ID

29852

Descrizione

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

collegamento

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

Keywords

Trial screening

Rezeptoren, Dopamin-D3-

Klinische Studie [Dokumenttyp]

D019966

24/04/18 24/04/18 -
30/04/18 30/04/18 -

Titolare del copyright

GlaxoSmithKline

Caricato su

24 aprile 2018

DOI

Per favore, per richiedere un accesso.

Licenza

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

model
Dettagli

Screening

1 moduli

StudyEvent: ODM
1. Screening

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Date of Visit

Item Group

Date of Visit

C1320303 (UMLS CUI-1)

Date of Visit

Item

Date of Visit

date

C1320303 (UMLS CUI [1])

Demography

Item Group

Demography

C0011298 (UMLS CUI-1)

Date of Birth

Item

Date of Birth

date

C0421451 (UMLS CUI [1])

Gender

Item

Gender

integer

C0079399 (UMLS CUI [1])

Gender

Code List

Gender

CL Item

Female (2)

CL Item

Male (1)

Childbearing potential

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)

Ethnicity

Item

Ethnicity

integer

C0015031 (UMLS CUI [1])

Race

Code List

Ethnicity

CL Item

Hispanic or Latino (1)

CL Item

Not Hispanic or Latino (2)

Geographic ancestry

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)

Cohort

Item Group

Cohort

C0599755 (UMLS CUI-1)
C0008976 (UMLS CUI-2)

Cohort

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)

Vital Signs

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])

Position

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])

12-lead ECG

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])

Method of QTC Measurement

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])

Result of the ECG

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)

Eligibility Question

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])

Subject Identification

Item Group

Subject Identification

C2348585 (UMLS CUI-1)

Subject number

Item

Subject number

text

C2348585 (UMLS CUI [1])

Holter ECG Results

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])

Interpretation of Holter ECG

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)

Holter ECG Abnormalities

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])

Menstrual cycle profile

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])

Haematology

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])

Type of result

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])

Clinical Chemistry

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])

Type of result

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])

Urinalysis - Local

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])

Result of dipstick

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])

Urinalysis - Local: Dipstick Details

Item Group

Urinalysis - Local: Dipstick Details

C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
C0022885 (UMLS CUI-3)

Type of result

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])

Urinalysis - Local: Microscopy Details

Item Group

Urinalysis - Local: Microscopy Details

C0430397 (UMLS CUI-1)
C0042014 (UMLS CUI-2)

Type of result

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])

Local Laboratory - Clinical Chemistry

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])

Type of result

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])

Item

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])

Item

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])

Randomisation

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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Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061

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