ID

33308

Beschreibung

Study ID: 106181 Clinical Study ID: B2C106181 Study Title: An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01286831 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: vilanterol Trade Name: Study Indication: Pulmonary Disease, Chronic Obstructive

Stichworte

Versionen (6)
  1. 09.10.18 09.10.18 -
  2. 10.10.18 10.10.18 -
  3. 10.10.18 10.10.18 -
  4. 10.10.18 10.10.18 -
  5. 05.12.18 05.12.18 -
  6. 17.09.21 17.09.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

5. Dezember 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181

Englisch

Screening visit

1 Formulare  
  1. StudyEvent: ODM
    1. Screening visit
Demography
Beschreibung

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Beschreibung

Patient date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beschreibung

✓ one

Datentyp

text

Alias
UMLS CUI [1]
C0015031
Geographic ancestry
Beschreibung

✓ all that apply

Datentyp

text

Alias
UMLS CUI [1]
C3841890
Vital signs
Beschreibung

Vital signs

Alias
UMLS CUI-1
C0518766
Height
Beschreibung

Body Height

Datentyp

integer

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

Body Weight

Datentyp

float

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

Body mass index

Datentyp

float

Maßeinheiten
  • kg / m2
Alias
UMLS CUI [1]
C1305855
kg / m2
Date
Beschreibung

Vital Signs Date

Datentyp

text

Alias
UMLS CUI [1]
C2826644
Planned relative time
Beschreibung

Vital Signs, Relative time

Datentyp

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
Actual Time
Beschreibung

Vital Signs Time

Datentyp

time

Alias
UMLS CUI [1]
C2826762
Blood Pressure Supine - Systolic
Beschreibung

Systolic Pressure, Supine Position

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Blood Pressure Supine - Diastolic
Beschreibung

Diastolic Blood Pressure, Supine Position

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Heart Rate
Beschreibung

Heart Rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Temperature Oral
Beschreibung

Body Temperature, Oral

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0442027
°C
12-lead ECG
Beschreibung

12-lead ECG

Alias
UMLS CUI-1
C0430456
ECG Number
Beschreibung

12-lead ECG, Numbers

Datentyp

integer

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

12lead ECG, Start Date

Datentyp

date

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

12 lead ECG, Relative time

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439564
Start Time of ECG
Beschreibung

12 lead ECG, Start time

Datentyp

time

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

12 lead ECG, Heart Rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
bpm
PR Interval
Beschreibung

12 lead ECG, P-R interval

Datentyp

float

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

12 lead ECG, QRS complex duration

Datentyp

float

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

12 lead ECG, QT Interval

Datentyp

float

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

12 lead ECG, Measurement Method

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1299991
If machine, QTcB interval
Beschreibung

12 lead ECG, QTcB - Bazett's Correction Formula

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1882512
msec
If machine, QTcF interval
Beschreibung

12 lead ECG, QTcF Fridericia's Correction Formula

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1882513
msec
If machine, QTc interval unknown method of correction
Beschreibung

12 lead ECG, qtc interval

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0489625
msec
Result of the ECG
Beschreibung

12 lead ECG, Electrocardiogram finding

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0438154
12-Lead ECG Abnormalities
Beschreibung

12-Lead ECG Abnormalities

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1704258
Date of ECG
Beschreibung

12 lead ECG, Date in time

Datentyp

date

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

12 Lead ECG, Time

Datentyp

time

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

12 lead ECG, Abnormality, Electrocardiogram: Rhythm

Datentyp

text

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

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

Datentyp

integer

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

12 lead ECG, Abnormality, Cardiac conduction

Datentyp

integer

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

12 lead ECG, Abnormality, Myocardial Infarction

Datentyp

integer

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

12 lead ECG, Abnormality, Ventricular Depolarisation, Electrocardiogram Repolarisation abnormality

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C1331539
UMLS CUI [1,4]
C0948857
Other abnormalities
Beschreibung

12 lead ECG, Abnormality, Other

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0205394
Summary Holter (12HRS)
Beschreibung

Summary Holter (12HRS)

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C0242482
Start date of Holter
Beschreibung

Holter Electrocardiography, Start Date

Datentyp

date

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

Holter Electrocardiography, Start Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1301880
Stop time of Holter
Beschreibung

Holter Electrocardiography, End Time

Datentyp

time

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

Holter Electrocardiography, EKG finding

Datentyp

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0438154
Holter monitoring method
Beschreibung

Holter Electrocardiography, Test Method

Datentyp

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0871511
Summary Holter Abnormalities
Beschreibung

Summary Holter Abnormalities

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C0242482
UMLS CUI-3
C0522055
Clinically significant abnormalities
Beschreibung

tick all that apply

Datentyp

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0522055
Medical conditions
Beschreibung

Medical conditions

Diagnosis
Beschreibung

Only in the absence of a diagnosis, record the signs and symptoms on separate lines

Datentyp

text

Alias
UMLS CUI [1]
C0011900
Current
Beschreibung

Diagnosis, Current

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0521116
Past
Beschreibung

Diagnosis, Past

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C1444637
UMLS CUI [1,3]
C0521116
Physical Examination
Beschreibung

Physical Examination

Alias
UMLS CUI-1
C0031809
Date of Assessment
Beschreibung

Physical Examination, Assessment Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C2985720
Head
Beschreibung

Physical Examination, Head

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0018670
Eyes
Beschreibung

Physical Examination, Eye

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0015392
Ears
Beschreibung

Physical Examination, Ear structure

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0013443
Nose
Beschreibung

Physical Examination, Nose

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0028429
Throat
Beschreibung

Physical Examination, Pharyngeal structure

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0031354
Skin
Beschreibung

Physical Examination, Skin

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1123023
Thyroid
Beschreibung

Physical Examination, Thyroid Gland

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0040132
Neurological
Beschreibung

Physical Examination, Neurologic Examination

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0027853
Lungs
Beschreibung

Physical Examination, Lung

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024109
Cardiovascular
Beschreibung

Physical Examination, Cardiovascular System

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0007226
Abdomen (Liver and Spleen)
Beschreibung

Physical Examination, Abdomen

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
Lymph Nodes
Beschreibung

Physical Examination, Lymph Nodes

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024204
Extremities
Beschreibung

Physical Examination, Examination of the extremities

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0436150
History of Tobacco Use
Beschreibung

History of Tobacco Use

Alias
UMLS CUI-1
C0841002
What is the subject's history of smoking use?
Beschreibung

History of tobacco use

Datentyp

text

Alias
UMLS CUI [1]
C0841002
When did the subject last smoke?
Beschreibung

Tobacco use, Last, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0011008
Number of pack years?
Beschreibung

Pack Years

Datentyp

float

Alias
UMLS CUI [1]
C1277691
Serology - HIV Screen
Beschreibung

Serology - HIV Screen

Alias
UMLS CUI-1
C0459958
Date sample taken
Beschreibung

HIV screen, Sampling, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0459958
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Alcohol Intake
Beschreibung

Alcohol Intake

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

Alcohol consumption

Datentyp

boolean

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

Alcohol consumption, alcohol units/week

Datentyp

float

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

Drug and Alcohol Screen

Alias
UMLS CUI-1
C0373483
UMLS CUI-2
C0202304
Drug Screen, Ethanol measurement, Date in time, Time
Beschreibung

Drug Screen, Ethanol measurement, Date in time, Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0202304
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Electronically transferred laboratory data - Clinical Chemistry
Beschreibung

Electronically transferred laboratory data - Clinical Chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Planned Relative Time
Beschreibung

Laboratory Procedure; Chemistry, Clinical; Relative Time

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0439564
Date Sample Taken
Beschreibung

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

Datentyp

date

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

Laboratory Procedures; Chemistry, Clinical; Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0040223
Electronically transferred laboratory data - Haematology
Beschreibung

Electronically transferred laboratory data - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0018941
Planned Relative Time
Beschreibung

Laboratory Procedure; Hematologic Tests; Relative Time

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0439564
Date Sample Taken
Beschreibung

Laboratory Procedures; Hematologic Tests; Sampling; Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Beschreibung

Laboratory Procedures; Hematologic Tests; Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0040223
Electronically transferred laboratory data - Urinalysis
Beschreibung

Electronically transferred laboratory data - Urinalysis

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0042014
Planned Relative Time
Beschreibung

Laboratory Procedure; Urinalysis; Relative Time

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C0439564
Date Sample Taken
Beschreibung

Laboratory Procedures; Urinalysis; Sampling; Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Beschreibung

Laboratory Procedures; Urinalysis; Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C0040223
Pharmacokinetics - Blood
Beschreibung

Pharmacokinetics - Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beschreibung

Pharmacokinetic aspects, Blood, Relative time

Datentyp

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0439564
Date Sample Taken
Beschreibung

Pharmacokinetic aspects, Blood, Sampling, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Beschreibung

Pharmacokinetic aspects, Blood, Sampling, Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
Sample Number
Beschreibung

Pharmacokinetic aspects, Blood, Sampling, Numbers

Datentyp

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0237753
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Healthy male aged between 30 and 55 years inclusive, at the time of signing the informed consent. 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 clinical abnormality or laboratory parameters outside the reference range for the population, which are deemed to be clinically relevant, should always be excluded from enrollment.
Beschreibung

Gender, Health Status, Age

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0018759
UMLS CUI [1,3]
C0001779
Body Mass Index (BMI) within the range 18.5-29.0 kg/m2 (inclusive).
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Subjects who are current non-smokers, who have not used any tobacco products in the 12 month period preceding the screening visit, and have a pack history of <= 5 pack years [number of pack years = (number of cigarettes per day/20)x number of years smoked].
Beschreibung

Tobacco use

Datentyp

boolean

Alias
UMLS CUI [1]
C0543414
AST, ALT, alkaline phosphatase and bilirubin < = 1.5xULN (isolated bilirubin>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Beschreibung

Alanine aminotransferase measurement, Aspartate aminotransferase measurement, Alkaline phosphatase measurement, Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C0201899
UMLS CUI [1,3]
C0201850
UMLS CUI [1,4]
C1278039
No significant abnormality on 12-lead ECG at screening. Selected specific ECG findings that are considered to be significant and will exclude the subject from study participation include, but are not limited to, the following: - Sinus tachycardia > = 110 bpm - Multifocal atrial tachycadria (wandering atrial pacemaker with rate >100 bpm) = - Multifocal atrial tachycadria (wandering atrial pacemaker with rate >100 bpm) - PR interval >240 msec = - PR interval >240 msec - Evidence of Mobitz II second degree or third degree atroventricular (AV) block = - Evidence of Mobitz II second degree or third degree atroventricular (AV) block - Pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4mV (4mm with 10mm/mV setting)] or 25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads. Note: prior evidence (i.e., ECG obtained at least 12 month prior) of pathological Q waves that are unchanged are not exclusionary. = - Pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4mV (4mm with 10mm/mV setting)] or 25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads. Note: prior evidence (i.e., ECG obtained at least 12 month prior) of pathological Q waves that are unchanged are not exclusionary. - Evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes. = - Evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes. - QTcF > = 450 msec or uncorrected QT>600 msec or an ECG that is unsuitable for QT measurements (e.g., poor defined termination of the T wave). Note: QTcF>= 450 msec or uncorrected QT>600 msec should be confirmed by three readings at least 5 minutes apart - ST-T wave abnormalities (excluding non-specific ST-T wave abnormalities = - ST-T wave abnormalities (excluding non-specific ST-T wave abnormalities - Right or left complete bundle branch block = - Right or left complete bundle branch block - Clinically significant conduction abnormalities (e.g., atrial fibrilation with rapid ventricular response, ventricular tachycardia = - Clinically significant conduction abnormalities (e.g., atrial fibrilation with rapid ventricular response, ventricular tachycardia
Beschreibung

12 lead ECG, Abnormality

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
No significant abnormality on the Holter ECG at screening
Beschreibung

Holter Electrocardiography, ECG abnormality

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1832603
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
As a result of medical interview, physical examination or screening investigations, the principal investigator or delegate physician deems the subject unsuitable for the study. Subjects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 90 mmHg.
Beschreibung

Unsuitable for study, Blood Pressure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0005823
Females
Beschreibung

Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
The subject has been treated for or diagnosed with depression within six month of screenin or has a history of significant psychiatric illness.
Beschreibung

Depressive disorder, Significant, Mental disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0004936
Current or chronic history of liver disease, or know hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Beschreibung

Liver diseases; Abnormality of the liver; Biliary tract abnormality

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C4021780
UMLS CUI [1,3]
C0549613
Surgical procedures on digestive tract including corrective surgery for appendicitis (in the 3 months prior to screening) or diverticulitis, cholecystectomy (gallbladder removal), and/or cholelithotomy (gallstone removal).
Beschreibung

Operative Surgical Procedures; Gastrointestinal tract structure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0017189
History of current spastic/hyperactive colon.
Beschreibung

spastic colon syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0848327
Subjects who do not have regular defecation patterns (regular defined as passing feces at least once every two days).
Beschreibung

Defecation, irregular

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011135
UMLS CUI [1,2]
C0205271
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contrandicates their participation.
Beschreibung

Experimental Drug, Hypersensitivity; Hypersensitivity, Other

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0020517
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0205394
Any adverse reaction including immediate or delayed hypersensitivity to any ß2 agonist or sympathomimetic drug, or known or suspected sensitivity to the constituents of the GW642444formulation for oral administration.
Beschreibung

Adrenergic beta2-Agonists [MoA], Hypersensitivity; Amines, Sympathomimetic, Hypersensitivity; Experimental drug, Hypersensitivity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1373132
UMLS CUI [1,2]
C0020517
UMLS CUI [2,1]
C0002509
UMLS CUI [2,2]
C0020517
UMLS CUI [3,1]
C0304229
UMLS CUI [3,2]
C0020517
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if a drug is a potential enzyme inducer) or 5 half-lives (whichever if 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 of compromise subject safety.
Beschreibung

Pharmaceutic Preparations; Vitamins, Herbal supplements, Dietary Supplements

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0042890
UMLS CUI [1,3]
C1504473
UMLS CUI [1,4]
C0242295
History of alcohol/drug abuse or dependence within 12 month of the study. Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males). One unit is equivalent to a 285 mL glass of full strength beer or 425 mL schooner of light beer or 1 (30 mL) measure of spirits or 1 glass (100 mL) of wine (NHMRC Guidelines [NHMRC,2001]).
Beschreibung

alcohol abuse; Drug abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0013146
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: 60 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
Exposure to more than four new chemical entities within 12 month prior to the first dosing day.
Beschreibung

Pharmaceutical Preparations, Exposure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332157
Participation in a clinical trial involving administration of 14C-labelled compound(s) withing the last 12 month. A subject's previous effective dose will be reviewed by the medical investigator to ensure there is no risk of contamination/carryover into the current study.
Beschreibung

Compound, Labeled, Carbon-14

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1706082
UMLS CUI [1,2]
C1708632
UMLS CUI [1,3]
C0302945
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

Blood Donation; Blood product

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0456388
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
Beschreibung

Hepatitis B surface antigen positive; Hepatitis C antibody positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0149709
UMLS CUI [1,2]
C0281863
The subject has tested positive for HIV antibodies.
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
A positive urine drug screen at screening, on admission to the unnit, or when randomly tested during the study.
Beschreibung

Urine drug screen positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0743300
Positive alcohol urine test at screening or on admission to the Unit.
Beschreibung

Urine drug screen positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0743300
Positive urine cotinine test at screening.
Beschreibung

Urine cotinine test

Datentyp

boolean

Alias
UMLS CUI [1]
C1697737
Consumption of seville oranges, pomelos (members of the grapefruit family) or grapefruit juice from 7 days prior to the first dose of study medication.
Beschreibung

Grapefruit, Grapefruit Juice

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0995150
UMLS CUI [1,2]
C0452456
Unwillingness or inability to follow the procedures outlined in the protocol.
Beschreibung

Compliance behavior

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
Subject is mentally or legally incapacitated.
Beschreibung

Mental Handicap; Legal Capacity, Lacking

Datentyp

boolean

Alias
UMLS CUI [1]
C1306341
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0332268
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Ähnliche Modelle

Screening visit

1 Formulare
  1. StudyEvent: ODM
    1. Screening visit
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
Sex
Code List
Sex
CL Item
male (1)
CL Item
female (2)
Item
Ethnicity
text
C0015031 (UMLS CUI [1])
Ethnicity ✓ one
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Geographic ancestry
text
C3841890 (UMLS CUI [1])
Geographic ancestry ✓ all that apply
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])
Item
Date
text
C2826644 (UMLS CUI [1])
Date
Code List
Date
CL Item
1. (1)
CL Item
2. (2)
CL Item
3. (3)
Item
Planned relative time
text
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Planned relative time
Code List
Planned relative time
CL Item
screening (1)
CL Item
unscheduled (2)
CL Item
unscheduled (3)
Vital Signs Time
Item
Actual Time
time
C2826762 (UMLS CUI [1])
Systolic Pressure, Supine Position
Item
Blood Pressure Supine - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic Blood Pressure, Supine Position
Item
Blood Pressure Supine - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Body Temperature, Oral
Item
Temperature Oral
float
C0005903 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
Item Group
12-lead ECG
C0430456 (UMLS CUI-1)
Item
ECG Number
integer
C0430456 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Timepoint of ECG
Code List
ECG Number
CL Item
ECG one (1)
CL Item
ECG two (2)
CL Item
ECG three (3)
12lead ECG, Start Date
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Planned Relative Time ECG
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
12 lead ECG, Relative time
Code List
Planned Relative Time ECG
CL Item
Screening (1)
CL Item
Unscheduled (2)
CL Item
Unscheduled (3)
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, P-R interval
Item
PR Interval
float
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
12 lead ECG, QRS complex duration
Item
QRS Duration
float
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
12 lead ECG, QT Interval
Item
Uncorrected QT Interval
float
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
Item
Method of measurement
integer
C0430456 (UMLS CUI [1,1])
C1299991 (UMLS CUI [1,2])
12 lead ECG, Measurement Method
Code List
Method of measurement
CL Item
Machine (1)
CL Item
Manual (2)
12 lead ECG, QTcB - Bazett's Correction Formula
Item
If machine, QTcB interval
integer
C0430456 (UMLS CUI [1,1])
C1882512 (UMLS CUI [1,2])
12 lead ECG, QTcF Fridericia's Correction Formula
Item
If machine, QTcF interval
integer
C0430456 (UMLS CUI [1,1])
C1882513 (UMLS CUI [1,2])
12 lead ECG, qtc interval
Item
If machine, QTc interval unknown method of correction
integer
C0430456 (UMLS CUI [1,1])
C0489625 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0430456 (UMLS CUI [1,1])
C0438154 (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)
CL Item
No result (not available) (4)
Item Group
12-Lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-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])
Rhythm
Code List
Rhythm
CL Item
[A23] Sinus bradycardia (heart rate < 30 beats/min) (4)
CL Item
[A 3] Sinus pause (5)
CL Item
[A 2] Sinus tachycardia (6)
CL Item
[A 4] Ectropic supraventricular beats (7)
CL Item
[A20] Ectropic supraventricular rythm (8)
CL Item
[A17] Wandering atrial pacemaker (9)
CL Item
[A26] Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate > 100 beats/min) (10)
CL Item
[A 6] Supraventricular tachycardia (Heart rate > 100 beats/min) (11)
CL Item
[A 7] Atrial flutter (12)
CL Item
[A 8] Atrial fibrillation (13)
CL Item
[A 5] Junctional rhythm (heart rate <100 beats/min) (14)
CL Item
[A25] Junctional rhythm (15)
CL Item
[A24] Junctional tachycardia (heart rate > 100 beats/min) (16)
CL Item
[A 9] Ectopic ventricular beats (17)
CL Item
[A 1] Sinus bradycardia (1)
CL Item
[A21] Sinus bradycardia (heart rate 40-50 beats/min) (2)
CL Item
[A22] Sinus bradycardia (heart rate 30-39 beats/min) (3)
Item
P-Wave and QRS Morphology
integer
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
C0429098 (UMLS CUI [1,4])
P-Wave and QRS Morphology
Code List
P-Wave and QRS Morphology
CL Item
[B 3] right ventricular hypertrophy (1)
CL Item
[B 5] Intraatrial conduction delay (2)
CL Item
[B 7] Poor R wave progression (3)
CL Item
[B 9] Left atrial abnormality (4)
CL Item
[B10] Right atrial abnormality (5)
CL Item
[A12] Ventricular couplets (6)
CL Item
[A13] Bigeminy (7)
CL Item
[A28] Trigeminy (8)
CL Item
[A14] Electrical alternans (9)
CL Item
[A29] R on T phenomenon (10)
CL Item
[A18] Ventricular vebrilation (11)
CL Item
[A19] Indioventricular rhythm (heart rate < 100 bpm) (12)
CL Item
[A10] Sustained ventricular tachycardia (13)
CL Item
[A11] Non-sustained ventricular tachycardia  (14)
CL Item
[A33] Sinus arrhythmia  (15)
CL Item
[A33] Sinus arrhythmia  (15)
CL Item
[A27] Ventricular tachycardia  (16)
CL Item
[A30] Monomorphic ventricular tachycardia  (17)
CL Item
[A15] Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (18)
CL Item
[A31] Polymorphic (sustained and non-sustained) ventricular tachycardia (19)
CL Item
[A16] Artificial pacemaker  (20)
CL Item
[A35] Atrial premature complex (21)
CL Item
[A99]Other abnormal rhythm  (22)
CL Item
[B16] Late R wave transition (23)
CL Item
[D14] Increased voltage consistent with left ventricular hypertrophy (24)
CL Item
[B99] Other morphology (25)
Item
Conduction
integer
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
C. Conduction
Code List
Conduction
CL Item
[C 1] First degree AV block (PR interval > 200 msec) (1)
CL Item
[C20] Short PR interval (2)
CL Item
[C 2] Second degree AV block (Mobitz type 1) (3)
CL Item
[C 3] Second degree AV block (Mobitz type 2) (4)
CL Item
[C16] 2:1 AV block  (5)
CL Item
[C 4] Third degree AV block (6)
CL Item
[C 5] Left axis deviation (QRS axis more negative than -30°) (7)
CL Item
[C 6] Right axis deviation (QRS axis more positive than +110°) (8)
CL Item
[C 7] Incomplete right bundle branch block (9)
CL Item
[C13] Incomplete left bundle branch block (10)
CL Item
[C 8] Right bundle branch block  (11)
CL Item
[C 14] Left anterior hemiblock (synonymous to left anterior fascicular block) (12)
Item
Myocardial Infarction
integer
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
D. Myocardial Infraction
Code List
Myocardial Infarction
CL Item
[D 1] Myocardial infarction, old (1)
CL Item
[D 2] Myocardial infarction, anterior (2)
CL Item
[D 3] Myocardial infarction, lateral (3)
CL Item
[D 4] Myocardial infarction, posterior (4)
CL Item
[D 5] Myocardial infarction, inferior (5)
Item
Depolarisation/Repolarisation (QRS-T)
integer
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0948857 (UMLS CUI [1,4])
E. Depolarisation/Repolarisation (QRS-T)
Code List
Depolarisation/Repolarisation (QRS-T)
CL Item
[D 7] Non-specific ST-T changes (1)
CL Item
[D19] J point elevation (2)
CL Item
[D 8] ST elevation (3)
CL Item
[D21] ST elevation-pericarditis (4)
CL Item
[D 9] ST depression (5)
CL Item
[D96] ST segment abnormality, not specified (6)
CL Item
[D10] U waves abnormal (7)
CL Item
[D11] T wave inversion (8)
CL Item
[D12] T wave peaked (9)
Item
Other abnormalities
integer
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Other abnormalities
Code List
Other abnormalities
CL Item
[E99] Other abnormalities (1)
CL Item
[C15] Left posterior hemiblock (synonymous to left posterior fascicular block) (2)
CL Item
[C 9] Left bundle branch block  (3)
CL Item
[C17] Bifascicular block (4)
CL Item
[C10] Non-specific intraventricular conduction delay (QRS>120msec) (5)
CL Item
[C11] Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (6)
CL Item
[C18] AV dissociation  (7)
CL Item
[C28] Prolonged QT 450-500 (8)
CL Item
[C29] Prolonged QT >500 (9)
CL Item
[C30] Prolonged QTc Interval 450-500 (10)
CL Item
[C31] Prolonged QTc Interval >500 (11)
CL Item
[C99] Other conduction (12)
CL Item
[D 6] Myocardial infraction, septal (13)
CL Item
[D20] Myocardial infraction, Non-Q wave (14)
CL Item
[D08] Other myocardial infraction (15)
CL Item
[D15] T waves flat (16)
CL Item
[D16] T waves biphasic (17)
CL Item
[D18] Notched T-waves (18)
CL Item
[D13] Low QRS voltage (19)
CL Item
[D17] T-wave flattening/inversion (20)
CL Item
[D22] Juvenile T wave pattern, early repolarization (21)
CL Item
[D97] T wave abnormality, not specified (22)
CL Item
[D99] Other depolarization/repolarization (23)
Item Group
Summary Holter (12HRS)
C0013801 (UMLS CUI-1)
C0242482 (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, Start Time
Item
Start time of Holter
time
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
Interpretation of Holter
text
C0013801 (UMLS CUI [1,1])
C0438154 (UMLS CUI [1,2])
Interpretation of Holter tick one
Code List
Interpretation of Holter
CL Item
[1] Normal (1)
CL Item
[2] Abnormal - Not clinically significant (2)
CL Item
[3] Abnormal - Clinically significant (3)
CL Item
[4] No result (4)
CL Item
[8] Unable to evaluate (5)
Item
Holter monitoring method
text
C0013801 (UMLS CUI [1,1])
C0871511 (UMLS CUI [1,2])
Holter monitoring method tick one
Code List
Holter monitoring method
CL Item
[1] 12 Lead 1000Hz (1)
CL Item
[2] 12 Lead 180 Hz (2)
CL Item
[3] 3 Lead 180 Hz (3)
CL Item
[4] Telemetry (4)
CL Item
[5] 5 Lead 512Hz (5)
CL Item
[6] 4 Lead 0.05-40 Hz (6)
CL Item
[7] 6 Lead 0.05-40 Hz (7)
CL Item
[8] 7 Lead 0.05-100 Hz-3dB (8)
CL Item
[9] 7 Lead 3 channel 133 Hz (9)
CL Item
[10] 2 lead 200 Hz (10)
CL Item
[OT] Other (11)
Item Group
Summary Holter Abnormalities
C0013801 (UMLS CUI-1)
C0242482 (UMLS CUI-2)
C0522055 (UMLS CUI-3)
Item
Clinically significant abnormalities
text
C0013801 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
Clinically significant abnormalities
Code List
Clinically significant abnormalities
CL Item
[A01] Sinus bradycardia (50-59 bpm) (1)
CL Item
[A02] Sinus bradycardia (40-49 bpm) (2)
CL Item
[A03] Sinus bradycardia (30-39 bpm) (3)
CL Item
[A04] Sinus bradycardia (<30 bpm) (4)
CL Item
[A05] Sinus pause (5)
CL Item
[A06] Sinus tachycardia (6)
CL Item
[A07] Ectopic supraventricular beats (7)
CL Item
[A08] Ectopic supraventricular rhythm  (8)
CL Item
[A09] Wandering atrial pacemaker (9)
CL Item
[A10] Multifocal atrial tachycardia (wandering atrial pacemaker w/rate>100 bpm) (10)
CL Item
[A11] Non-sustained supraventricular tachycardia (>100 bpm. >30 beats) (11)
CL Item
[A12] Sustained supraventricular tachycardia (>100 bpm. >30 beats) (12)
CL Item
[A13] Atrial flutter (13)
CL Item
[A14] Atrial fibrillation (14)
CL Item
[A15] Junctional rhythm (<=100 bpm, defined by narrow QRS complexes) (15)
CL Item
[A16] Junctional tachycardia (heart rate > 100 bpm) (16)
CL Item
[A17] Ventricular premature depolarisation (17)
CL Item
[A18] Ventricular couplets (18)
CL Item
[A19] Bigeminy (19)
CL Item
[A20] Trigeminy (20)
CL Item
[A21] Electrical alternans (21)
CL Item
[A22] R on T phenomenon (22)
CL Item
[A23] Ventricular febrillation (23)
CL Item
[A24] Idioventricular rhathm (<=100 bpm, defined by wide QRS complexes) (24)
CL Item
[A25] Non-sustained ventricular tachycardia (>100 bpm, 3-30 beats) (25)
CL Item
[A26] Sustained ventricular tachycardia (>100 bpm, >30 beats) (26)
CL Item
[A27] Wide QRS Tachycardia (diagnosis unknown) (27)
CL Item
[A28] Monomorphic non-sustained ventricular tachycardia (>100 bpm, 3-30 beats)  (28)
CL Item
[A29] Monomorphic non-sustained ventricular tachycardia (>100 bpm, >30 beats) (29)
CL Item
[A30] Polymorphic non-sustained ventricular tachycardia (>100 bpm, 3-30 bpm)  (30)
CL Item
[A31] Polymorphic non-sustained ventricular tachycardia (>100 bpm, >30 bpm)  (31)
CL Item
[A32] Torsade de Pointes (TdP)  (32)
CL Item
[A33] Pacemaker  (33)
CL Item
[A34] First degree AV block (PR interval >200msec) (34)
CL Item
[A35] Short PR Interval  (35)
CL Item
[A36] Second degree AV block (Mobitz type 1) (36)
CL Item
[A37] Second degree AV block (Mobitz type 2) (37)
CL Item
[A38] 2:1 AV block  (38)
CL Item
[A39] Third degree AV block  (39)
CL Item
[A40] Left axis deviation (QRS axis more negative than -30 degrees)  (40)
CL Item
[A41] Right axis deviation (QRS axis more positive than +110 degrees) (41)
CL Item
[A42] Incomplete right bundle branch block (42)
CL Item
[A43] Incomplete left bundle branch block (43)
CL Item
[A44] Right bundle branch block (44)
CL Item
[A45] Left anterior hemiblock (45)
CL Item
[A46] Left posterior hemiblock  (46)
CL Item
[A47] Left bundle branch block (47)
CL Item
[A48] Bifascicular block (48)
CL Item
[A49] Non-specific intraventricular conduction delay (QRS>=120 msec) (49)
CL Item
[A50] Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-Levine) (50)
CL Item
[A51] QTc prolongation >=500 msec (51)
CL Item
[A52] AV dissociation  (52)
CL Item
[A53] Myocardial infraction, old (53)
CL Item
[A54] Myocardial infraction, non Q-wave (54)
CL Item
[A55] Non-specific ST-T changes (55)
CL Item
[A56] J point elevation (56)
CL Item
[A57] ST elevation (57)
CL Item
[A58] ST depression (58)
CL Item
[A59] ST segment abnormality (59)
CL Item
[A60] U waves (60)
CL Item
[A61] T wave inversion (61)
CL Item
[A62] T wave peaked (62)
CL Item
[A63] T waves byphasic (63)
CL Item
[A64] T waves flat (64)
CL Item
[A65] Notched T-waves (65)
CL Item
[A66] Low QRS voltage (66)
CL Item
[A67] T wave abnormality (67)
CL Item
[A94] Other abnormal rhythm (68)
CL Item
[A95] Other morphology (69)
CL Item
___________________________________________ (___________________________________________)
CL Item
[A96] Other conduction (70)
CL Item
___________________________________________ (___________________________________________)
CL Item
[A97] Other myocardial infraction (71)
CL Item
___________________________________________ (___________________________________________)
CL Item
[A98] Other depolarisation/repolarisation (72)
CL Item
___________________________________________ (___________________________________________)
CL Item
[A99] Other abnormality/Cardiologist comments (73)
CL Item
___________________________________________ (___________________________________________)
Item Group
Medical conditions
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Diagnosis, Current
Item
Current
boolean
C0011900 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Diagnosis, Past
Item
Past
boolean
C0011900 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
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
Head
text
C0031809 (UMLS CUI [1,1])
C0018670 (UMLS CUI [1,2])
1. Head
Code List
Head
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Eyes
text
C0031809 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
2. Eyes
Code List
Eyes
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Ears
text
C0031809 (UMLS CUI [1,1])
C0013443 (UMLS CUI [1,2])
3. Ears
Code List
Ears
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Nose
text
C0031809 (UMLS CUI [1,1])
C0028429 (UMLS CUI [1,2])
4. Nose
Code List
Nose
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Throat
text
C0031809 (UMLS CUI [1,1])
C0031354 (UMLS CUI [1,2])
5. Throat
Code List
Throat
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Skin
text
C0031809 (UMLS CUI [1,1])
C1123023 (UMLS CUI [1,2])
6. Skin
Code List
Skin
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Thyroid
text
C0031809 (UMLS CUI [1,1])
C0040132 (UMLS CUI [1,2])
7. Thyroid
Code List
Thyroid
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Neurological
text
C0031809 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
8. Neurological
Code List
Neurological
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Lungs
text
C0031809 (UMLS CUI [1,1])
C0024109 (UMLS CUI [1,2])
9. Lungs
Code List
Lungs
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Cardiovascular
text
C0031809 (UMLS CUI [1,1])
C0007226 (UMLS CUI [1,2])
10. Cardiovascular
Code List
Cardiovascular
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Abdomen (Liver and Spleen)
text
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
11. Abdomen (Liver and Spleen)
Code List
Abdomen (Liver and Spleen)
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Lymph Nodes
text
C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
12. Lymph Nodes
Code List
Lymph Nodes
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Extremities
text
C0031809 (UMLS CUI [1,1])
C0436150 (UMLS CUI [1,2])
13. Extremities
Code List
Extremities
CL Item
Normal (1)
CL Item
Abnormal (2)
Item Group
History of Tobacco Use
C0841002 (UMLS CUI-1)
Item
What is the subject's history of smoking use?
text
C0841002 (UMLS CUI [1])
History of tobacco use
Code List
What is the subject's history of smoking use?
CL Item
Never smoked (1)
CL Item
Former smoker (2)
Tobacco use, Last, Date in time
Item
When did the subject last smoke?
date
C0543414 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Pack Years
Item
Number of pack years?
float
C1277691 (UMLS CUI [1])
Item Group
Serology - HIV Screen
C0459958 (UMLS CUI-1)
HIV screen, Sampling, Date in time
Item
Date sample taken
date
C0459958 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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
float
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Item Group
Drug and Alcohol Screen
C0373483 (UMLS CUI-1)
C0202304 (UMLS CUI-2)
Drug Screen, Ethanol measurement, Date in time, Time
Item
datetime
C0373483 (UMLS CUI [1,1])
C0202304 (UMLS CUI [1,2])
C0011008 (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)
Item
Planned Relative Time
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Laboratory Procedure; Chemistry, Clinical; Relative Time
Code List
Planned Relative Time
CL Item
Screening (Screening)
CL Item
Unscheduled (Unscheduled)
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; Time
Item
Actual Time
time
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Electronically transferred laboratory data - Haematology
C0022885 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Item
Planned Relative Time
text
C0022885 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Laboratory Procedure; Chemistry, Clinical; Relative Time
Code List
Planned Relative Time
CL Item
Screening (Screening)
CL Item
Unscheduled (Unscheduled)
Laboratory Procedures; Hematologic Tests; Sampling; Date in time
Item
Date Sample Taken
date
C0022885 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures; Hematologic Tests; Time
Item
Actual Time
time
C0022885 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Electronically transferred laboratory data - Urinalysis
C0022885 (UMLS CUI-1)
C0042014 (UMLS CUI-2)
Item
Planned Relative Time
text
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Laboratory Procedure; Chemistry, Clinical; Relative Time
Code List
Planned Relative Time
CL Item
Screening (Screening)
CL Item
Unscheduled (Unscheduled)
Laboratory Procedures; Urinalysis; Sampling; Date in time
Item
Date Sample Taken
date
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures; Urinalysis; Time
Item
Actual Time
time
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Pharmacokinetics - Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
text
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Pharmacokinetic aspects, Blood, Relative time
Code List
Planned Relative Time
CL Item
Screening (1)
CL Item
Unscheduled (2)
CL Item
Unscheduled (3)
Pharmacokinetic aspects, Blood, Sampling, Date in time
Item
Date Sample Taken
date
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Pharmacokinetic aspects, Blood, Sampling, Time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Pharmacokinetic aspects, Blood, Sampling, Numbers
Item
Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Gender, Health Status, Age
Item
Healthy male aged between 30 and 55 years inclusive, at the time of signing the informed consent. 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 clinical abnormality or laboratory parameters outside the reference range for the population, which are deemed to be clinically relevant, should always be excluded from enrollment.
boolean
C0079399 (UMLS CUI [1,1])
C0018759 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,3])
Body mass index
Item
Body Mass Index (BMI) within the range 18.5-29.0 kg/m2 (inclusive).
boolean
C1305855 (UMLS CUI [1])
Tobacco use
Item
Subjects who are current non-smokers, who have not used any tobacco products in the 12 month period preceding the screening visit, and have a pack history of <= 5 pack years [number of pack years = (number of cigarettes per day/20)x number of years smoked].
boolean
C0543414 (UMLS CUI [1])
Alanine aminotransferase measurement, Aspartate aminotransferase measurement, Alkaline phosphatase measurement, Serum total bilirubin measurement
Item
AST, ALT, alkaline phosphatase and bilirubin < = 1.5xULN (isolated bilirubin>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
boolean
C0201836 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
C0201850 (UMLS CUI [1,3])
C1278039 (UMLS CUI [1,4])
12 lead ECG, Abnormality
Item
No significant abnormality on 12-lead ECG at screening. Selected specific ECG findings that are considered to be significant and will exclude the subject from study participation include, but are not limited to, the following: - Sinus tachycardia > = 110 bpm - Multifocal atrial tachycadria (wandering atrial pacemaker with rate >100 bpm) = - Multifocal atrial tachycadria (wandering atrial pacemaker with rate >100 bpm) - PR interval >240 msec = - PR interval >240 msec - Evidence of Mobitz II second degree or third degree atroventricular (AV) block = - Evidence of Mobitz II second degree or third degree atroventricular (AV) block - Pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4mV (4mm with 10mm/mV setting)] or 25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads. Note: prior evidence (i.e., ECG obtained at least 12 month prior) of pathological Q waves that are unchanged are not exclusionary. = - Pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4mV (4mm with 10mm/mV setting)] or 25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads. Note: prior evidence (i.e., ECG obtained at least 12 month prior) of pathological Q waves that are unchanged are not exclusionary. - Evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes. = - Evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes. - QTcF > = 450 msec or uncorrected QT>600 msec or an ECG that is unsuitable for QT measurements (e.g., poor defined termination of the T wave). Note: QTcF>= 450 msec or uncorrected QT>600 msec should be confirmed by three readings at least 5 minutes apart - ST-T wave abnormalities (excluding non-specific ST-T wave abnormalities = - ST-T wave abnormalities (excluding non-specific ST-T wave abnormalities - Right or left complete bundle branch block = - Right or left complete bundle branch block - Clinically significant conduction abnormalities (e.g., atrial fibrilation with rapid ventricular response, ventricular tachycardia = - Clinically significant conduction abnormalities (e.g., atrial fibrilation with rapid ventricular response, ventricular tachycardia
boolean
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Holter Electrocardiography, ECG abnormality
Item
No significant abnormality on the Holter ECG at screening
boolean
C0013801 (UMLS CUI [1,1])
C1832603 (UMLS CUI [1,2])
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])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Unsuitable for study, Blood Pressure
Item
As a result of medical interview, physical examination or screening investigations, the principal investigator or delegate physician deems the subject unsuitable for the study. Subjects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 90 mmHg.
boolean
C2348568 (UMLS CUI [1,1])
C0005823 (UMLS CUI [1,2])
Gender
Item
Females
boolean
C0079399 (UMLS CUI [1])
Depressive disorder, Significant, Mental disorders
Item
The subject has been treated for or diagnosed with depression within six month of screenin or has a history of significant psychiatric illness.
boolean
C0011581 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
Liver diseases; Abnormality of the liver; Biliary tract abnormality
Item
Current or chronic history of liver disease, or know hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
boolean
C0023895 (UMLS CUI [1,1])
C4021780 (UMLS CUI [1,2])
C0549613 (UMLS CUI [1,3])
Operative Surgical Procedures; Gastrointestinal tract structure
Item
Surgical procedures on digestive tract including corrective surgery for appendicitis (in the 3 months prior to screening) or diverticulitis, cholecystectomy (gallbladder removal), and/or cholelithotomy (gallstone removal).
boolean
C0543467 (UMLS CUI [1,1])
C0017189 (UMLS CUI [1,2])
spastic colon syndrome
Item
History of current spastic/hyperactive colon.
boolean
C0848327 (UMLS CUI [1])
Defecation, irregular
Item
Subjects who do not have regular defecation patterns (regular defined as passing feces at least once every two days).
boolean
C0011135 (UMLS CUI [1,1])
C0205271 (UMLS CUI [1,2])
Experimental Drug, Hypersensitivity; Hypersensitivity, Other
Item
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contrandicates their participation.
boolean
C0304229 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Adrenergic beta2-Agonists [MoA], Hypersensitivity; Amines, Sympathomimetic, Hypersensitivity; Experimental drug, Hypersensitivity
Item
Any adverse reaction including immediate or delayed hypersensitivity to any ß2 agonist or sympathomimetic drug, or known or suspected sensitivity to the constituents of the GW642444formulation for oral administration.
boolean
C1373132 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0002509 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3,1])
C0020517 (UMLS CUI [3,2])
Pharmaceutic Preparations; Vitamins, Herbal supplements, Dietary Supplements
Item
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if a drug is a potential enzyme inducer) or 5 half-lives (whichever if 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 of compromise subject safety.
boolean
C0013227 (UMLS CUI [1,1])
C0042890 (UMLS CUI [1,2])
C1504473 (UMLS CUI [1,3])
C0242295 (UMLS CUI [1,4])
alcohol abuse; Drug abuse
Item
History of alcohol/drug abuse or dependence within 12 month of the study. Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males). One unit is equivalent to a 285 mL glass of full strength beer or 425 mL schooner of light beer or 1 (30 mL) measure of spirits or 1 glass (100 mL) of wine (NHMRC Guidelines [NHMRC,2001]).
boolean
C0085762 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
Study Subject Participation Status
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: 60 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
boolean
C2348568 (UMLS CUI [1])
Pharmaceutical Preparations, Exposure
Item
Exposure to more than four new chemical entities within 12 month prior to the first dosing day.
boolean
C0013227 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
Compound, Labeled, Carbon-14
Item
Participation in a clinical trial involving administration of 14C-labelled compound(s) withing the last 12 month. A subject's previous effective dose will be reviewed by the medical investigator to ensure there is no risk of contamination/carryover into the current study.
boolean
C1706082 (UMLS CUI [1,1])
C1708632 (UMLS CUI [1,2])
C0302945 (UMLS CUI [1,3])
Blood Donation; Blood product
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
C0005794 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
Hepatitis B surface antigen positive; Hepatitis C antibody positive
Item
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
boolean
C0149709 (UMLS CUI [1,1])
C0281863 (UMLS CUI [1,2])
HIV Seropositivity
Item
The subject has tested positive for HIV antibodies.
boolean
C0019699 (UMLS CUI [1])
Urine drug screen positive
Item
A positive urine drug screen at screening, on admission to the unnit, or when randomly tested during the study.
boolean
C0743300 (UMLS CUI [1])
Urine drug screen positive
Item
Positive alcohol urine test at screening or on admission to the Unit.
boolean
C0743300 (UMLS CUI [1])
Urine cotinine test
Item
Positive urine cotinine test at screening.
boolean
C1697737 (UMLS CUI [1])
Grapefruit, Grapefruit Juice
Item
Consumption of seville oranges, pomelos (members of the grapefruit family) or grapefruit juice from 7 days prior to the first dose of study medication.
boolean
C0995150 (UMLS CUI [1,1])
C0452456 (UMLS CUI [1,2])
Compliance behavior
Item
Unwillingness or inability to follow the procedures outlined in the protocol.
boolean
C1321605 (UMLS CUI [1])
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])
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