ID

41641

Description

Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

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Versions (1)
  1. 30/11/2020 30/11/2020 -
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GlaxoSmithKline

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30 novembre 2020

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Creative Commons BY 4.0
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Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673

Anglais

Screening - Summary Holter; Holter Abnormalities

1 Formulaires  
Summary Holter
Description

Summary Holter

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C0242482
Sart Date and Time of Holter
Description

Sart Date and Time of Holter

Type de données

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C0013801
UMLS CUI [2,2]
C1301880
Stop Date and Time of Holter
Description

Stop Date and Time of Holter

Type de données

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C0013801
UMLS CUI [2,2]
C1522314
Maximum heart rate
Description

Maximum heart rate

Type de données

integer

Unités de mesure
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0806909
beats/min
Minimum heart rate
Description

Minimum heart rate

Type de données

integer

Unités de mesure
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C1524031
beats/min
Mean heart rate
Description

Mean heart rate

Type de données

integer

Unités de mesure
  • beats/min
Alias
UMLS CUI [1]
C1881634
beats/min
Number of ventricular runs
Description

Number of ventricular runs

Type de données

integer

Alias
UMLS CUI [1]
C2189285
Number of ventricular runs - not done, specify reason
Description

Number of ventricular runs - not done, specify reason

Type de données

text

Alias
UMLS CUI [1,1]
C2189285
UMLS CUI [1,2]
C2826287
Number of ventricular runs - not applicable
Description

Number of ventricular runs - not applicable

Type de données

text

Alias
UMLS CUI [1]
C2189285
Number of suprventricular runs
Description

Number of suprventricular runs

Type de données

integer

Alias
UMLS CUI [1,1]
C0039240
UMLS CUI [1,2]
C0018810
Number of suprventricular runs - not done, specify reason
Description

Number of suprventricular runs - not done, specify reason

Type de données

text

Alias
UMLS CUI [1,1]
C0039240
UMLS CUI [1,2]
C0018810
UMLS CUI [2]
C2826287
Number of suprventricular runs - not applicable
Description

Number of suprventricular runs - not applicable

Type de données

text

Alias
UMLS CUI [1,1]
C0039240
UMLS CUI [1,2]
C0018810
Interpretation of Holter
Description

Interpretation of Holter

Type de données

integer

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

Holter Abnormalities

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

Start Date and Time of Holter

Type de données

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C0013801
UMLS CUI [2,2]
C1301880
Stop Date and Time of Holter
Description

Stop Date and Time of Holter

Type de données

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C0013801
UMLS CUI [2,2]
C1522314
Holter Abnormalities
Description

Holter Abnormalities

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C1704258
Holter abnormality
Description

Holter abnormality

Type de données

text

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

Other abnormal rhythm, specify

Type de données

text

Alias
UMLS CUI [1,1]
C0199556
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0205394
UMLS CUI [2]
C2348235
Other morphology, specify
Description

Other morphology, specify

Type de données

text

Alias
UMLS CUI [1,1]
C0332437
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C2348235
Other conduction, specify
Description

Other conduction, specify

Type de données

text

Alias
UMLS CUI [1]
C0340494
UMLS CUI [2]
C2348235
Other myocardial infarction, specify
Description

Other myocardial infarction, specify

Type de données

text

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C2348235
Other depolarisation/repolrisation, specify
Description

Other depolarisation/repolrisation, specify

Type de données

text

Alias
UMLS CUI [1,1]
C0948857
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C2348235
Other abnormality/ Cardiologist comments
Description

Other abnormality/ Cardiologist comments

Type de données

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0175906
UMLS CUI [2,2]
C0947611
Holter monitoring method
Description

Holter monitoring method

Type de données

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0871511
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Similar models

Screening - Summary Holter; Holter Abnormalities

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Summary Holter
C0013801 (UMLS CUI-1)
C0242482 (UMLS CUI-2)
Sart Date and Time of Holter
Item
Sart Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Stop Date and Time of Holter
Item
Stop Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Maximum heart rate
Item
Maximum heart rate
integer
C0018810 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Minimum heart rate
Item
Minimum heart rate
integer
C0018810 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
Mean heart rate
Item
Mean heart rate
integer
C1881634 (UMLS CUI [1])
Number of ventricular runs
Item
Number of ventricular runs
integer
C2189285 (UMLS CUI [1])
Number of ventricular runs - not done, specify reason
Item
Number of ventricular runs - not done, specify reason
text
C2189285 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
Item
Number of ventricular runs - not applicable
text
C2189285 (UMLS CUI [1])
Number of ventricular runs - not applicable
Code List
Number of ventricular runs - not applicable
CL Item
Not applicable (X)
Number of suprventricular runs
Item
Number of suprventricular runs
integer
C0039240 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Number of suprventricular runs - not done, specify reason
Item
Number of suprventricular runs - not done, specify reason
text
C0039240 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C2826287 (UMLS CUI [2])
Item
Number of suprventricular runs - not applicable
text
C0039240 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Number of suprventricular runs - Not applicable
Code List
Number of suprventricular runs - not applicable
CL Item
Not applicable (X)
Item
Interpretation of Holter
integer
C0013801 (UMLS CUI [1,1])
C4086187 (UMLS CUI [1,2])
Interpretation of Holter
Code List
Interpretation of Holter
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (4)
CL Item
Unable to evaluate (5)
Item Group
Holter Abnormalities
C0013801 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
Start Date and Time of Holter
Item
Start Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Stop Date and Time of Holter
Item
Stop Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Item Group
Holter Abnormalities
C0013801 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
Item
Holter abnormality
text
C0013801 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
A. Rhythm
Code List
Holter abnormality
CL Item
Electrical alternans (A21)
CL Item
R on T phenomenon (A22)
CL Item
Ventricular fibrillation (A23)
CL Item
Trigeminy (A20)
CL Item
Ventricular premature depolarisation (A17)
CL Item
Sustained ventricular tachycardia (>100 beats/min, >30 beats) (A26)
CL Item
Non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (A25)
CL Item
Idioventricular rhythm (<= beats/min, defined by wide QRS complex) (A24)
CL Item
Sustained supraventricular tachycardia (>100 beats/min, >30 beats) (A12)
CL Item
Atrial flutter (A13)
CL Item
Monomorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (A28)
CL Item
Atrial fibrillation (A14)
CL Item
Monomorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (A29)
CL Item
Ventricular couplets (A18)
CL Item
Bigeminy (A19)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (A10)
CL Item
Non-sustained supraventricular tachycardia (>100 beats/min, 3-30 beats) (A11)
CL Item
Torsade de Pointes (TdP) (A32)
CL Item
Pacemaker (A33)
CL Item
Wide QRS tachycardia (diagnosis unknown) (A27)
CL Item
Polymorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (A30)
CL Item
Junctional rhythm (<=100 beats/min, defined by narrow QRS complex) (A15)
CL Item
Polymorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (A31)
CL Item
Junctional tachycardia (>100 beats/min) (A16)
CL Item
Short PR Interval (A35)
CL Item
No abnormalities (A00)
CL Item
Sinus bradycardia (50-59 beats/min) (A01)
CL Item
Sinus bradycardia (40-49 beats/min) (A02)
CL Item
Sinus bradycardia (30-39 beats/min) (A03)
CL Item
Sinus bradycardia (<30 beats/min) (A04)
CL Item
Sinus pause (A05)
CL Item
Sinus tachycardia (>100 beats/min) (A06)
CL Item
Ectopic supraventricular beats (A07)
CL Item
Ectopic supraventricular rhythm (A08)
CL Item
Wandering atrial pacemaker (A09)
CL Item
First degree AV block (PR Interval >200msec) (A34)
CL Item
Second degree AV block (Mobitz type 1) (A36)
CL Item
Second degree AV block (Mobitz type 2) (A37)
CL Item
2:1 AV block (A38)
CL Item
Third degree AV block (A39)
CL Item
Left axis deviation (QRS axis more negative thant -30 degrees) (A40)
CL Item
Right axis deviation (QRS axis more positive than +110 degrees) (A41)
CL Item
Incomplete right bundle branch block (A42)
CL Item
Incomplete left bundle branch block (A43)
CL Item
Right bundle branch block (A44)
CL Item
Left anterior hemiblock (A45)
CL Item
Left posterior hemiblock (A46)
CL Item
Left bundle branch block (A47)
CL Item
Bifascicular block (A48)
CL Item
Non-specific intraventricular conduction delay (QRS >=120 msec) (A49)
CL Item
Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-levine) (A50)
CL Item
QTc prolongation >=500 msec (A51)
CL Item
AV dissociation (A52)
CL Item
Myocardial Infarction, old (A53)
CL Item
Myocardial Infarction, non Q-wave (A54)
CL Item
Non-specific ST-T changes (A55)
CL Item
J point elevation (A56)
CL Item
ST elevation (A57)
CL Item
ST depression (A58)
CL Item
St segment abnormality (A59)
CL Item
U waves (A60)
CL Item
T wave Inversion (A61)
CL Item
T wave peaked (A62)
CL Item
T waves biphasic (A63)
CL Item
T waves flat (A64)
CL Item
Notched T-waves (A65)
CL Item
Low QRS voltage (A66)
CL Item
T wave abnormality (A67)
CL Item
Other abnormal rhythm (A94)
CL Item
Other morphology (A95)
CL Item
Other conduction (A96)
CL Item
Other myocardial infarction (A97)
CL Item
Other depolarisation/repolarisation (A98)
CL Item
Other abnormality/Cardiologist comments (A99)
Other abnormal rhythm, specify
Item
Other abnormal rhythm, specify
text
C0199556 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
Other morphology, specify
Item
Other morphology, specify
text
C0332437 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Other conduction, specify
Item
Other conduction, specify
text
C0340494 (UMLS CUI [1])
C2348235 (UMLS CUI [2])
Other myocardial infarction, specify
Item
Other myocardial infarction, specify
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Other depolarisation/repolrisation, specify
Item
Other depolarisation/repolrisation, specify
text
C0948857 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Other abnormality/ Cardiologist comments
Item
Other abnormality/ Cardiologist comments
text
C1704258 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
Item
Holter monitoring method
integer
C0013801 (UMLS CUI [1,1])
C0871511 (UMLS CUI [1,2])
Holter monitoring method
Code List
Holter monitoring method
CL Item
12 Lead 1000Hz (1)
CL Item
12 Lead 180Hz (2)
CL Item
3 Lead 180Hz (3)
CL Item
3 Lead 512Hz (4)
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