ID
31957
Description
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
Keywords
Versions (5)
- 10/9/18 10/9/18 -
- 10/9/18 10/9/18 - Julian Varghese
- 10/10/18 10/10/18 -
- 10/10/18 10/10/18 -
- 12/14/18 12/14/18 -
Copyright Holder
GSK group of companies
Uploaded on
October 9, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Extension balance and metabolic disposition of vilanterol as a single oral dose
Follow-Up Forms
- StudyEvent: ODM
Description
Vital Signs Follow-Up
Description
e.g., 01 JAN 10
Data type
date
Description
e.g., 15 min
Data type
integer
Description
e.g., 13:02
Data type
time
Description
Supine
Data type
integer
Measurement units
- mmHg
Description
Supine
Data type
integer
Measurement units
- mmHg
Description
Heart rate
Data type
integer
Measurement units
- bpm
Description
oral
Data type
float
Measurement units
- °C
Description
12 LEAD ECG Follow-Up
Description
Start date of ECG
Data type
date
Description
Planned Relative Time
Data type
text
Description
Start Time of ECG
Data type
time
Description
Ventricular Rate
Data type
integer
Measurement units
- bpm
Description
PR Interval
Data type
integer
Measurement units
- msec
Description
QRS Duration
Data type
integer
Measurement units
- msec
Description
Uncorrected QT Interval
Data type
integer
Measurement units
- msec
Description
QTc Invertal
Data type
integer
Measurement units
- msec
Description
Enter code for result from the following list: 1=Normal 2=Abnormal - not clinically significant 3=Abnormal - clinically significant 4=No result (not available)
Data type
integer
Description
12 LEAD ECG Abnormalities Follow-Up
Description
Date of ECG
Data type
date
Description
Time of ECG
Data type
time
Description
Rhythm
Data type
integer
Description
P-Wave and QRS Morphology
Data type
integer
Description
Conduction
Data type
integer
Description
Myocardial Infraction
Data type
integer
Description
Depolarisation/Repolarisation (QRS-T)
Data type
integer
Description
Other abnormalities
Data type
integer
Description
Electronically transferred laboratory data Follow-Up
Description
Pharmacogenetic (PGx) Research
Description
Consent for PGx Research
Data type
text
Description
Has consent been obtained for PGx Research?
Data type
boolean
Description
If YES, record the date informed consent obtained for PGx Research
Data type
date
Description
If NO, choose ONE reason:
Data type
text
Description
Sample collection
Data type
text
Description
Has a Sample been collected for PGx Research?
Data type
boolean
Description
If YES, record a date sample taken
Data type
date
Description
Has subject withdrawn consent for PGx Research?
Data type
boolean
Description
If YES, record the date informed consentwithdrawn for PGx research
Data type
date
Description
Has a request been made for sample destruction?
Data type
boolean
Description
If YES, choose one reason:
Data type
text
Description
Concomitant medications Follow-Up
Description
Were any concomitant medications taken by the subject during the study?
Data type
boolean
Description
if YES, record each medication on a separate line using Trade Names where possible
Data type
text
Description
Trade Name preferred e.g, Aspirin
Data type
integer
Description
e.g., 200
Data type
integer
Description
e.g., mg
Data type
integer
Description
e.g., BID
Data type
integer
Description
e.g., PO
Data type
integer
Description
e.g., Headache
Data type
text
Description
e.g., 31 MAY 08
Data type
date
Description
e.g., 14:10
Data type
time
Description
Taken prior to Study?
Data type
boolean
Description
e.g., 30 MAY 08
Data type
date
Description
e.g.,23:00
Data type
time
Description
Ongoing Medication
Data type
boolean
Description
Non-Serious Adverse Events
Description
If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form. If YES record details below
Data type
boolean
Description
Diagnosis only (if known)Otherwise Sign/Symptom e.g., Headache
Data type
text
Description
e.g., 25 JAN 09
Data type
date
Description
e.g., 13:25
Data type
time
Description
1=Recovered/Resolved 2=Recovering/Resolving 3=Not recovered/not resolved 4=Recovered/Resolved with sequelae e.g., 1
Data type
integer
Description
e.g., 27 JAN 09
Data type
date
Description
e.g., 10:20
Data type
time
Description
1=Single episode 2=Intermittent e.g., 1
Data type
integer
Description
1=Mild 2=Moderate 3=Severe X=Not applicable e.g., 1
Data type
integer
Description
1=Investigational product(s) withdrawn 2=Dose reduced 3=Dose increased 4=Dose not changed 5=Dos interrupted X=not applicable e.g., 4
Data type
integer
Description
Did the subject withdraw from study as a result of this AE?
Data type
boolean
Description
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Data type
boolean
Description
Serious Adverse Events (SAE)
Description
if YES record details below
Data type
boolean
Description
SECTION 1
Data type
text
Description
Diagnosis only (if known) Otherwise Sign/Symptom e.g., Anaphylaxis
Data type
text
Description
e.g., 25 JAN 09
Data type
date
Description
e.g., 13:25
Data type
time
Description
1=Recovered/Resolved 2=Recovering/Resolving 3=Not recovered/Not resolved 4=Recovered/Resolved with sequelae 5=Fatal e.g., 1
Data type
integer
Description
e.g., 27 JAN 09
Data type
date
Description
e.g, 10:20
Data type
time
Description
1=Mild 2=Moderate 3=Severe X=Not applicable
Data type
integer
Description
1=Investigational product(s) withdrawn 2=Dose reduced 3=Dose increased 4=Dose not changed 5=Dose interrupted X=Not applicable
Data type
integer
Description
Did the subject withdraw from study as a result of this SAE?
Data type
boolean
Description
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Data type
boolean
Description
if YES, summarise findings
Data type
boolean
Description
SECTION 2
Data type
text
Description
specify reason(s) for considering this a SAE, and tick all that apply:
Data type
text
Description
SECTION 3 Demography Data
Data type
text
Description
Date of Birth
Data type
date
Description
Sex
Data type
text
Description
Weight
Data type
float
Measurement units
- kg
Description
SECTION 4
Data type
text
Description
If investigational product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
Data type
text
Description
mark all that apply:
Data type
text
Description
SECTION 6 RELEVANT Medical Conditions
Data type
text
Description
Ensure each medical condition recorded in this section is also recorded in the appropriate Medical Condition form
Data type
text
Description
Date of onset
Data type
date
Description
Condition Present at Time of the SAE?
Data type
boolean
Description
If NO, Date of Last Occurrence
Data type
date
Description
Provide any family history or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE. Ensure each risk factor recorded in this section is also recorded in the appropriate Medical Conditions form
Data type
text
Description
Include details of any concomitant medication(s) that may help explain the SAE, may have caused the SAE or was used to treat the SAE. Ensure each risk factor recorded in this section is also recorded in the appropriate Medical Conditions form
Data type
text
Description
Trade Name preferred e.g., Zantac
Data type
text
Description
e.g., 150
Data type
text
Description
e.g., mg
Data type
float
Description
e.g., BID
Data type
float
Description
Route
Data type
text
Description
Taken prior to study?
Data type
boolean
Description
e.g., 25 JAN 09
Data type
date
Description
27 JAN 09
Data type
date
Description
Ongoing Medication?
Data type
boolean
Description
e.g., Gastric ulcer
Data type
text
Description
SECTION 9 Details of Investigational Product(s)
Data type
text
Description
Provide detailsn of any tests or procedures carried out to diagnose or confirm the SAE (e.g., laboratory data with units and normal range) of data for this SAE have not been previously entered, and the CRF includes a page for the test, ensure the data is also entered on the page
Data type
text
Description
Provide a brief narrative description of the SAE and details of treatment given
Data type
text
Description
Confirming that the data on the SAE pages are accurate and complete
Data type
text
Description
Investigator's name (print)
Data type
text
Description
Date
Data type
date
Similar models
Follow-Up Forms
- StudyEvent: ODM