ID

35451

Description

Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Keywords

Versions (2)
  1. 2/25/19 2/25/19 -
  2. 3/4/19 3/4/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 4, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

English

12-Lead ECG Abnormalities

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

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

12-Lead ECG Abnormalities

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

12 lead ECG, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
Time of ECG
Description

12 lead ECG, Time

Data type

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0040223
Rhythm
Description

12 lead ECG, Abnormality, Electrocardiogram: Rhythm

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0199556
Comment
Description

12 lead ECG, Abnormality, Electrocardiogram: Rhythm, Comment

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0199556
UMLS CUI [1,4]
C0947611
P-Wave and QRS Morphology
Description

12 lead ECG, Abnormality, electrocardiogram: P wave shifting morphology;12 lead ECG, Abnormality, Electrocardiogram QRS complex

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2216025
UMLS CUI [2,1]
C0430456
UMLS CUI [2,2]
C1704258
UMLS CUI [2,3]
C0429098
Comment
Description

12 lead ECG, Abnormality, electrocardiogram: P wave shifting morphology, Comment; 12 lead ECG, Abnormality, Electrocardiogram QRS complex, Comment

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2216025
UMLS CUI [1,4]
C0947611
UMLS CUI [2,1]
C0430456
UMLS CUI [2,2]
C1704258
UMLS CUI [2,3]
C0429098
UMLS CUI [2,4]
C0947611
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
Comment
Description

12 lead ECG, Abnormality, Cardiac Conduction, Comment

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0232217
UMLS CUI [1,4]
C0947611
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
Comment
Description

12 lead ECG, Abnormality, Myocardial Infarction, Comment

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0027051
UMLS CUI [1,4]
C0947611
Depolarisation/Repolarisation (QRS-T)
Description

12 lead ECG, Abnormality, Ventricular Depolarization [PE]; 12 lead ECG, Abnormality, Electrocardiogram repolarisation abnormality

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C1331539
UMLS CUI [2,1]
C0430456
UMLS CUI [2,2]
C1704258
UMLS CUI [2,3]
C0948857
Comment
Description

12 lead ECG, Abnormality, Ventricular Depolarization [PE], Comment; 12 lead ECG, Abnormality, Electrocardiogram repolarisation abnormality, Comment

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C1331539
UMLS CUI [1,4]
C0947611
UMLS CUI [2,1]
C0430456
UMLS CUI [2,2]
C1704258
UMLS CUI [2,3]
C0948857
UMLS CUI [2,4]
C0947611
Other abnormalities
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
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
12-Lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
12 lead ECG, Date in time
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
12 lead ECG, Time
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Rhythm
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
A. Rhythm
Code List
Rhythm
CL Item
[A1] Sinus bradycardia (1)
CL Item
[A21] Sinus bradycardia (heart rate 40-50 bpm) (2)
CL Item
[A22] Sinus bradycardia (heart rate 30-39 bpm) (3)
CL Item
[A23] Sinus bradycardia (heart rate <30 bpm) (4)
CL Item
[A3] Sinus pause (5)
CL Item
[A2] Sinus tachycardia (heart rate >100 bpm) (6)
CL Item
[A4] Ectopic supraventricular beats (7)
CL Item
[A20] Ectopic supraventricular rhythm (8)
CL Item
[A17] Wandering atrial pacemaker (9)
CL Item
[A26] Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 bpm) (10)
CL Item
[A6] Supraventricular tachycardia (heart rate >100 bpm) (11)
CL Item
[A7] Atrial flutter (12)
CL Item
[A8] Atrial fibrillation (13)
CL Item
[A5] Junctional rhythm (heart rate <=100 bpm) (14)
CL Item
[A25] Junctional rhythm (15)
CL Item
[A24] Junctional tachycardia (heart rate > 100 bpm) (16)
CL Item
[A9] Ectopic ventricular beats (17)
CL Item
[A12] Ventricular couplets (18)
CL Item
[A13] Bigeminy (19)
CL Item
[A28] Trigeminy (20)
CL Item
[A14] Electrical alternans (21)
CL Item
[A29] R on T phenomenon (22)
CL Item
[A18] Ventricular fibrillation (23)
CL Item
[A19] Idioventricular rhythm (heart rate < 100 bpm) (24)
CL Item
[A10] Sustained ventricular tachycardia (25)
CL Item
[A11] Non-sustained ventricular tachycardia (26)
CL Item
[A32] Wide QRS Tachycardia (diagnosis unknown) (27)
CL Item
[A27] Ventricular tachycardia (28)
CL Item
[A30] Monomorphic ventricular tachycardia (29)
CL Item
[A15] Torsades de Pointes (Polymosphic ventricular tachycardia with prolonged QT) (30)
CL Item
[A31] Polymorphic (sustained and non-sustained) ventricular tachycardia (31)
CL Item
[A16] Artificial pacemaker (32)
CL Item
[A99] Other abnormal rhythm (33)
12 lead ECG, Abnormality, Electrocardiogram: Rhythm, Comment
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
Item
P-Wave and QRS Morphology
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
C0430456 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0429098 (UMLS CUI [2,3])
B. P-Wave and QRS Morphology
Code List
P-Wave and QRS Morphology
CL Item
[B1] Left atrial abnormality (P mitrale) (1)
CL Item
[B2] Rightatrial abnormality (P pulmonale) (2)
CL Item
[B3] Right ventricular hypertrophy (3)
CL Item
[B5] Intraatrial conduction delay (4)
CL Item
[B14] Increased voltage consistent with left ventricular hypertrophy (5)
CL Item
[B99] Other morphology (6)
12 lead ECG, Abnormality, electrocardiogram: P wave shifting morphology, Comment; 12 lead ECG, Abnormality, Electrocardiogram QRS complex, Comment
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0430456 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0429098 (UMLS CUI [2,3])
C0947611 (UMLS CUI [2,4])
Item
Conduction
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
C. Conduction
Code List
Conduction
CL Item
[C1] First degree AV block (PR interval > 200 msec) (1)
CL Item
[C20] Short PR interval (2)
CL Item
[C2] Second degree AV block (Mobitz type 1) (3)
CL Item
[C3] Second degree AV block (Mobitz type 2) (4)
CL Item
[C16] 2:1 AV block (5)
CL Item
[C4] Third degree AV block (6)
CL Item
[C5] Left axis deviation (QRS axis more negative than -30°) (7)
CL Item
[C6] Right axis deviation (QRS axis more positive than +110°) (8)
CL Item
[C7] Incomplete right bundle branch block (9)
CL Item
[C13] Incomplete left bundle branch block (10)
CL Item
[C8] Right bundle branch block (11)
CL Item
[C14] Left anterior hemiblock (synonymous to left anterior fascicular block) (12)
CL Item
[C15] Left posterior hemiblock (synonymous to left posterior fascicular block) (13)
CL Item
[C9] Left bundle branch block (14)
CL Item
[C17] Bifascicular block (15)
CL Item
[C10] Non-specific intraventricular conduction delay (QRS >=120msec) (16)
CL Item
[C11] Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (17)
CL Item
[C19] Prolonged QT interval (18)
CL Item
[C12] QT/QTc prolongation >=500 msec (19)
CL Item
[C18] AV dissociation (20)
CL Item
[C99] Other conduction  (21)
12 lead ECG, Abnormality, Cardiac Conduction, Comment
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
Item
Myocardial Infarction
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
D. Myocardial Infraction
Code List
Myocardial Infarction
CL Item
[D1] Myocardial infarction, old (1)
CL Item
[D2] Myocardial infarction, anterior (2)
CL Item
[D3] Myocardial infarction, lateral (3)
CL Item
[D4] Myocardial infarction, posterior (4)
CL Item
[D5] Myocardial infarction, inferior (5)
CL Item
[D6] Myocardial infarction, septal (6)
CL Item
[D20] Myocardial infarction, Non-Q wave (7)
CL Item
[D98] Other myocardial infarction  (8)
12 lead ECG, Abnormality, Myocardial Infarction, Comment
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
Item
Depolarisation/Repolarisation (QRS-T)
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0430456 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0948857 (UMLS CUI [2,3])
E. Depolarisation/Repolarisation (QRS-T)
Code List
Depolarisation/Repolarisation (QRS-T)
CL Item
[D7] Non-specific ST-T changes (1)
CL Item
[D19] J point elevation (2)
CL Item
[D8] ST elevation (3)
CL Item
[D21] ST elevation-pericarditis (4)
CL Item
[D9] ST depression (5)
CL Item
[D10] U waves abnormal (6)
CL Item
[D11] T wave inversion (7)
CL Item
[D12] T wave peaked (8)
CL Item
[D15] T waves flat (9)
CL Item
[D16] T waves biphasic (10)
CL Item
[D18] Notched T-waves (11)
CL Item
[D13] Low QRS voltage (12)
CL Item
[D17] T-wave flattening/inversion (13)
CL Item
[D99] Other depolarisation/repolarisation  (14)
12 lead ECG, Abnormality, Ventricular Depolarization [PE], Comment; 12 lead ECG, Abnormality, Electrocardiogram repolarisation abnormality, Comment
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0430456 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0948857 (UMLS CUI [2,3])
C0947611 (UMLS CUI [2,4])
Item
Other abnormalities
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Other abnormalities
Code List
Other abnormalities
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