ID

41741

Beschreibung

Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

Stichworte

Versionen (1)
  1. 09.01.21 09.01.21 -
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GlaxoSmithKline

Hochgeladen am

9. Januar 2021

DOI

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Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096)

Englisch

Screening - 12 Lead ECG; 12-Lead ECG Abnormalities; Pulmonary Function Tests; Inhaler Device Training

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
12-Lead ECG
Beschreibung

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Start date of ECG
Beschreibung

Start date of ECG

Datentyp

date

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

Planned Relative Time (ECG)

Datentyp

integer

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

Start Time of ECG

Datentyp

time

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

Ventricular Rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C2189285
beats/min
PR Interval
Beschreibung

PR Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Beschreibung

QRS Duration

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Beschreibung

Uncorrected QT Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval
Beschreibung

QTc Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Result of the ECG
Beschreibung

Result of the ECG

Datentyp

integer

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

12-Lead ECG Abnormalities

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

Date of ECG

Datentyp

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Beschreibung

Time of ECG

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
12-Lead ECG Abnormalities
Beschreibung

12-Lead ECG Abnormalities

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1704258
A. Rhythm
Beschreibung

A. Rhythm

Datentyp

text

Alias
UMLS CUI [1]
C0232187
Other abnormal rhythm - Comment
Beschreibung

Other abnormal rhythm - Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0232187
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0947611
B. P-Wave and QRS Morphology
Beschreibung

B. P-Wave and QRS Morphology

Datentyp

text

Alias
UMLS CUI [1]
C2216025
UMLS CUI [2]
C0429098
Other P-Wave and QRS Morphology - Comment
Beschreibung

Other P-Wave and QRS Morphology - Comment

Datentyp

text

Alias
UMLS CUI [1]
C2216025
UMLS CUI [2]
C0429098
UMLS CUI [3]
C0205394
UMLS CUI [4]
C0947611
C. Conduction
Beschreibung

C. Conduction

Datentyp

text

Alias
UMLS CUI [1]
C0232217
Other Conduction - Comment
Beschreibung

Other Conduction - Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0232217
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0947611
D. Myocaridal Infarction
Beschreibung

D. Myocaridal Infarction

Datentyp

text

Alias
UMLS CUI [1]
C0027051
Other Myocardial Infarction - Comment
Beschreibung

Other Myocardial Infarction - Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0947611
E. Depolarisation/ Repolarisation (QRS-T)
Beschreibung

E. Depolarisation/ Repolarisation (QRS-T)

Datentyp

text

Alias
UMLS CUI [1,1]
C1395184
UMLS CUI [1,2]
C0948857
Other Depolarisation/ Repolarisation (QRS-T) - Comment
Beschreibung

Other Depolarisation/ Repolarisation (QRS-T) - Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C1395184
UMLS CUI [1,2]
C0948857
UMLS CUI [1,3]
C0205394
UMLS CUI [2]
C0947611
Other abnormalities
Beschreibung

Other abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0205394
Other abnormalities - Comment
Beschreibung

Other abnormalities - Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0947611
Pulmonary Function Tests
Beschreibung

Pulmonary Function Tests

Alias
UMLS CUI-1
C0024119
Date (Pulmonary Function Tests)
Beschreibung

Date (Pulmonary Function Tests)

Datentyp

date

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0011008
Pulmonary Function Test
Beschreibung

Pulmonary Function Test

Datentyp

integer

Alias
UMLS CUI [1]
C0024119
Planned Relative Time (Pulmonary Function Tests)
Beschreibung

Planned Relative Time (Pulmonary Function Tests)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0439564
Actual Time of First Reading (Pulmonary Function Tests)
Beschreibung

Actual Time of First Reading (Pulmonary Function Tests)

Datentyp

time

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0040223
Reading 1 (Pulmonary Function Tests)
Beschreibung

Reading 1 (Pulmonary Function Tests)

Datentyp

float

Maßeinheiten
  • L
Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0243095
L
Reading 2 (Pulmonary Function Tests)
Beschreibung

Reading 2 (Pulmonary Function Tests)

Datentyp

float

Maßeinheiten
  • L
Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0243095
L
Reading 3 (Pulmonary Function Tests)
Beschreibung

Reading 3 (Pulmonary Function Tests)

Datentyp

float

Maßeinheiten
  • L
Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0243095
L
Highest Reading (Pulmonary Function Tests) - A
Beschreibung

Highest Reading (Pulmonary Function Tests) - A

Datentyp

float

Maßeinheiten
  • L
Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C1522410
L
Predicted Normal (Pulmonary Function Tests) - B
Beschreibung

Predicted Normal (Pulmonary Function Tests) - B

Datentyp

float

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0205307
% Predicted Normal (Pulmonary Function Tests) - A/Bx100
Beschreibung

% Predicted Normal (Pulmonary Function Tests) - A/Bx100

Datentyp

float

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0205307
UMLS CUI [2]
C0439165
Inhaler Device Training
Beschreibung

Inhaler Device Training

Alias
UMLS CUI-1
C0021461
UMLS CUI-2
C0220931
Has the subject received training on how to use the Diskus?
Beschreibung

Has the subject received training on how to use the Diskus?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021461
UMLS CUI [1,2]
C0220931
Is the subject able to use the Diskus correctly?
Beschreibung

Is the subject able to use the Diskus correctly?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2349182
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0021461
UMLS CUI [1,4]
C1553480
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Ähnliche Modelle

Screening - 12 Lead ECG; 12-Lead ECG Abnormalities; Pulmonary Function Tests; Inhaler Device Training

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Start date of ECG
Item
Start date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Planned Relative Time (ECG)
integer
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Planned Relative Time (ECG)
Code List
Planned Relative Time (ECG)
CL Item
Screening (1)
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Ventricular Rate
Item
Ventricular Rate
integer
C2189285 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
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)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Item Group
12-Lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
Item
A. Rhythm
text
C0232187 (UMLS CUI [1])
A. Rhythm
Code List
A. Rhythm
CL Item
Sinus bradycardia (A1)
CL Item
Sinus bradycardia (heart rate 40 - 50 beats/min) (A21)
CL Item
Sinus bradycardia (heart rate 30 - 39 beats/min) (A22)
CL Item
Sinus bradycardia (heart rate <30 beats/min) (A23)
CL Item
Sinus pause (A3)
CL Item
Sinus tachycardia (heart rate >100 beats/min) (A2)
CL Item
Ectopic supraventricular beats (A4)
CL Item
Ectopic supraventricular rhythm (A20)
CL Item
Wandering atrial pacemaker (A17)
CL Item
Multifocal tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min) (A26)
CL Item
Supraventricular tachycardia (heart rate >100 beats/min) (A6)
CL Item
Atrial flutter (A7)
CL Item
Atrial fibrillation (A8)
CL Item
Junctional rhythm (heart rate <=100 beats/min) (A5)
CL Item
Junctional rhythm (A26)
CL Item
Junctional tachycardia (heart rate >100 beats/min) (A24)
CL Item
Ectopic ventricular beats (A9)
CL Item
Ventricular couplets (A12)
CL Item
Bigeminy (A13)
CL Item
Trigeminy (A28)
CL Item
Electrical alternans (A14)
CL Item
R on T phenomenon (A29)
CL Item
Ventricular fibrillation (A18)
CL Item
Idioventricular rhythm (heart rate <100 beats/min) (A19)
CL Item
Sustained ventricular tachycardia (A10)
CL Item
Non-sustained ventricular tachycardia (A11)
CL Item
Ventricular tachycardia (A27)
CL Item
Monomorphic ventricular tachycardia (A30)
CL Item
Torsade de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (A15)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (A31)
CL Item
Artificial pacemaker (A16)
CL Item
Other abnormal rhythm (A99)
Other abnormal rhythm - Comment
Item
Other abnormal rhythm - Comment
text
C0232187 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Item
B. P-Wave and QRS Morphology
text
C2216025 (UMLS CUI [1])
C0429098 (UMLS CUI [2])
B. P-Wave and QRS Morphology
Code List
B. P-Wave and QRS Morphology
CL Item
Left atrial abnormality (P mitrale) (B1)
CL Item
Right atrial abnormality (P pulmonale) (B2)
CL Item
Right ventricular hypertrophy (B3)
CL Item
Intraatrial conduction delay (B5)
CL Item
Increased voltage consistent with left ventricular hypertrophy (D14)
CL Item
Other morphology (B99)
Other P-Wave and QRS Morphology - Comment
Item
Other P-Wave and QRS Morphology - Comment
text
C2216025 (UMLS CUI [1])
C0429098 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C0947611 (UMLS CUI [4])
Item
C. Conduction
text
C0232217 (UMLS CUI [1])
C. Conduction
Code List
C. Conduction
CL Item
First degree AV block (PR interval >200msec) (C1)
CL Item
Second degree AV block (Mobitz type 1) (C2)
CL Item
Second degree AV block (Mobitz type 2) (C3)
CL Item
2:1 AV block (C16)
CL Item
Third degree AV block (C4)
CL Item
Left axis deviation (QRS axis more negative than -30°) (C5)
CL Item
Right axis deviation (QRS axis more positive than +110°) (C6)
CL Item
Incomplete right bundle branch block (C7)
CL Item
Incomplete left bundle branch block (C13)
CL Item
Right bundle branch block (C8)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (C14)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (C15)
CL Item
Left bundle branch block (C9)
CL Item
Bifascicular block (C17)
CL Item
Non-specific intraventricular conduction delay (QRS >= 120msec) (C10)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (C11)
CL Item
QT/QTc prolongation >= 500 ms (C12)
CL Item
AV dissociation (C18)
CL Item
Other conduction (C99)
Other Conduction - Comment
Item
Other Conduction - Comment
text
C0232217 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Item
D. Myocaridal Infarction
text
C0027051 (UMLS CUI [1])
D. Myocaridal Infarction
Code List
D. Myocaridal Infarction
CL Item
Myocaridal infarction, old (D1)
CL Item
Myocardial infarction, anterior (D2)
CL Item
Myocardial infarction, lateral (D3)
CL Item
Myocardial infarction, posterior (D4)
CL Item
Myocardial infarction, inferior (D5)
CL Item
Myocardial infarction, septal (D6)
CL Item
Myocardial infarction, Non-Q wave (D20)
CL Item
Other myocardial infarction (D98)
Other Myocardial Infarction - Comment
Item
Other Myocardial Infarction - Comment
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Item
E. Depolarisation/ Repolarisation (QRS-T)
text
C1395184 (UMLS CUI [1,1])
C0948857 (UMLS CUI [1,2])
E. Depolarisation/ Repolarisation (QRS-T)
Code List
E. Depolarisation/ Repolarisation (QRS-T)
CL Item
Non-specific ST-T changes (D7)
CL Item
J point elevation (D19)
CL Item
ST elevation (D8)
CL Item
ST elevation-pericarditis (D21)
CL Item
ST depression (D9)
CL Item
U waves abnormal (D10)
CL Item
T-wave inversion (D11)
CL Item
T wave peaked (D12)
CL Item
T waves flat (D15)
CL Item
T waves biphasic (D16)
CL Item
Notched T-waves (D18)
CL Item
Low QRS voltage (D13)
CL Item
T-wave flattening/inversion (D17)
CL Item
Other depolarisatoin/repolarisation (D99)
Other Depolarisation/ Repolarisation (QRS-T) - Comment
Item
Other Depolarisation/ Repolarisation (QRS-T) - Comment
text
C1395184 (UMLS CUI [1,1])
C0948857 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
Item
Other abnormalities
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other abnormalities
Code List
Other abnormalities
CL Item
Other abnormalities (E99)
Other abnormalities - Comment
Item
Other abnormalities - Comment
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Item Group
Pulmonary Function Tests
C0024119 (UMLS CUI-1)
Date (Pulmonary Function Tests)
Item
Date (Pulmonary Function Tests)
date
C0024119 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Pulmonary Function Test
integer
C0024119 (UMLS CUI [1])
Pulmonary Function Test
Code List
Pulmonary Function Test
CL Item
FEV1 (1)
CL Item
FVC (2)
CL Item
PEFR (3)
Item
Planned Relative Time (Pulmonary Function Tests)
integer
C0024119 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Planned Relative Time (Pulmonary Function Tests)
Code List
Planned Relative Time (Pulmonary Function Tests)
CL Item
Screening (1)
CL Item
Unscheduled (2)
Actual Time of First Reading (Pulmonary Function Tests)
Item
Actual Time of First Reading (Pulmonary Function Tests)
time
C0024119 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Reading 1 (Pulmonary Function Tests)
Item
Reading 1 (Pulmonary Function Tests)
float
C0024119 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Reading 2 (Pulmonary Function Tests)
Item
Reading 2 (Pulmonary Function Tests)
float
C0024119 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Reading 3 (Pulmonary Function Tests)
Item
Reading 3 (Pulmonary Function Tests)
float
C0024119 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Highest Reading (Pulmonary Function Tests) - A
Item
Highest Reading (Pulmonary Function Tests) - A
float
C0024119 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C1522410 (UMLS CUI [1,3])
Predicted Normal (Pulmonary Function Tests) - B
Item
Predicted Normal (Pulmonary Function Tests) - B
float
C0024119 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
% Predicted Normal (Pulmonary Function Tests) - A/Bx100
Item
% Predicted Normal (Pulmonary Function Tests) - A/Bx100
float
C0024119 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0439165 (UMLS CUI [2])
Item Group
Inhaler Device Training
C0021461 (UMLS CUI-1)
C0220931 (UMLS CUI-2)
Has the subject received training on how to use the Diskus?
Item
Has the subject received training on how to use the Diskus?
boolean
C0021461 (UMLS CUI [1,1])
C0220931 (UMLS CUI [1,2])
Is the subject able to use the Diskus correctly?
Item
Is the subject able to use the Diskus correctly?
boolean
C2349182 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0021461 (UMLS CUI [1,3])
C1553480 (UMLS CUI [1,4])
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