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ID
32116
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 (3)
- 10/18/18 10/18/18 -
- 12/27/18 12/27/18 -
- 3/4/19 3/4/19 -
Copyright Holder
GSK group of companies
Uploaded on
October 18, 2018
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
12-lead ECG Abnormalities Form
- StudyEvent: ODM
Similar models
12-lead ECG Abnormalities Form
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Subject Identifier
Item
Subject Identifier
integer
Date of ECG
Item
Date of ECG
date
Time of ECG
Item
Time of ECG
time
Item Group
Record clinically significant abnormalities below. Mark all that apply:
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)
Comment
Item
Comment
text
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)
Comment
Item
Comment
text
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)
Comment
Item
Comment
text
CL Item
[D1] Myocardial infraction, old (1)
CL Item
[D2] Myocardial infraction, anterior (2)
CL Item
[D3] Myocardial infraction, lateral (3)
CL Item
[D4] Myocardial infraction, posterior (4)
CL Item
[D5] Myocardial infraction, inferior (5)
CL Item
[D6] Myocardial infraction, septal (6)
CL Item
[D20] Myocardial infraction, Non-Q wave (7)
CL Item
[D98] Other myocardial infraction (8)
Comment
Item
Comment
text
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)
Comment
Item
Comment
text
CL Item
[E99] Other abnormalities (1)
Comment
Item
Comment
text