ID

29566

Descripción

Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains ECG Abnormalities Form Part 2.

Link

https://clinicaltrials.gov/ct2/show/NCT00318630

Palabras clave

Versiones (1)
  1. 6/4/18 6/4/18 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

6 de abril de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630

Inglés

ECG Abnormalities Form Part 2

1 formularios  
Conduction
Descripción

Conduction

Alias
UMLS CUI-1
C0264886
First degree AV block (PR interval > 200 msec)
Descripción

C 1 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085614
Short PR interval
Descripción

C 20 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0520878
Second degree AV block (Mobitz type 1)
Descripción

C 2 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0264907
Second degree AV block (Mobitz type 2)
Descripción

C 3 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0155700
2:1 AV block
Descripción

C 16 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2346542
Third degree AV block
Descripción

C 4 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151517
Left axis deviation (QRS axis more negative than -30°)
Descripción

C 5 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232297
Right axis deviation (QRS axis more positive than +110°)
Descripción

C 6 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232296
Incomplete right bundle branch block
Descripción

C 7 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0262525
Incomplete left bundle branch block
Descripción

C 13 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0281878
Right bundle branch block
Descripción

C 8 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085615
Left anterior hemiblock (synonymous to left anterior fascicular block)
Descripción

C 14 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0264912
Left posterior hemiblock (synonymous to left posterior fascicular block)
Descripción

C 15 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0264913
Left bundle branch block
Descripción

C 9 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023211
Bifascicular block
Descripción

C 17 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0264914
Non-specific intraventricular conduction delay (QRS ≥ 120 msec)
Descripción

C 10 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3697597
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Descripción

C 11 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0264897
UMLS CUI [2]
C0043202
UMLS CUI [3]
C0024054
Prolonged QT interval
Descripción

C 19 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151878
QT/QTc prolongation ≥ 500 msec
Descripción

C 12 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0151878
UMLS CUI [1,2]
C1560305
AV dissociation
Descripción

C 18 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004331
Other Conduction
Descripción

C 99 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0340494
Other Conduction: Comment
Descripción

C 99 Report, if clinically significant.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0340494
UMLS CUI [1,2]
C0947611
Myocardial infarction
Descripción

Myocardial infarction

Alias
UMLS CUI-1
C0027051
Myocardial infarction, old
Descripción

D 1 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0155668
Myocardial infarction, anterior
Descripción

D 2 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0340293
Myocardial infarction, lateral
Descripción

D 3 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0340312
Myocardial infarction, posterior
Descripción

D 4 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0340319
Myocardial infarction, inferior
Descripción

D 5 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0340305
Myocardial infarction, septal
Descripción

D 6 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0746727
Myocardial infarction, Non-Q wave
Descripción

D 20 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0542269
Other myocardial infarction
Descripción

D 98 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0205394
Other myocardial infarction: Comment
Descripción

Other myocardial infarction

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0947611
Depolarisation/Repolarisation, QRS-T
Descripción

Depolarisation/Repolarisation, QRS-T

Alias
UMLS CUI-1
C0948857
UMLS CUI-2
C1331539
UMLS CUI-3
C0520880
UMLS CUI-4
C0438167
Non-specific ST-T changes
Descripción

D 7 Record, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1112720
J point elevation
Descripción

D 19 Record, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2346597
ST elevation
Descripción

D 8 Record, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0520886
ST elevation-pericarditis
Descripción

D 21 Record, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348119
ST depression
Descripción

D 9 Record, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0520887
U waves abnormal
Descripción

D 10 Record, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0438169
T wave inversion
Descripción

D 11 Record, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0520888
T wave peaked
Descripción

D 12 Record, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0239242
T waves flat
Descripción

D 15 Record, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2215959
T waves biphasic
Descripción

D 16 Record, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348639
Notched T-waves
Descripción

D 18 Record, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2347367
Low QRS voltage
Descripción

D 13 Record, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2349945
T-wave flattening/inversion
Descripción

D 17 Record, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0520888
UMLS CUI [1,2]
C0429059
Other depolarisation/repolarisation
Descripción

D 99 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0948857
UMLS CUI [1,2]
C0205394
Other depolarisation/repolarisation: Comment
Descripción

Other depolarisation/repolarisation

Tipo de datos

text

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

Other abnormalities

Alias
UMLS CUI-1
C0522055
UMLS CUI-2
C0205394
Other abnormalities
Descripción

E 99 Report, if clinically significant.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0205394
Other abnormalities: Comment
Descripción

Other abnormalities

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0947611
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Similar models

ECG Abnormalities Form Part 2

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Conduction
C0264886 (UMLS CUI-1)
First degree AV block
Item
First degree AV block (PR interval > 200 msec)
boolean
C0085614 (UMLS CUI [1])
Short PR interval
Item
Short PR interval
boolean
C0520878 (UMLS CUI [1])
Second degree AV block (Mobitz type 1)
Item
Second degree AV block (Mobitz type 1)
boolean
C0264907 (UMLS CUI [1])
Second degree AV block (Mobitz type 2)
Item
Second degree AV block (Mobitz type 2)
boolean
C0155700 (UMLS CUI [1])
2:1 AV block
Item
2:1 AV block
boolean
C2346542 (UMLS CUI [1])
Third degree AV block
Item
Third degree AV block
boolean
C0151517 (UMLS CUI [1])
Left axis deviation (QRS axis more negative than -30°)
Item
Left axis deviation (QRS axis more negative than -30°)
boolean
C0232297 (UMLS CUI [1])
Right axis deviation (QRS axis more positive than +110°)
Item
Right axis deviation (QRS axis more positive than +110°)
boolean
C0232296 (UMLS CUI [1])
Incomplete right bundle branch block
Item
Incomplete right bundle branch block
boolean
C0262525 (UMLS CUI [1])
Incomplete left bundle branch block
Item
Incomplete left bundle branch block
boolean
C0281878 (UMLS CUI [1])
Right bundle branch block
Item
Right bundle branch block
boolean
C0085615 (UMLS CUI [1])
Left anterior hemiblock
Item
Left anterior hemiblock (synonymous to left anterior fascicular block)
boolean
C0264912 (UMLS CUI [1])
Left posterior hemiblock
Item
Left posterior hemiblock (synonymous to left posterior fascicular block)
boolean
C0264913 (UMLS CUI [1])
Left bundle branch block
Item
Left bundle branch block
boolean
C0023211 (UMLS CUI [1])
Bifascicular block
Item
Bifascicular block
boolean
C0264914 (UMLS CUI [1])
Non-specific intraventricular conduction delay (QRS ≥ 120 msec)
Item
Non-specific intraventricular conduction delay (QRS ≥ 120 msec)
boolean
C3697597 (UMLS CUI [1])
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
boolean
C0264897 (UMLS CUI [1])
C0043202 (UMLS CUI [2])
C0024054 (UMLS CUI [3])
Prolonged QT interval
Item
Prolonged QT interval
boolean
C0151878 (UMLS CUI [1])
QT/QTc prolongation ≥ 500 msec
Item
QT/QTc prolongation ≥ 500 msec
boolean
C0151878 (UMLS CUI [1,1])
C1560305 (UMLS CUI [1,2])
AV dissociation
Item
AV dissociation
boolean
C0004331 (UMLS CUI [1])
Other Conduction
Item
Other Conduction
boolean
C0340494 (UMLS CUI [1])
Other Conduction
Item
Other Conduction: Comment
text
C0340494 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Myocardial infarction
C0027051 (UMLS CUI-1)
Myocardial infarction, old
Item
Myocardial infarction, old
boolean
C0155668 (UMLS CUI [1])
Myocardial infarction, anterior
Item
Myocardial infarction, anterior
boolean
C0340293 (UMLS CUI [1])
Myocardial infarction, lateral
Item
Myocardial infarction, lateral
boolean
C0340312 (UMLS CUI [1])
Myocardial infarction, posterior
Item
Myocardial infarction, posterior
boolean
C0340319 (UMLS CUI [1])
Myocardial infarction, inferior
Item
Myocardial infarction, inferior
boolean
C0340305 (UMLS CUI [1])
Myocardial infarction, septal
Item
Myocardial infarction, septal
boolean
C0746727 (UMLS CUI [1])
Myocardial infarction, Non-Q wave
Item
Myocardial infarction, Non-Q wave
boolean
C0542269 (UMLS CUI [1])
Other myocardial infarction
Item
Other myocardial infarction
boolean
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other myocardial infarction
Item
Other myocardial infarction: Comment
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item Group
Depolarisation/Repolarisation, QRS-T
C0948857 (UMLS CUI-1)
C1331539 (UMLS CUI-2)
C0520880 (UMLS CUI-3)
C0438167 (UMLS CUI-4)
Non-specific ST-T changes
Item
Non-specific ST-T changes
boolean
C1112720 (UMLS CUI [1])
J point elevation
Item
J point elevation
boolean
C2346597 (UMLS CUI [1])
ST elevation
Item
ST elevation
boolean
C0520886 (UMLS CUI [1])
ST elevation-pericarditis
Item
ST elevation-pericarditis
boolean
C2348119 (UMLS CUI [1])
ST depression
Item
ST depression
boolean
C0520887 (UMLS CUI [1])
U waves abnormal
Item
U waves abnormal
boolean
C0438169 (UMLS CUI [1])
T wave inversion
Item
T wave inversion
boolean
C0520888 (UMLS CUI [1])
T wave peaked
Item
T wave peaked
boolean
C0239242 (UMLS CUI [1])
T waves flat
Item
T waves flat
boolean
C2215959 (UMLS CUI [1])
T waves biphasic
Item
T waves biphasic
boolean
C2348639 (UMLS CUI [1])
Notched T-waves
Item
Notched T-waves
boolean
C2347367 (UMLS CUI [1])
Low QRS voltage
Item
Low QRS voltage
boolean
C2349945 (UMLS CUI [1])
T-wave flattening/inversion
Item
T-wave flattening/inversion
boolean
C0520888 (UMLS CUI [1,1])
C0429059 (UMLS CUI [1,2])
Other depolarisation/repolarisation
Item
Other depolarisation/repolarisation
boolean
C0948857 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other depolarisation/repolarisation
Item
Other depolarisation/repolarisation: Comment
text
C0948857 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item Group
Other abnormalities
C0522055 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Other abnormalities
Item
Other abnormalities
boolean
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other abnormalities
Item
Other abnormalities: Comment
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
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