ID

38070

Description

Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Keywords

Versions (1)
  1. 9/15/19 9/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 15, 2019

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Creative Commons BY-NC 3.0
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Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036

English

12-Lead ECG Abnormalities

1 forms  
12-Lead ECG Abnormalities
Description

12-Lead ECG Abnormalities

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1704258
Date and Time of ECG
Description

12 lead ECG, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Record clinically significant abnormalities - Rhythm
Description

12 lead ECG, Abnormality, Rhythm

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0199556
Record clinically significant abnormalities - Rhythm - Comment
Description

12 lead ECG, Abnormality, Rhythm

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0199556
Record clinically significant abnormalities - P-Wave Morphology
Description

12 lead ECG, Abnormality, P wave shifting morphology

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2216025
Record clinically significant abnormalities - P-Wave Morphology - Comment
Description

12 lead ECG, Abnormality, P wave shifting morphology

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2216025
Record clinically significant abnormalities - Conduction
Description

12 lead ECG, Abnormality, Cardiac conduction

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0232217
Record clinically significant abnormalities - Conduction - Comment
Description

12 lead ECG, Abnormality, Cardiac conduction

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0232217
Record clinically significant abnormalities - Myocardial Infarction
Description

12 lead ECG, Abnormality, Myocardial Infarction

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0027051
Record clinically significant abnormalities - Myocardial Infarction - Comment
Description

12 lead ECG, Abnormality, Myocardial Infarction

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0027051
Record clinically significant abnormalities - Depolarisation/Repolarisation (QRS-T)
Description

12 lead ECG, Abnormality,Ventricular Depolarization, Electrocardiogram repolarisation abnormality

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C1331539
UMLS CUI [1,4]
C0948857
Record clinically significant abnormalities - Depolarisation/Repolarisation (QRS-T) - Comment
Description

12 lead ECG, Abnormality,Ventricular Depolarization, Electrocardiogram repolarisation abnormality

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C1331539
UMLS CUI [1,4]
C0948857
Record clinically significant abnormalities - Other abnormalities, enter comment
Description

12 lead ECG, Abnormality,Other

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0205394
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Similar models

12-Lead ECG Abnormalities

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
12-Lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
12 lead ECG, Date in time, Time
Item
Date and Time of ECG
datetime
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Record clinically significant abnormalities - Rhythm
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
12 lead ECG, Abnormality, Rhythm
Code List
Record clinically significant abnormalities - Rhythm
CL Item
Sinus bradycardia (1)
CL Item
Sinus bradycardia (heart rate 40-50 beats/min) (2)
CL Item
Sinus bradycardia (heart rate 30-39 beats/min) (3)
CL Item
Sinus bradycardia (heart rate <30 beats/min) (4)
CL Item
Sinus pause (5)
CL Item
Sinus tachycardia (heart rate >100 beats/min) (6)
CL Item
Ectopic supraventricular beats (7)
CL Item
Wandering atrial pacemaker (8)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (9)
CL Item
Supraventricular tachycardia (heart rate >100 beats/min) (10)
CL Item
Atrial flutter (11)
CL Item
Atrial fibrillation (12)
CL Item
Junctional rhythm (heart rate <=100 beats/min) (13)
CL Item
Junctional rhythm (14)
CL Item
Ectopic ventricular beats (15)
CL Item
Ventricular couplets  (16)
CL Item
Bigeminy (17)
CL Item
Trigeminy (18)
CL Item
Electrical alternans (19)
CL Item
R on T phenomenon (20)
CL Item
Ventricular fibrillation (21)
CL Item
Idioventricular rhythm (22)
CL Item
Sustained ventricular tachycardia (23)
CL Item
Non-sustained ventricular tachycardia (24)
CL Item
Ventricular tachycardia (25)
CL Item
Monomorphic ventricular tachycardia (26)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (27)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia  (28)
CL Item
Artificial pacemaker (29)
CL Item
Other abnormal rhythm, enter comment (30)
12 lead ECG, Abnormality, Rhythm
Item
Record clinically significant abnormalities - Rhythm - Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
Item
Record clinically significant abnormalities - P-Wave Morphology
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
12 lead ECG, Abnormality, P wave shifting morphology
Code List
Record clinically significant abnormalities - P-Wave Morphology
CL Item
Left atrial abnormality (P mitrale) (1)
CL Item
Right atrial abnormality (P pulmonale) (2)
CL Item
Right ventricular hypertrophy (3)
CL Item
Intraatrial conduction delay  (4)
CL Item
Increased voltage consistent with left ventricular hypertrophy (5)
CL Item
Other morphology, enter comment (6)
Item
Record clinically significant abnormalities - P-Wave Morphology - Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
12 lead ECG, Abnormality, P wave shifting morphology
Code List
Record clinically significant abnormalities - P-Wave Morphology - Comment
Item
Record clinically significant abnormalities - Conduction
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
12 lead ECG, Abnormality, Cardiac conduction
Code List
Record clinically significant abnormalities - Conduction
CL Item
First degree AV block (PR interval > 200msec) (1)
CL Item
Second degree AV block (Mobitz type 1) (2)
CL Item
Second degree AV block (Mobitz type 2) (3)
CL Item
2:1 AV block (4)
CL Item
Third degree AV block (5)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees) (6)
CL Item
Right axis deviation (QRS axis more positive than +110 degrees) (7)
CL Item
Incomplete right bundle branch block (8)
CL Item
Right bundle branch block (9)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (10)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (11)
CL Item
Left bundle branch block (12)
CL Item
Bifascicular block  (13)
CL Item
Non-specific intraventricular conduction delay (QRS >= 120 msec) (14)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (15)
CL Item
QT/QTc prolongation >= 500 msec (16)
CL Item
AV dissociation (17)
CL Item
Other conduction, enter comment (18)
12 lead ECG, Abnormality, Cardiac conduction
Item
Record clinically significant abnormalities - Conduction - Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
Item
Record clinically significant abnormalities - Myocardial Infarction
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
12 lead ECG, Abnormality, Myocardial Infarction
Code List
Record clinically significant abnormalities - Myocardial Infarction
CL Item
Myocardial infarction, old (1)
CL Item
Myocardial infarction, anterior (2)
CL Item
Myocardial infarction, lateral (3)
CL Item
Myocardial infarction, posterior (4)
CL Item
Myocardial infarction, inferior (5)
CL Item
Myocardial infarction, septal (6)
CL Item
Myocardial infarction, Non Q-wave (7)
CL Item
Other myocardial infarction, enter comment (8)
12 lead ECG, Abnormality, Myocardial Infarction
Item
Record clinically significant abnormalities - Myocardial Infarction - Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
Item
Record clinically significant abnormalities - Depolarisation/Repolarisation (QRS-T)
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0948857 (UMLS CUI [1,4])
12 lead ECG, Abnormality,Ventricular Depolarization, Electrocardiogram repolarisation abnormality
Code List
Record clinically significant abnormalities - Depolarisation/Repolarisation (QRS-T)
CL Item
Non-specific ST-T changes  (1)
CL Item
J point elevation (2)
CL Item
ST elevation (3)
CL Item
ST-elevation - pericarditis (4)
CL Item
ST depression (5)
CL Item
U waves abnormal (6)
CL Item
T wave inversion (7)
CL Item
T wave peaked (8)
CL Item
T waves flat (9)
CL Item
T waves biphasic (10)
CL Item
Notched T-waves (11)
CL Item
Low QRS voltage (12)
CL Item
T-wave flattening/inversion (13)
CL Item
Other depolarisation/repolarisation, enter comment (14)
12 lead ECG, Abnormality,Ventricular Depolarization, Electrocardiogram repolarisation abnormality
Item
Record clinically significant abnormalities - Depolarisation/Repolarisation (QRS-T) - Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0948857 (UMLS CUI [1,4])
12 lead ECG, Abnormality,Other
Item
Record clinically significant abnormalities - Other abnormalities, enter comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
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