ID

29565

Description

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 1.

Link

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

Keywords

Versions (1)
  1. 4/6/18 4/6/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

April 6, 2018

DOI

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License

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

English

ECG Abnormalities Form Part 1

1 forms  
Date and Time of ECG
Description

Date and Time of ECG

Alias
UMLS CUI-1
C2826846
Date of ECG
Description

Date of ECG

Data type

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Description

Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
Rhythm
Description

Rhythm

Alias
UMLS CUI-1
C0232187
Sinus bradycardia
Description

A 1 Record, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0085610
Sinus bradycardia frequency
Description

Sinus bradycardia frequency

Data type

text

Alias
UMLS CUI [1,1]
C0085610
UMLS CUI [1,2]
C0439603
Sinus pause
Description

Record, if clinically significant. A 3

Data type

boolean

Alias
UMLS CUI [1]
C1955864
Sinus tachycardia (heart rate >100 beats/min)
Description

A 2 Record, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0039239
Ectopic supraventricular beats
Description

A 4 Record, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0033036
Ectopic supraventricular rhythm
Description

A 20 Record, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C2348376
Wandering Atrial Pacemaker
Description

A 17 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C1321523
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min)
Description

A 26 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0221158
Supraventricular tachycardia (heart rate >100 beats/min)
Description

A 6 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0039240
Atrial flutter
Description

A 7 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0004239
Atrial fibrillation
Description

A 8 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0004238
Junctional rhythm (heart rate ≤100 beats/min)
Description

A 5 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1,1]
C0232208
UMLS CUI [1,2]
C0018810
Junctional rhythm
Description

A 25 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0232208
Junctional tachycardia (heart rate > 100 beats/min)
Description

A 24 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0039235
Ectopic ventricular beats
Description

A 9 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0151636
Ventricular couplets
Description

A 12 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0429001
Bigeminy
Description

A 13 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0262662
Trigeminy
Description

A 28 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0428999
Electrical alternans
Description

A 14 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C1142551
R on T phenomenon
Description

A 29 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0877658
Ventricular fibrillation
Description

A 18 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0042510
Idioventricular rhythm (heart rate < 100 beats/min)
Description

A 19 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1,1]
C0700363
UMLS CUI [1,2]
C0018810
Sustained ventricular tachycardia
Description

A 10 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0750197
Non-sustained ventricular tachycardia
Description

A 11 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0750194
Wide QRS Tachycardia (diagnosis unknown)
Description

A 32 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0344429
Ventricular Tachycardia
Description

A 27 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0042514
Monomorphic ventricular tachycardia
Description

A 30 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0344431
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
Description

A 15 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0040479
Polymorphic (sustained and non-sustained) ventricular tachycardia
Description

A 31 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0344432
Artificial pacemaker
Description

A 16 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0030163
Other abnormal rhythm
Description

A 99 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1,1]
C1533266
UMLS CUI [1,2]
C0205394
Other abnormal rhythm: comment
Description

Other abnormal rhythm

Data type

text

Alias
UMLS CUI [1,1]
C1533266
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0947611
P-wave and QRS morphology
Description

P-wave and QRS morphology

Alias
UMLS CUI-1
C2216025
UMLS CUI-2
C0429098
Left atrial abnormality (P mitrale)
Description

B 1 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1,1]
C0344711
UMLS CUI [1,2]
C0232310
Right atrial abnormality (P pulmonale)
Description

B 2 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1,1]
C0344696
UMLS CUI [1,2]
C0232308
Right ventricular hypertrophy
Description

B 3 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C0162770
Intraatrial conduction delay
Description

A 5 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C2346510
Increased voltage consistent with left ventricular hypertrophy
Description

D 14 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1]
C1112650
UMLS CUI [2]
C0149721
Other morphology
Description

B 99 Report, if clinically significant.

Data type

boolean

Alias
UMLS CUI [1,1]
C2216025
UMLS CUI [1,2]
C0429098
UMLS CUI [1,3]
C0205394
Other morphology: Comment
Description

Other morphology

Data type

text

Alias
UMLS CUI [1,1]
C2216025
UMLS CUI [1,2]
C0429098
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0947611
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Similar models

ECG Abnormalities Form Part 1

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date and Time of ECG
C2826846 (UMLS CUI-1)
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
Rhythm
C0232187 (UMLS CUI-1)
Sinus bradycardia
Item
Sinus bradycardia
boolean
C0085610 (UMLS CUI [1])
Item
Sinus bradycardia frequency
text
C0085610 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Sinus bradycardia frequency
Code List
Sinus bradycardia frequency
CL Item
heart rate 40-50 beats/min (A21)
CL Item
heart rate 30-39 beats/min (A22)
CL Item
heart rate <30 beats/min (A23)
Sinus pause
Item
Sinus pause
boolean
C1955864 (UMLS CUI [1])
Sinus tachycardia
Item
Sinus tachycardia (heart rate >100 beats/min)
boolean
C0039239 (UMLS CUI [1])
Ectopic supraventricular beats
Item
Ectopic supraventricular beats
boolean
C0033036 (UMLS CUI [1])
Ectopic supraventricular rhythm
Item
Ectopic supraventricular rhythm
boolean
C2348376 (UMLS CUI [1])
Wandering Atrial Pacemaker
Item
Wandering Atrial Pacemaker
boolean
C1321523 (UMLS CUI [1])
Multifocal atrial tachycardia
Item
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min)
boolean
C0221158 (UMLS CUI [1])
Supraventricular tachycardia
Item
Supraventricular tachycardia (heart rate >100 beats/min)
boolean
C0039240 (UMLS CUI [1])
Atrial flutter
Item
Atrial flutter
boolean
C0004239 (UMLS CUI [1])
Atrial fibrillation
Item
Atrial fibrillation
boolean
C0004238 (UMLS CUI [1])
Junctional rhythm (heart rate ≤100 beats/min)
Item
Junctional rhythm (heart rate ≤100 beats/min)
boolean
C0232208 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Junctional rhythm
Item
Junctional rhythm
boolean
C0232208 (UMLS CUI [1])
Junctional tachycardia (heart rate > 100 beats/min)
Item
Junctional tachycardia (heart rate > 100 beats/min)
boolean
C0039235 (UMLS CUI [1])
Ectopic ventricular beats
Item
Ectopic ventricular beats
boolean
C0151636 (UMLS CUI [1])
Ventricular couplets
Item
Ventricular couplets
boolean
C0429001 (UMLS CUI [1])
Bigeminy
Item
Bigeminy
boolean
C0262662 (UMLS CUI [1])
Trigeminy
Item
Trigeminy
boolean
C0428999 (UMLS CUI [1])
Electrical alternans
Item
Electrical alternans
boolean
C1142551 (UMLS CUI [1])
R on T phenomenon
Item
R on T phenomenon
boolean
C0877658 (UMLS CUI [1])
Ventricular fibrillation
Item
Ventricular fibrillation
boolean
C0042510 (UMLS CUI [1])
Idioventricular rhythm (heart rate < 100 beats/min)
Item
Idioventricular rhythm (heart rate < 100 beats/min)
boolean
C0700363 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Sustained ventricular tachycardia
Item
Sustained ventricular tachycardia
boolean
C0750197 (UMLS CUI [1])
Non-sustained ventricular tachycardia
Item
Non-sustained ventricular tachycardia
boolean
C0750194 (UMLS CUI [1])
Wide QRS Tachycardia (diagnosis unknown)
Item
Wide QRS Tachycardia (diagnosis unknown)
boolean
C0344429 (UMLS CUI [1])
Ventricular Tachycardia
Item
Ventricular Tachycardia
boolean
C0042514 (UMLS CUI [1])
Monomorphic ventricular tachycardia
Item
Monomorphic ventricular tachycardia
boolean
C0344431 (UMLS CUI [1])
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
boolean
C0040479 (UMLS CUI [1])
Polymorphic (sustained and non-sustained) ventricular tachycardia
Item
Polymorphic (sustained and non-sustained) ventricular tachycardia
boolean
C0344432 (UMLS CUI [1])
Artificial pacemaker
Item
Artificial pacemaker
boolean
C0030163 (UMLS CUI [1])
Other abnormal rhythm
Item
Other abnormal rhythm
boolean
C1533266 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other abnormal rhythm
Item
Other abnormal rhythm: comment
text
C1533266 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item Group
P-wave and QRS morphology
C2216025 (UMLS CUI-1)
C0429098 (UMLS CUI-2)
Left atrial abnormality (P mitrale)
Item
Left atrial abnormality (P mitrale)
boolean
C0344711 (UMLS CUI [1,1])
C0232310 (UMLS CUI [1,2])
Right atrial abnormality (P pulmonale)
Item
Right atrial abnormality (P pulmonale)
boolean
C0344696 (UMLS CUI [1,1])
C0232308 (UMLS CUI [1,2])
Right ventricular hypertrophy
Item
Right ventricular hypertrophy
boolean
C0162770 (UMLS CUI [1])
Intraatrial conduction delay
Item
Intraatrial conduction delay
boolean
C2346510 (UMLS CUI [1])
Increased voltage, left ventricular hypertrophy
Item
Increased voltage consistent with left ventricular hypertrophy
boolean
C1112650 (UMLS CUI [1])
C0149721 (UMLS CUI [2])
Other morphology
Item
Other morphology
boolean
C2216025 (UMLS CUI [1,1])
C0429098 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Other morphology
Item
Other morphology: Comment
text
C2216025 (UMLS CUI [1,1])
C0429098 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
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