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Information:
Fel:
ID
31967
Beskrivning
Study ID: 106181 Clinical Study ID: B2C106181 Study Title: An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01286831 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: vilanterol Trade Name: Study Indication: Pulmonary Disease, Chronic Obstructive
Nyckelord
Versioner (5)
- 2018-10-09 2018-10-09 -
- 2018-10-09 2018-10-09 - Julian Varghese
- 2018-10-10 2018-10-10 -
- 2018-10-10 2018-10-10 -
- 2018-12-14 2018-12-14 -
Rättsinnehavare
GSK group of companies
Uppladdad den
9 oktober 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Extension balance and metabolic disposition of vilanterol as a single oral dose
Similar models
Follow-Up Forms
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Concomitant medications
Item
Concomitant medications
text
Adverse Events
Item
Adverse Events
text
Physical Examination
Item
Physical Examination
text
Date of Assessment
Item
Date of Assessment
date
Skin
Item
Skin
boolean
Lungs
Item
Lungs
boolean
Cardiovascular
Item
Cardiovascular
boolean
Abdomen (Liver and Spleen)
Item
Abdomen (Liver and Spleen)
boolean
Date
Item
Date
date
CL Item
Follow-Up (1)
Actual Time
Item
Actual Time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart rate
Item
Heart rate
integer
Temperature
Item
Temperature
float
Start date of ECG
Item
Start date of ECG
date
CL Item
ECG 1 Follow UP (1)
CL Item
ECG 2 Unscheduled (2)
CL Item
ECG 3 Unscheduled (3)
Start Time of ECG
Item
Start Time of ECG
time
Ventricular Rate
Item
Ventricular Rate
integer
PR Interval
Item
PR Interval
integer
QRS Duration
Item
QRS Duration
integer
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
QTc Invertal
Item
QTc Invertal
integer
Result of the ECG
Item
Result of the ECG
integer
Date of ECG
Item
Date of ECG
date
Time of ECG
Item
Time of ECG
time
CL Item
[A 1] Sinus bradycardia (1)
CL Item
[A21] Sinus bradycardia (heart rate 40-50 beats/min) (2)
CL Item
[A22] Sinus bradycardia (heart rate 30-39 beats/min) (3)
CL Item
[A23] Sinus bradycardia (heart rate < 30 beats/min) (4)
CL Item
[A 3] Sinus pause (5)
CL Item
[A 2] Sinus tachycardia (6)
CL Item
[A 4] Ectropic supraventricular beats (7)
CL Item
[A20] Ectropic supraventricular rythm (8)
CL Item
[A17] Wandering atrial pacemaker (9)
CL Item
[A26] Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate > 100 beats/min) (10)
CL Item
[A 6] Supraventricular tachycardia (Heart rate > 100 beats/min) (11)
CL Item
[A 7] Atrial flutter (12)
CL Item
[A 8] Atrial fibrillation (13)
CL Item
[A 5] Junctional rhythm (heart rate <100 beats/min) (14)
CL Item
[A25] Junctional rhythm (15)
CL Item
[A24] Junctional tachycardia (heart rate > 100 beats/min) (16)
CL Item
[A 9] Ectopic ventricular beats (17)
CL Item
[B 3] right ventricular hypertrophy (1)
CL Item
[B 5] Intraatrial conduction delay (2)
CL Item
[B 7] Poor R wave progression (3)
CL Item
[B 9] Left atrial abnormality (4)
CL Item
[B10] Right atrial abnormality (5)
CL Item
[A12] Ventricular couplets (6)
CL Item
[A13] Bigeminy (7)
CL Item
[A28] Trigeminy (8)
CL Item
[A14] Electrical alternans (9)
CL Item
[A29] R on T phenomenon (10)
CL Item
[A18] Ventricular vebrilation (11)
CL Item
[A19] Indioventricular rhythm (heart rate < 100 bpm) (12)
CL Item
[A10] Sustained ventricular tachycardia (13)
CL Item
[A11] Non-sustained ventricular tachycardia (14)
CL Item
[A33] Sinus arrhythmia (15)
CL Item
[A33] Sinus arrhythmia (15)
CL Item
[A27] Ventricular tachycardia (16)
CL Item
[A30] Monomorphic ventricular tachycardia (17)
CL Item
[A15] Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (18)
CL Item
[A31] Polymorphic (sustained and non-sustained) ventricular tachycardia (19)
CL Item
[A16] Artificial pacemaker (20)
CL Item
[A35] Atrial premature complex (21)
CL Item
[A99]Other abnormal rhythm (22)
CL Item
[B16] Late R wave transition (23)
CL Item
[D14] Increased voltage consistent with left ventricular hypertrophy (24)
CL Item
[B99] Other morphology (25)
CL Item
[C 1] First degree AV block (PR interval > 200 msec) (1)
CL Item
[C20] Short PR interval (2)
CL Item
[C 2] Second degree AV block (Mobitz type 1) (3)
CL Item
[C 3] Second degree AV block (Mobitz type 2) (4)
CL Item
[C16] 2:1 AV block (5)
CL Item
[C 4] Third degree AV block (6)
CL Item
[C 5] Left axis deviation (QRS axis more negative than -30°) (7)
CL Item
[C 6] Right axis deviation (QRS axis more positive than +110°) (8)
CL Item
[C 7] Incomplete right bundle branch block (9)
CL Item
[C13] Incomplete left bundle branch block (10)
CL Item
[C 8] Right bundle branch block (11)
CL Item
[C 14] Left anterior hemiblock (synonymous to left anterior fascicular block) (12)
CL Item
[D 1] Myocardial infraction, old (1)
CL Item
[D 2] Myocardial infraction, anterior (2)
CL Item
[D 3] Myocardial infraction, lateral (3)
CL Item
[D 4] Myocardial infraction, posterior (4)
CL Item
[D 5] Myocardial infraction, inferior (5)
CL Item
[D 7] Non-specific ST-T changes (1)
CL Item
[D19] J point elevation (2)
CL Item
[D 8] ST elevation (3)
CL Item
[D21] ST elevation-pericarditis (4)
CL Item
[D 9] ST depression (5)
CL Item
[D96] ST segment abnormality, not specified (6)
CL Item
[D10] U waves abnormal (7)
CL Item
[D11] T wave inversion (8)
CL Item
[D12] T wave peaked (9)
CL Item
[E99] Other abnormalities (1)
CL Item
[C15] Left posterior hemiblock (synonymous to left posterior fascicular block) (2)
CL Item
[C 9] Left bundle branch block (3)
CL Item
[C17] Bifascicular block (4)
CL Item
[C10] Non-specific intraventricular conduction delay (QRS>120msec) (5)
CL Item
[C11] Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (6)
CL Item
[C18] AV dissociation (7)
CL Item
[C28] Prolonged QT 450-500 (8)
CL Item
[C29] Prolonged QT >500 (9)
CL Item
[C30] Prolonged QTc Interval 450-500 (10)
CL Item
[C31] Prolonged QTc Interval >500 (11)
CL Item
[C99] Other conduction (12)
CL Item
[D 6] Myocardial infraction, septal (13)
CL Item
[D20] Myocardial infraction, Non-Q wave (14)
CL Item
[D08] Other myocardial infraction (15)
CL Item
[D15] T waves flat (16)
CL Item
[D16] T waves biphasic (17)
CL Item
[D18] Notched T-waves (18)
CL Item
[D13] Low QRS voltage (19)
CL Item
[D17] T-wave flattening/inversion (20)
CL Item
[D22] Juvenile T wave pattern, early repolarization (21)
CL Item
[D97] T wave abnormality, not specified (22)
CL Item
[D99] Other depolarization/repolarization (23)
Item Group
Electronically transferred laboratory data Follow-Up
Clinical chemistry
Item
Clinical chemistry
datetime
Haematology
Item
Haematology
datetime
Urinalisys
Item
Urinalisys
datetime
Consent for PGx Research
Item
Consent for PGx Research
text
Has consent been obtained for PGx Research?
Item
Has consent been obtained for PGx Research?
boolean
If YES, record the date informed consent obtained for PGx Research
Item
If YES, record the date informed consent obtained for PGx Research
date
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify_______________ (3)
Sample collection
Item
Sample collection
text
Has a Sample been collected for PGx Research?
Item
Has a Sample been collected for PGx Research?
boolean
If YES, record a date sample taken
Item
If YES, record a date sample taken
date
Withdrawal of consent
Item
Withdrawal of consent
boolean
If YES, record the date informed consentwithdrawn for PGx research
Item
If YES, record the date informed consentwithdrawn for PGx research
date
Sample destruction
Item
Sample destruction
boolean
CL Item
[1] Subject requested (1)
CL Item
[z] Other, specify_____________ (2)
Were any concomitant medications taken by the subject during the study?
Item
Were any concomitant medications taken by the subject during the study?
boolean
if YES, record each medication on a separate line using Trade Names where possible
Item
if YES, record each medication on a separate line using Trade Names where possible
text
Drug name
Item
Drug name
integer
Unit dose
Item
Unit dose
integer
Units
Item
Units
integer
Frequency
Item
Frequency
integer
Route
Item
Route
integer
Reason for Medication
Item
Reason for Medication
text
Start Date
Item
Start Date
date
Start Time
Item
Start Time
time
Taken prior to Study?
Item
Taken prior to Study?
boolean
Stop Date
Item
Stop Date
date
Stop Time
Item
Stop Time
time
Ongoing Medication
Item
Ongoing Medication
boolean
Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any non-serious adverse events during the study?
boolean
Event
Item
Event
text
Start Date
Item
Start Date
date
Start Time
Item
Start Time
time
Outcome
Item
Outcome
integer
End Date
Item
End Date
date
End Time
Item
End Time
time
Frequency
Item
Frequency
integer
Maximum Intensity
Item
Maximum Intensity
integer
Action taken with Investigational Product(s) as a Result of the Non-Serious AE
Item
Action taken with Investigational Product(s) as a Result of the Non-Serious AE
integer
Withdrawal
Item
Withdrawal
boolean
Relationship to Investigational Product(s)
Item
Relationship to Investigational Product(s)
boolean
Did the subject experience a SAE during the study?
Item
Did the subject experience a SAE during the study?
boolean
SECTION 1
Item
SECTION 1
text
Event
Item
Event
text
Start Date
Item
Start Date
date
Start Time
Item
Start Time
time
Outcome
Item
Outcome
integer
End Date
Item
End Date
date
End Time
Item
End Time
time
Maximum Intensity
Item
Maximum Intensity
integer
Action taken with Investigational Product(s) as a result of the SAE
Item
Action taken with Investigational Product(s) as a result of the SAE
integer
Withdrawal
Item
Withdrawal
boolean
Relationship to Investigational Product(s)
Item
Relationship to Investigational Product(s)
boolean
if FATAL, was a post-mortem/autopsy performed
Item
if FATAL, was a post-mortem/autopsy performed
boolean
SECTION 2
Item
SECTION 2
text
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other, specify______________________________ (6)
CL Item
Liver injury and impaired liver function (7)
SECTION 3 Demography Data
Item
SECTION 3 Demography Data
text
Date of Birth
Item
Date of Birth
date
CL Item
Male (1)
CL Item
Female (2)
Weight
Item
Weight
float
SECTION 4
Item
SECTION 4
text
Item
If investigational product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
Code List
If investigational product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item
SECTION 5 Possible causes of SAE other than Investigational Product(s)
text
Code List
SECTION 5 Possible causes of SAE other than Investigational Product(s)
CL Item
Disease under study (1)
CL Item
Medical condition(s) specify______________________ (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication(s) specify________________ (5)
CL Item
Activity related to study participation (e.g., procedures) (6)
CL Item
Other, specify ________________________________ (7)
SECTION 6 RELEVANT Medical Conditions
Item
SECTION 6 RELEVANT Medical Conditions
text
Specify any RELEVANT past or present medical disorders, allergies, surgeries that can help explain the SAE.
Item
Specify any RELEVANT past or present medical disorders, allergies, surgeries that can help explain the SAE.
text
Date of onset
Item
Date of onset
date
Condition Present at Time of the SAE?
Item
Condition Present at Time of the SAE?
boolean
If NO, Date of Last Occurrence
Item
If NO, Date of Last Occurrence
date
SECTION 7 Other relevant risk factors
Item
SECTION 7 Other relevant risk factors
text
SECTION 8 RELEVANT concomitant medications
Item
SECTION 8 RELEVANT concomitant medications
text
Drug Name
Item
Drug Name
text
Dose
Item
Dose
text
Unit
Item
Unit
float
Frequency
Item
Frequency
float
Route
Item
Route
text
Taken prior to study?
Item
Taken prior to study?
boolean
Start Date
Item
Start Date
date
Stop Date
Item
Stop Date
date
Ongoing Medication?
Item
Ongoing Medication?
boolean
Reason for Medication
Item
Reason for Medication
text
SECTION 9 Details of Investigational Product(s)
Item
SECTION 9 Details of Investigational Product(s)
text
SECTION 10 Details of RELEVANT assessments
Item
SECTION 10 Details of RELEVANT assessments
text
SECTION 11 Narrative Remarks
Item
SECTION 11 Narrative Remarks
text
Investigator's signature
Item
Investigator's signature
text
Investigator's name (print)
Item
Investigator's name (print)
text
Date
Item
Date
date