ID

40426

Beskrivning

Study ID: 110792 Clinical Study ID: 110792 Study Title: A placebo-controlled, single-blind, randomised study to investigate the safety, tolerability, pharmacokinetics and drug interaction of GSK1034702 after repeat doses in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950586 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Dextromethorphan, Placebo Trade Name: N/A Study Indication: Cognitive Disorders

Nyckelord

D007753

Clinical Trial

Electrocardiogram (ECG)

Vitalzeichen

Memory Disorders

2020-04-19 2020-04-19 -

Rättsinnehavare

GlaxoSmithKline

Uppladdad den

19 april 2020

DOI

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Licens

Creative Commons BY-NC 4.0

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GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586

model
Detaljer

V7

1 Formulär

StudyEvent: ODM
1. V7

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Date of visit

Item Group

Date of Visit

C1320303 (UMLS CUI-1)

Date of visit, Assessment Date

Item

Date of visit/assessment

date

C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])

Cytochrome P450 2D6 Inhibitors [MoA], Status

Item Group

2D6 Status

C2962190 (UMLS CUI-1)
C0449438 (UMLS CUI-2)

Cytochrome P450 2D6 Inhibitors [MoA], Sampling, Date in time, Time

Item

Date and time sample taken

datetime

C2962190 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])

Cytochrome P450 2D6 Inhibitors [MoA], Status

Item

2D6 Status

text

C2962753 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])

Cytochrome P450 2D6 Inhibitors [MoA], Status

Code List

2D6 Status

CL Item

Extensive metabolizer (1)

CL Item

Poor metabolizer (2)

Dextromethorphan

Item Group

Dextromethorphan

C0011816 (UMLS CUI-1)

Dextromethorphan, Dosage, Date in time, Time

Item

Date/time of dose

datetime

C0011816 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])

Therapeutic procedure, Confirmation

Item Group

Treatment Confirmation

C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-2)

Therapeutic procedure, Confirmation

Item

Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during the dosing interval?

boolean

C0087111 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])

Therapeutic procedure, Wrong, Reason and justification

Item

No, record reason(s)

boolean

C0087111 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])

Blood Pressure Monitoring, Ambulatory

Item Group

ABPM

C0242876 (UMLS CUI-1)

Blood Pressure Monitoring, Ambulatory, Start Date, Start time

Item

Start date/time ambulatory blood pressure

datetime

C0242876 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])

Blood Pressure Monitoring, Ambulatory, End date, End Time

Item

End date/time ambulatory blood pressure

datetime

C0242876 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])

Cognitive functions, Tests

Item Group

CogState

C0392335 (UMLS CUI-1)
C0392366 (UMLS CUI-2)

Cognitive functions, Tests, Date in time, Time

Item

Test 1 - Date and time test taken

datetime

C0392335 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])

Cognitive functions, Tests, Date in time, Time

Item

Test 2 - Date and time test taken

datetime

C0392335 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])

Cognitive functions, Tests, Date in time, Time

Item

D-1 - Date and time test taken

datetime

C0392335 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])

Holter Electrocardiography

Item Group

Holter

C0013801 (UMLS CUI-1)

Holter Electrocardiography, Start Date, Start time

Item

Start Date and Time of Holter

datetime

C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])

Holter Electrocardiography, End date, End Time

Item

Stop Date and Time of Holter

datetime

C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])

Holter Electrocardiography, Clinical Interpretation

Item

Interpretation of Holter

text

C0013801 (UMLS CUI [1,1])
C4086187 (UMLS CUI [1,2])

Holter Electrocardiography, Clinical Interpretation

Code List

Interpretation of Holter

CL Item

Normal (1)

CL Item

Abnormal - Not clinically significant (2)

CL Item

Abnormal - Clinically significant (3)

CL Item

No result (4)

CL Item

Unable to evaluate (5)

Holter Electrocardiography, Abnormality

Item Group

Summary Holter Abnormalities

C0013801 (UMLS CUI-1)
C1704258 (UMLS CUI-2)

Holter Electrocardiography, Abnormality

Item

Record clinically significant abnormalities below - Check all that apply

text

C0013801 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])

Holter Electrocardiography, Abnormality

Code List

Record clinically significant abnormalities below - Check all that apply

CL Item

No abnormalities (1)

CL Item

Sinus bradycardia (50-59 beats/min) (2)

CL Item

Sinus bradycardia (40-49 beats/min) (3)

CL Item

Sinus bradycardia (30-39 beats/min) (4)

CL Item

Sinus bradycardia (<30 beats/min) (5)

CL Item

Sinus pause (6)

CL Item

Sinus tachycardia (>100 beats/min) (7)

CL Item

Ectopic supraventricular beats (8)

CL Item

Ectopic supraventricular rhythm (9)

CL Item

Wandering atrial pacemaker (10)

CL Item

Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (11)

CL Item

Non-sustained supraventricular tachycardia (>100 beats/min, 3-30 beats) (12)

CL Item

Sustained supraventricular tachycardia (>100 beats/min, >30 beats) (13)

CL Item

Atrial flutter (14)

CL Item

Atrial fibrillation (15)

CL Item

Junctional rhythm (<=100 beats/min, defined by narrow QRS complex) (16)

CL Item

Junctional tachycardia (>100 beats/min) (17)

CL Item

Ventricular premature deplorisation (18)

CL Item

Ventricular couplets (19)

CL Item

Bigeminy (20)

CL Item

Trigeminy (21)

CL Item

Electrical alternans (22)

CL Item

R on T phenomenon (23)

CL Item

Ventricular fibrillation (24)

CL Item

Idioventricular rhythm (<=100 beats/min, defined by wide QRS complex) (25)

CL Item

Non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (26)

CL Item

Sustained ventricular tachycardia (>100 beats/min, >30 beats) (27)

CL Item

Wide QRS tachycardia (diagnosis unknown (28)

CL Item

Monomorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (29)

CL Item

Monomorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (30)

CL Item

Polymorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (31)

CL Item

Polymorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (32)

CL Item

Torsades de Pointes (TdP) (33)

CL Item

Pacemaker (34)

CL Item

First degree AV block (PR interval >200msec) (35)

CL Item

Short PR Intervak (36)

CL Item

Second degree AV block (Mobitz type 1) (37)

CL Item

Second degree AV block (Mobitz type 2) (38)

CL Item

2:1 AV block (39)

CL Item

Third degree AV block (40)

CL Item

Left axis deviation (QRS axis more negative than -30 degrees) (41)

CL Item

Right axis deviation (QRS axis more positive than +100 degrees) (42)

CL Item

Incomplete left bundle branch block (43)

CL Item

Incomplete left bundle branch block (44)

CL Item

Right bundle branch block (45)

CL Item

Left anterior hemiblock (46)

CL Item

Left posterior hemiblock (47)

CL Item

Left bundle branch block (48)

CL Item

Bifascicular block (49)

CL Item

Non-specific intraventricular conduction delay (QRS >=120 msec) (50)

CL Item

Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-Levine (51)

CL Item

QTc prolongation >=500 msec (52)

CL Item

AV dissociation (53)

CL Item

Myocardial infarction, old (54)

CL Item

Myocardial infarction, non Q-wave (55)

CL Item

Non-specific ST-T changes (56)

CL Item

J point elevation (57)

CL Item

ST elevation (58)

CL Item

ST depression (59)

CL Item

ST segment abnormality (60)

CL Item

U waves (61)

CL Item

T wave inversion (62)

CL Item

T wave peaked (63)

CL Item

T waves biphasic (64)

CL Item

T waves flat (65)

CL Item

66)Notched T-waves (66)Notched T-waves)

CL Item

Low QRS voltage (67)

CL Item

T wave abnormality (68)

CL Item

Other abnormal rhythm (69)

CL Item

Other morphology (70)

CL Item

Other conduction (71)

CL Item

Other myocardial infarction (72)

CL Item

Other depolarization/repolarisation (73)

CL Item

Other abnormality/Cardiologist comments (74)

Laboratory Procedures

Item Group

Electronically Transferred Lab Data

C0022885 (UMLS CUI-1)

Laboratory Procedures, Hematology finding, Sampling, Date in time, Time

Item

Haematology Date and time sample taken

datetime

C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])

Laboratory Procedures, Hematology finding, Sampling, Not done

Item

Not done

boolean

C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,4])

Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time, Time

Item

Clinical Chemistry Date and time sample taken

datetime

C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])

Laboratory Procedures, Chemistry, Clinical, Sampling, Not done

Item

Not done

boolean

C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,4])

Laboratory Procedures, Urinalysis, Sampling, Date in time, Time

Item

Urinalysis Date and time sample taken

datetime

C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])

Laboratory Procedures, Urinalysis, Sampling, Not done

Item

Not done

datetime

C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,4])

Pharmacokinetic aspects, Blood

Item Group

Pharmacokinetics Blood

C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)

Pharmacokinetic aspects, Blood, Dosage, Date in time, Time

Item

Dosing date/time

datetime

C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])

Pharmacokinetic aspects, Blood, Time

Item

Pre-dose - Actual time

time