ID

38954

Description

Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders

Keywords

Versions (1)
  1. 11/15/19 11/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 15, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597

English

Screening - 12-Lead ECG Abnormalities

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
12-Lead ECG Abnormalities
Description

12-Lead ECG Abnormalities

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1704258
ECG Number
Description

Transcribe from the 12 Lead ECG result page.

Data type

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0237753
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]
C0430456
UMLS CUI [1,2]
C1301880
12-Lead ECG Abnormalities
Description

12-Lead ECG Abnormalities

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

A. Rhythm

Data type

text

Alias
UMLS CUI [1]
C0199556
A. Rhythm - Comment
Description

A. Rhythm - Comment

Data type

text

Alias
UMLS CUI [1,1]
C0199556
UMLS CUI [1,2]
C0947611
B. P-Wave and QRS Morphology
Description

B. P-Wave and QRS Morphology

Data type

text

Alias
UMLS CUI [1,1]
C2216025
UMLS CUI [1,2]
C0429098
B. P-Wave and QRS Morphology - Comment
Description

B. P-Wave and QRS Morphology - Comment

Data type

text

Alias
UMLS CUI [1,1]
C2216025
UMLS CUI [1,2]
C0429098
UMLS CUI [1,3]
C0947611
C. Conduction
Description

C. Conduction

Data type

text

Alias
UMLS CUI [1]
C0264886
C. Conduction - Comment
Description

C. Conduction - Comment

Data type

text

Alias
UMLS CUI [1]
C0264886
D. Myocardial Infarction
Description

D. Myocardial Infarction

Data type

text

Alias
UMLS CUI [1]
C0027051
D. Myocardial Infarction - Comment
Description

D. Myocardial Infarction - Comment

Data type

text

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

E. Depolarisation/Repolarisation (QRS-T)

Data type

text

Alias
UMLS CUI [1,1]
C1331539
UMLS CUI [1,2]
C0948857
E. Depolarisation/Repolarisation (QRS-T) - Comment
Description

E. Depolarisation/Repolarisation (QRS-T) - Comment

Data type

text

Alias
UMLS CUI [1,1]
C1331539
UMLS CUI [1,2]
C0948857
UMLS CUI [1,3]
C0947611
Other Abnormalities
Description

Other Abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0205394
Other Abnormalities - Comment
Description

Other Abnormalities - Comment

Data type

text

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

Screening - 12-Lead ECG Abnormalities

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
12-Lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
ECG Number
Item
ECG Number
integer
C0430456 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item Group
12-Lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
Item
A. Rhythm
text
C0199556 (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 atrial 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 (A25)
CL Item
Junctional tachycardia (heart rate > 100 beats/min) (A24)
CL Item
Ectopic ventricular beats (A 9)
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
Wide QRS Tachycardia (diagnosis unknown) (A32)
CL Item
Sinus arrhythmia (A33)
CL Item
Ventricular tachycardia (A27)
CL Item
Monomorphic ventricular tachycardia (A30)
CL Item
Torsades 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
Atrial premature complex (A35)
CL Item
Other abnormal rhythm (A99)
A. Rhythm - Comment
Item
A. Rhythm - Comment
text
C0199556 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
B. P-Wave and QRS Morphology
text
C2216025 (UMLS CUI [1,1])
C0429098 (UMLS CUI [1,2])
B. P-Wave and QRS Morphology
Code List
B. P-Wave and QRS Morphology
CL Item
Right ventricular hypertrophy (B3)
CL Item
Intraatrial conduction delay (B5)
CL Item
Poor R wave progression (B7)
CL Item
Left atrial abnormality (B9)
CL Item
Right atrial abnormality (B10)
CL Item
Late R wave transition (B16)
CL Item
Increased voltage consistent with left ventricular hypertrophy (D14)
CL Item
Other morphology (B99)
B. P-Wave and QRS Morphology - Comment
Item
B. P-Wave and QRS Morphology - Comment
text
C2216025 (UMLS CUI [1,1])
C0429098 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
C. Conduction
text
C0264886 (UMLS CUI [1])
C. Conduction
Code List
C. Conduction
CL Item
First degree AV block (PR interval > 200 msec) (C1)
CL Item
Short PR interval (C20)
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 morepositive 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 120 msec) (C10)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (C11)
CL Item
AV dissociation (C18)
CL Item
Prolonged QT 450-500 (C28)
CL Item
Prolonged QT >500 (C29)
CL Item
Prolonged QTc Interval 450-500 (C30)
CL Item
Prolonged QTc Interval >500 (C31)
CL Item
Other conduction (C99)
C. Conduction - Comment
Item
C. Conduction - Comment
text
C0264886 (UMLS CUI [1])
Item
D. Myocardial Infarction
text
C0027051 (UMLS CUI [1])
D. Myocardial Infarction
Code List
D. Myocardial Infarction
CL Item
Myocardial 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
Juvenile Twave pattern, early repolarization (D22)
CL Item
Other myocardial infarction (D98)
D. Myocardial Infarction - Comment
Item
D. Myocardial Infarction - Comment
text
C0027051 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
E. Depolarisation/Repolarisation (QRS-T)
text
C1331539 (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
ST segment abnormality, not specified (D96)
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
T wave abnormality, not specified (D97)
CL Item
Other depolarisation/repolarisation (D99)
E. Depolarisation/Repolarisation (QRS-T) - Comment
Item
E. Depolarisation/Repolarisation (QRS-T) - Comment
text
C1331539 (UMLS CUI [1,1])
C0948857 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
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 [1,3])
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