatase
Beschreibung

Alkaline Phosphatase

Datentyp

text

Alias
UMLS CUI [1]
C0201850
Urinalysis - Local
Beschreibung

Urinalysis - Local

Alias
UMLS CUI-1
C0042014
Date sample taken
Beschreibung

Date sample taken

Datentyp

date

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

Time sample taken

Datentyp

time

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

If positive, record results of individual tests below.

Datentyp

integer

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

If Yes, provide details on the MICROSCOPY form

Datentyp

boolean

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

Urinalysis - Local: Dipstick Details

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0430370
UMLS CUI-3
C0022885
Urinalysis, Type of result
Beschreibung

Type of result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0332307
Urine Protein
Beschreibung

Urine Protein

Datentyp

text

Alias
UMLS CUI [1]
C0430371
Urine Glucose
Beschreibung

Urine Glucose

Datentyp

text

Alias
UMLS CUI [1]
C0430376
Urine Ketones
Beschreibung

Urine Ketones

Datentyp

text

Alias
UMLS CUI [1]
C0430377
Urine Blood
Beschreibung

Urine Blood

Datentyp

text

Alias
UMLS CUI [1]
C0430372
Urine pH
Beschreibung

Urine pH

Datentyp

text

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

Urine Specific Gravity

Datentyp

text

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

Urinalysis - Local: Microscopy Details

Alias
UMLS CUI-1
C0430397
UMLS CUI-2
C0042014
Urinalysis, Type of result
Beschreibung

Type of result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0332307
White blood cells
Beschreibung

White blood cells

Datentyp

text

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

Red Blood Cells

Datentyp

text

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

Hyaline casts

Datentyp

text

Alias
UMLS CUI [1]
C0427894
Cellular casts
Beschreibung

Cellular casts

Datentyp

text

Alias
UMLS CUI [1,1]
C2699157
UMLS CUI [1,2]
C0430397
Local Laboratory - Clinical Chemistry
Beschreibung

Local Laboratory - Clinical Chemistry

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

Date and time sample taken

Datentyp

datetime

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

Fasting

Datentyp

boolean

Alias
UMLS CUI [1]
C0015663
Clinical Chemistry, type of result
Beschreibung

Type of result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0332307
TSH
Beschreibung

TSH

Datentyp

text

Alias
UMLS CUI [1]
C0202230
GH
Beschreibung

GH

Datentyp

text

Alias
UMLS CUI [1]
C0037663
Total Testosterone
Beschreibung

Total Testosterone

Datentyp

text

Alias
UMLS CUI [1]
C0202227
Free Testosterone
Beschreibung

Free Testosterone

Datentyp

text

Alias
UMLS CUI [1]
C0202228
LH
Beschreibung

LH

Datentyp

text

Alias
UMLS CUI [1]
C0202123
FSH
Beschreibung

FSH

Datentyp

text

Alias
UMLS CUI [1]
C0202022
Estradiol
Beschreibung

(Females only)

Datentyp

text

Alias
UMLS CUI [1]
C0337434
Prolactin
Beschreibung

Prolactin

Datentyp

text

Alias
UMLS CUI [1]
C0373706
Randomisation
Beschreibung

Randomisation

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

Randomisation

Datentyp

boolean

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

Randomisation number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Date of randomisation
Beschreibung

Date of randomisation

Datentyp

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Screening

1 Formulare
  1. StudyEvent: ODM
    1. Screening
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Female (2)
CL Item
Male (1)
Item
If female, record childbearing potential
integer
C3831118 (UMLS CUI [1])
Childbearing potential
Code List
If female, record childbearing potential
CL Item
Pre-menarcheal (1)
CL Item
Post-menopausal (2)
CL Item
Sterile (of child-bearing age) (3)
CL Item
Potentially able to bear children (4)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Race
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Geographic ancestry, check all that apply
integer
C3841890 (UMLS CUI [1,1])
C0034510 (UMLS CUI [1,2])
Geographic ancestry
Code List
Geographic ancestry, check all that apply
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
Cohort
C0599755 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Item
Cohort
integer
C0599755 (UMLS CUI [1])
Cohort
Code List
Cohort
CL Item
Cohort I (1)
CL Item
Cohort 2 (2)
CL Item
Cohort 3 (3)
CL Item
PET (4)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Actual date of vital signs
Item
Actual date of vital signs
date
C2826644 (UMLS CUI [1])
Actual time of vital signs
Item
Actual time of vital signs
time
C2826762 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Item
Position
integer
C1262869 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Position
Code List
Position
CL Item
Semi Supine (1)
Systolic Blood Pressure
Item
Blood Pressure: Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Blood Pressure: Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Respiration rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item Group
12-lead ECG
C0430456 (UMLS CUI-1)
C1623258 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Item
Method of QTC Measurement
integer
C0489625 (UMLS CUI [1,1])
C1299991 (UMLS CUI [1,2])
Method ofQTC Measurement
Code List
Method of QTC Measurement
CL Item
Machine (1)
CL Item
Manual (2)
QTcB
Item
Method of QTC Measurement. If machine, record the QTC values(s) generated by the machine: QTcB
float
C1882512 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
QTcF
Item
Method of QTC Measurement. If machine, record the QTC values(s) generated by the machine: QTcF
float
C1882513 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
RR interval
Item
Method of QTC Measurement. If manual, record the RR interval that precedes the measured QT interval
float
C0489636 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant  (2)
CL Item
Abnormal- clinically significant (3)
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
entry criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Inclusion Criteria
Item
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a significant clinical aboonnality or laboratory finding significantly 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 lo introduce additional risk factors and will not interfere with the study integrity.
boolean
C1512693 (UMLS CUI [1])
Inclusion criteria
Item
AST, ALT, alkaline phosphatase and bilirubin =< I .5xULN (isolated bilirubin > I .5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
boolean
C1512693 (UMLS CUI [1])
Inclusion criteria
Item
Male or female between 18 and 50 years of age inclusive, at the time of signing the informed consent. Males between 18 and 50 years of age inclusive, at the time of signing the informed consent will be eligible for the PET portion of the study.
boolean
C1512693 (UMLS CUI [1])
Inclusion criteria
Item
Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 90 days after last dose.
boolean
C1512693 (UMLS CUI [1])
Inclusion criteria
Item
A female subject is eligible to participate if she is: • Of child-bearing potential and agree to use one of the contraception methods listed in Section 8.1 Female subjects currently on oral, patch or depot honnonal contraception must agree to the additional contraceptive measures listed in Section 8.1 Female subjects must agree to use contraception ulllil 90 days after last dose.; • Of non-childbearing potential defined as pre-menopausal females with a documented tuba! ligation or hysterectomy; or postmenopausal defined as at least 12 consecutive months of spontaneous amenorrhea [In questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MIU/ ml and estradiol < 40 pg/ml (< 140 pmol/L) is confinnatory.]. Females on honnone replacement therapy (HRT) and whose menopausal stan1s is in doubt will be required to use one of the contraception methods in Section 8.1.
boolean
C1512693 (UMLS CUI [1])
Inclusion criteria
Item
Body weight=> 50 kg and BMI within the range 19.0 to 30.0 kg/m2 (inclusive).
boolean
C1512693 (UMLS CUI [1])
Inclusion criteria
Item
Capable of giving wrinen infonned consent, which includes compliance with the requirements and restrictions listed in the consent form.
boolean
C1512693 (UMLS CUI [1])
Exclusion Criteria
Item
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
The subject has personal or family history of prolonged QTc, a personal history of arrhythmia, a history of sudden unexplained death in a first degree relative, or unexplained syncope in a first degree relative.
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
Pulse rate <SO or > I 00 bpm OR a systolic blood pressure > 140 or <95 OR a diastolic blood pressure >90 or <50tnmHg at screening and/or baseline. These maybe repeated af'ter discussion with the GSK medical monitor.
text
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
A screening ECG with a QTc (QTcB and/or QTcF) value of>450msec or a PR interval outside the range 120 to 200msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the Twave) at screening or baseline. These maybe repeated once after discussion with the GSK medical monitor.
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
A positive pre-study drug/alcohol screen.
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
A positive test for HIV antibody.
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
History of regular alcohol consumption within 6 months of the study defined as: An average weekly i11take of>2 I units for males or > 14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (- 240 ml) of beer, I glass (125 ml) of wine or I (25 ml) measure of spirits.
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effoct of the investigational product (whichever is longer).
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
Exposure to more than four new chemical entities within 12 months prior to the first dosiug day.
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St Johns Wort) within 7 days ( or 14 days if the drug is a potential enzyme inducer) or 5 hali~ 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 stl1dy procedures or compromise subject safety.
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
History of sensitivity to any of tbe study medications, or components thereof or a bistory of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
Pregnant females as determined by positive serum hCG test at screening or prior to dosing.
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
Lactating females or those who were lactating in the month preceding enrolment.
text
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
Unwillingness or inability to follow the procedures outlined in the protocol.
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
Subject is mentally or legally incapacitated.
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
Consumption ofred wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic c itrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication and throughout the duration of the study.
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
Subjects, who in the investigator's judgement, pose a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behavior and/or any suicidal ideation of type 4 or 5 on the C-SSRS in the last 6 months.
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
Previous inclusion in a research and/or medical protoco I involving nuclear medicine, PET or radiological investigations with significant radiation burden (a significant radiation burden being defined as ICRP category lib or above i.e. No more than 10 rnSv in addition to the natural background radiation) in the previous 3 years u1cluding the dose from the study.
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
History of or suffers from claustrophobia or feels that he will be unable to lie still on his back in the PET camera for a period of 90 minutes.
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
History of a neurological/psychiatric diagnosis (not limited to but including for example, stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parku1sons disease, vascular dementia, transient ischemic attack, schizophrenia, majo r depressiou etc) that may influence the outcome or analysis of the scan results.
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
Presence of a cardiac pacemaker or other electronic device or potential for ferromagnetic metal foreign bodies, such as staples, as assessed by a standard pre- MRI questionnaire.
text
C0680251 (UMLS CUI [1])
Item Group
Subject Identification
C2348585 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Holter ECG Results
C0013801 (UMLS CUI-1)
Start Date Holter ECG
Item
Start Date Holter ECG
date
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time Holter ECG
Item
Start Time Holter ECG
time
C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Stop Date Holter ECG
Item
Stop Date Holter ECG
date
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Stop Time Holter ECG
Item
Stop Time Holter ECG
time
C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Interpretation of Holter ECG
integer
C0013801 (UMLS CUI [1,1])
C0438154 (UMLS CUI [1,2])
Interpretation of Holter ECG
Code List
Interpretation of Holter ECG
CL Item
Normal (1)
CL Item
Abnormal, Not clinically significant (2)
CL Item
Abnormal, Clinically significant (3)
Item
Record clinically significant abnormalities below, check all that apply
integer
C0013801 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
Holter ECG Abnormalities
Code List
Record clinically significant abnormalities below, check all that apply
CL Item
No abnormalities (1)
CL Item
Sinus bradycardia (50-59 beats/min) (2)
CL Item
Sinus bradycardia (40-49 beats/min) (3)
CL Item
Sinus bradycardia (30-39 beats/min) (4)
CL Item
Sinus bradycardia (<30 beats/min) (5)
CL Item
Sinus pause (6)
CL Item
Sinus tachycardia (>100 beats/min) (7)
CL Item
Ectopic supraventricular beats (8)
CL Item
Ectopic supraventricular rhythm (9)
CL Item
Wandering atrial pacemaker (10)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate> 100 beats/min) (11)
CL Item
Non-sustained supra ventricular tachycardia(> 100 beats/min, 3-30 beats) (12)
CL Item
Sustained supraventricular tachycardia(> 100 beats/min, >30 beats) (13)
CL Item
Atrial flutter (14)
CL Item
Atrial fibrillation (15)
CL Item
Junctional rhythm (<=100 beats/min, defined by narrow QRS complex) (16)
CL Item
Junctional tachycardia (> I 00 beats/min) (17)
CL Item
Ventricular premat11re depolarisation (18)
CL Item
Ventricular couplets (19)
CL Item
Bigeminy (20)
CL Item
Trigeminy (21)
CL Item
Electrical alternans (22)
CL Item
R on T phenomenon (23)
CL Item
Ventricular fibrillation (24)
CL Item
Idioventricular rhytlun (<=100 beats/min, defined by wide QRS complex) (25)
CL Item
Non-sustained ventricular tachycardia (> I 00 beats/min, 3-30 beats) (26)
CL Item
Sustained ventricular tachycardia (>100 beats/min, >30 beats) (27)
CL Item
Wide QRS tachycardia (diagnosis unknown) (28)
CL Item
Monomorphic non-sustained ventricular tachycardia (> I 00 beats/min, 3-30 beats) (29)
CL Item
Monomorphic sustained ventricular tachycardia (> I 00 beats/min,>30 beats) (30)
CL Item
Polymorphic non-sustained ventricular tachycardia(> 100 beats/min, 3-30 beats) (31)
CL Item
Polymorphic sustained ventricular tachycardia(> JOO beats/min, >30 beats) (32)
CL Item
Torsade de Pointes (TdP) (33)
CL Item
Pacemaker (34)
CL Item
First degree AV block (PR interval >200msec) (35)
CL Item
Short PR Interval (36)
CL Item
Second degree AV block (Mobitz type I) (37)
CL Item
Second degree AV block (Mobitz type 2) (38)
CL Item
2:1 AV block (39)
CL Item
Third degree AV block (40)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees) (41)
CL Item
Right axis deviation (QRS axis more positive than + 110 degrees) (42)
CL Item
Incomplete right bundle branch block (43)
CL Item
Incomplete left bundle branch block (44)
CL Item
Right bundle branch block (45)
CL Item
Left anterior hemiblock (46)
CL Item
Left posterior hemiblock (47)
CL Item
Left bundle branch block (48)
CL Item
Bifascicular block (49)
CL Item
Non-specific intraventricular conduction delay (QRS >= 120 msec) (50)
CL Item
Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-Levine) (51)
CL Item
QTc prolongation >=500 msec (52)
CL Item
AV dissociation (53)
CL Item
Myocardial infarction, old (54)
CL Item
Myocardial infarction, non Q-wave (55)
CL Item
Non-specific ST-T changes (56)
CL Item
J point d evation (57)
CL Item
ST elevation (58)
CL Item
ST depression (59)
CL Item
ST segment abnormality (60)
CL Item
U waves (61)
CL Item
T wave inversion (62)
CL Item
T wave peaked (63)
CL Item
T waves biphasic (64)
CL Item
T waves flat (65)
CL Item
Notched T-waves (66)
CL Item
Low QRS voltage (67)
CL Item
T wave abnomality  (68)
CL Item
Other abnormal rhythm (69)
CL Item
Other morphology (70)
CL Item
Other conduction (71)
CL Item
Other myocardial infarction (72)
CL Item
Other depolarisation/repolarisation (73)
CL Item
Other abnormality/Cardiologist comments (74)
morphology
Item
If Other morphology, please specify
text
C0332437 (UMLS CUI [1,1])
C0013801 (UMLS CUI [1,2])
abnormal rhythm
Item
If Other abnormal rhythm, please specify
text
C0232187 (UMLS CUI [1,1])
C0013801 (UMLS CUI [1,2])
conduction
Item
If Other conduction, please specify
text
C0232219 (UMLS CUI [1,1])
C0013801 (UMLS CUI [1,2])
myocardial infarction
Item
If Other myocardial infarction, please specify
text
C0027051 (UMLS CUI [1,1])
C0013801 (UMLS CUI [1,2])
depolarisation/repolarisation
Item
If Other depolarisation/repolarisation, please specify
text
C0948857 (UMLS CUI [1,1])
C0013801 (UMLS CUI [1,2])
Other abnormality Holter ECG
Item
If Other abnormality/Cardiologist comments, please specify
text
C1832603 (UMLS CUI [1,1])
C0013801 (UMLS CUI [1,2])
Item Group
Menstrual cycle profile
C0025329 (UMLS CUI-1)
Date of start of last menstrual period
Item
Date of start of last menstrual period
date
C0425932 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Date of end of last menstrual period
Item
Date of end of last menstrual period
date
C0425932 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Haematology
C0474523 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Haematology sampling date and time
Item
Haematology: Date and time sample taken
datetime
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Fasting
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
Item
Haematology, Type of result
integer
C0474523 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Type of result
Code List
Haematology, Type of result
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
White blood cell count
Item
White blood cell count (WBC)
text
C0023508 (UMLS CUI [1])
Red blood cell count
Item
Red blood cell count (RBC)
text
C0014772 (UMLS CUI [1])
Haemoglobin
Item
Haemoglobin (Hb)
text
C0518015 (UMLS CUI [1])
Haematocrit
Item
Haematocrit (HCT)
text
C0018935 (UMLS CUI [1])
Neutrophil count
Item
Neutrophil count (absolute)
text
C0948762 (UMLS CUI [1])
Lymphocyte count
Item
Lymphocytes
text
C0200635 (UMLS CUI [1])
Monocyte count
Item
Monocytes
text
C0200637 (UMLS CUI [1])
Eosinophil count
Item
Eosinophils
text
C0200638 (UMLS CUI [1])
Basophil count
Item
Basophis
text
C0200641 (UMLS CUI [1])
Platelet count
Item
Platelets
text
C0032181 (UMLS CUI [1])
Reticulocyte count
Item
Reticulocytes
text
C0206161 (UMLS CUI [1])
Mean cell volume
Item
Mean cell volume (MCV)
text
C1948043 (UMLS CUI [1])
Mean cell haemoglobin
Item
Mean cell haemoglobin (MCH)
text
C0369183 (UMLS CUI [1])
Mean cell haemoglobin concentration
Item
Mean cell haemoglobin concentration (MCHC)
text
C0474535 (UMLS CUI [1])
Item Group
Clinical Chemistry
C0008000 (UMLS CUI-1)
Date and time sample taken
Item
Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Fasting
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
Item
Clinical Chemistry, type of result
integer
C0008000 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Type of result
Code List
Clinical Chemistry, type of result
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Alkaline phosphatase
Item
Alkaline phasphatase
text
C0201850 (UMLS CUI [1])
Alanine transaminase
Item
Alanine transaminase
text
C0201836 (UMLS CUI [1])
Total Bilirubin
Item
Total Bilirubin
text
C0201913 (UMLS CUI [1])
Direct Bilirubin
Item
Direct Bilirubin
text
C0201916 (UMLS CUI [1])
Glucose
Item
Glucose
text
C0337438 (UMLS CUI [1])
Gamma-glutamyl transpeptidase
Item
Gamma-glutamyl transpeptidase
text
C0202035 (UMLS CUI [1])
Total protein
Item
Total protein
text
C0555903 (UMLS CUI [1])
Albumin
Item
Albumin
text
C0201838 (UMLS CUI [1])
Potassium
Item
Potassium
text
C0202194 (UMLS CUI [1])
Sodium
Item
Sodium
text
C0337443 (UMLS CUI [1])
Chloride
Item
Chloride
text
C0201952 (UMLS CUI [1])
Urea
Item
Urea
text
C0523961 (UMLS CUI [1])
Creatinine
Item
Creatinine
text
C0201975 (UMLS CUI [1])
Calcium
Item
Calcium
text
C0201925 (UMLS CUI [1])
Bicarbonate
Item
Bicarbonate
text
C0202059 (UMLS CUI [1])
Triglycerides
Item
Triglycerides
text
C0202236 (UMLS CUI [1])
Cholesterol
Item
Cholesterol
text
C0201950 (UMLS CUI [1])
LDL
Item
LDL
text
C0428474 (UMLS CUI [1])
HDL
Item
HDL
text
C0428472 (UMLS CUI [1])
Uric Acid
Item
Uric Acid
text
C0202239 (UMLS CUI [1])
Alkaline Phosphatase
Item
Alkaline Phosphatase
text
C0201850 (UMLS CUI [1])
Item Group
Urinalysis - Local
C0042014 (UMLS CUI-1)
Date sample taken
Item
Date sample taken
date
C0200354 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Time sample taken
Item
Time sample taken
time
C0200354 (UMLS CUI [1,1])
C4064021 (UMLS CUI [1,2])
Item
Result of dipstick
integer
C1160927 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Result of dipstick
Code List
Result of dipstick
CL Item
No result (1)
CL Item
Negative (2)
CL Item
Positive (3)
sedimentary microscopy
Item
If Positive, was sedimentary microscopy performed?
boolean
C2700128 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item Group
Urinalysis - Local: Dipstick Details
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
Item
Urinalysis, Type of result
integer
C0042014 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Type of result
Code List
Urinalysis, Type of result
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Urine Protein
Item
Urine Protein
text
C0430371 (UMLS CUI [1])
Urine Glucose
Item
Urine Glucose
text
C0430376 (UMLS CUI [1])
Urine Ketones
Item
Urine Ketones
text
C0430377 (UMLS CUI [1])
Urine Blood
Item
Urine Blood
text
C0430372 (UMLS CUI [1])
Urine pH
Item
Urine pH
text
C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urine Specific Gravity
Item
Urine Specific Gravity
text
C0202517 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Item Group
Urinalysis - Local: Microscopy Details
C0430397 (UMLS CUI-1)
C0042014 (UMLS CUI-2)
Item
Urinalysis, Type of result
integer
C0042014 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Type of result
Code List
Urinalysis, Type of result
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
White blood cells
Item
White blood cells
text
C0023508 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
Red Blood Cells
Item
Red Blood Cells
text
C0014772 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
Hyaline casts
Item
Hyaline casts
text
C0427894 (UMLS CUI [1])
Cellular casts
Item
Cellular casts
text
C2699157 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
Item Group
Local Laboratory - Clinical Chemistry
C0008000 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Date and time sample taken
Item
Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Fasting
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
Item
Clinical Chemistry, type of result
integer
C0008000 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Type of result
Code List
Clinical Chemistry, type of result
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
TSH
Item
TSH
text
C0202230 (UMLS CUI [1])
GH
Item
GH
text
C0037663 (UMLS CUI [1])
Total Testosterone
Item
Total Testosterone
text
C0202227 (UMLS CUI [1])
Free Testosterone
Item
Free Testosterone
text
C0202228 (UMLS CUI [1])
LH
Item
LH
text
C0202123 (UMLS CUI [1])
FSH
Item
FSH
text
C0202022 (UMLS CUI [1])
Estradiol
Item
Estradiol
text
C0337434 (UMLS CUI [1])
Prolactin
Item
Prolactin
text
C0373706 (UMLS CUI [1])
Item Group
Randomisation
C0034656 (UMLS CUI-1)
Randomisation
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Randomisation number
Item
If Yes, provide randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of randomisation
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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