ID
31975
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
10 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. 106181
Follow-Up Forms
- StudyEvent: ODM
Beskrivning
Vital Signs Follow-Up
Beskrivning
e.g., 01 JAN 10
Datatyp
date
Beskrivning
e.g., 15 min
Datatyp
integer
Beskrivning
e.g., 13:02
Datatyp
time
Beskrivning
Supine
Datatyp
integer
Måttenheter
- mmHg
Beskrivning
Supine
Datatyp
integer
Måttenheter
- mmHg
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- bpm
Beskrivning
oral
Datatyp
float
Måttenheter
- °C
Beskrivning
12 LEAD ECG Follow-Up
Beskrivning
Start date of ECG
Datatyp
date
Beskrivning
Planned Relative Time
Datatyp
text
Beskrivning
Start Time of ECG
Datatyp
time
Beskrivning
Ventricular Rate
Datatyp
integer
Måttenheter
- bpm
Beskrivning
PR Interval
Datatyp
integer
Måttenheter
- msec
Beskrivning
QRS Duration
Datatyp
integer
Måttenheter
- msec
Beskrivning
Uncorrected QT Interval
Datatyp
integer
Måttenheter
- msec
Beskrivning
QTc Invertal
Datatyp
integer
Måttenheter
- msec
Beskrivning
Enter code for result from the following list: 1=Normal 2=Abnormal - not clinically significant 3=Abnormal - clinically significant 4=No result (not available)
Datatyp
integer
Beskrivning
12 LEAD ECG Abnormalities Follow-Up
Beskrivning
Date of ECG
Datatyp
date
Beskrivning
Time of ECG
Datatyp
time
Beskrivning
Rhythm
Datatyp
integer
Beskrivning
P-Wave and QRS Morphology
Datatyp
integer
Beskrivning
Conduction
Datatyp
integer
Beskrivning
Myocardial Infraction
Datatyp
integer
Beskrivning
Depolarisation/Repolarisation (QRS-T)
Datatyp
integer
Beskrivning
Other abnormalities
Datatyp
integer
Beskrivning
Electronically transferred laboratory data Follow-Up
Beskrivning
Pharmacogenetic (PGx) Research
Beskrivning
Consent for PGx Research
Datatyp
text
Beskrivning
Has consent been obtained for PGx Research?
Datatyp
boolean
Beskrivning
If YES, record the date informed consent obtained for PGx Research
Datatyp
date
Beskrivning
If NO, choose ONE reason:
Datatyp
text
Beskrivning
Sample collection
Datatyp
text
Beskrivning
Has a Sample been collected for PGx Research?
Datatyp
boolean
Beskrivning
If YES, record a date sample taken
Datatyp
date
Beskrivning
Has subject withdrawn consent for PGx Research?
Datatyp
boolean
Beskrivning
If YES, record the date informed consentwithdrawn for PGx research
Datatyp
date
Beskrivning
Has a request been made for sample destruction?
Datatyp
boolean
Beskrivning
If YES, choose one reason:
Datatyp
text
Beskrivning
Concomitant medications Follow-Up
Beskrivning
Were any concomitant medications taken by the subject during the study?
Datatyp
boolean
Beskrivning
if YES, record each medication on a separate line using Trade Names where possible
Datatyp
text
Beskrivning
Trade Name preferred e.g, Aspirin
Datatyp
integer
Beskrivning
e.g., 200
Datatyp
integer
Beskrivning
e.g., mg
Datatyp
integer
Beskrivning
e.g., BID
Datatyp
integer
Beskrivning
e.g., PO
Datatyp
integer
Beskrivning
e.g., Headache
Datatyp
text
Beskrivning
e.g., 31 MAY 08
Datatyp
date
Beskrivning
e.g., 14:10
Datatyp
time
Beskrivning
Taken prior to Study?
Datatyp
boolean
Beskrivning
e.g., 30 MAY 08
Datatyp
date
Beskrivning
e.g.,23:00
Datatyp
time
Beskrivning
Ongoing Medication
Datatyp
boolean
Beskrivning
Non-Serious Adverse Events
Beskrivning
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
Datatyp
boolean
Beskrivning
Diagnosis only (if known)Otherwise Sign/Symptom e.g., Headache
Datatyp
text
Beskrivning
e.g., 25 JAN 09
Datatyp
date
Beskrivning
e.g., 13:25
Datatyp
time
Beskrivning
1=Recovered/Resolved 2=Recovering/Resolving 3=Not recovered/not resolved 4=Recovered/Resolved with sequelae e.g., 1
Datatyp
integer
Beskrivning
e.g., 27 JAN 09
Datatyp
date
Beskrivning
e.g., 10:20
Datatyp
time
Beskrivning
1=Single episode 2=Intermittent e.g., 1
Datatyp
integer
Beskrivning
1=Mild 2=Moderate 3=Severe X=Not applicable e.g., 1
Datatyp
integer
Beskrivning
1=Investigational product(s) withdrawn 2=Dose reduced 3=Dose increased 4=Dose not changed 5=Dos interrupted X=not applicable e.g., 4
Datatyp
integer
Beskrivning
Did the subject withdraw from study as a result of this AE?
Datatyp
boolean
Beskrivning
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Datatyp
boolean
Beskrivning
Serious Adverse Events (SAE)
Beskrivning
if YES record details below
Datatyp
boolean
Beskrivning
SECTION 1
Datatyp
text
Beskrivning
Diagnosis only (if known) Otherwise Sign/Symptom e.g., Anaphylaxis
Datatyp
text
Beskrivning
e.g., 25 JAN 09
Datatyp
date
Beskrivning
e.g., 13:25
Datatyp
time
Beskrivning
1=Recovered/Resolved 2=Recovering/Resolving 3=Not recovered/Not resolved 4=Recovered/Resolved with sequelae 5=Fatal e.g., 1
Datatyp
integer
Beskrivning
e.g., 27 JAN 09
Datatyp
date
Beskrivning
e.g, 10:20
Datatyp
time
Beskrivning
1=Mild 2=Moderate 3=Severe X=Not applicable
Datatyp
integer
Beskrivning
1=Investigational product(s) withdrawn 2=Dose reduced 3=Dose increased 4=Dose not changed 5=Dose interrupted X=Not applicable
Datatyp
integer
Beskrivning
Did the subject withdraw from study as a result of this SAE?
Datatyp
boolean
Beskrivning
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Datatyp
boolean
Beskrivning
if YES, summarise findings
Datatyp
boolean
Beskrivning
SECTION 2
Datatyp
text
Beskrivning
specify reason(s) for considering this a SAE, and tick all that apply:
Datatyp
text
Beskrivning
SECTION 3 Demography Data
Datatyp
text
Beskrivning
Date of Birth
Datatyp
date
Beskrivning
Sex
Datatyp
text
Beskrivning
Weight
Datatyp
float
Måttenheter
- kg
Beskrivning
SECTION 4
Datatyp
text
Beskrivning
If investigational product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
Datatyp
text
Beskrivning
mark all that apply:
Datatyp
text
Beskrivning
SECTION 6 RELEVANT Medical Conditions
Datatyp
text
Beskrivning
Ensure each medical condition recorded in this section is also recorded in the appropriate Medical Condition form
Datatyp
text
Beskrivning
Date of onset
Datatyp
date
Beskrivning
Condition Present at Time of the SAE?
Datatyp
boolean
Beskrivning
If NO, Date of Last Occurrence
Datatyp
date
Beskrivning
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
Datatyp
text
Beskrivning
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
Datatyp
text
Beskrivning
Trade Name preferred e.g., Zantac
Datatyp
text
Beskrivning
e.g., 150
Datatyp
text
Beskrivning
e.g., mg
Datatyp
float
Beskrivning
e.g., BID
Datatyp
float
Beskrivning
Route
Datatyp
text
Beskrivning
Taken prior to study?
Datatyp
boolean
Beskrivning
e.g., 25 JAN 09
Datatyp
date
Beskrivning
27 JAN 09
Datatyp
date
Beskrivning
Ongoing Medication?
Datatyp
boolean
Beskrivning
e.g., Gastric ulcer
Datatyp
text
Beskrivning
SECTION 9 Details of Investigational Product(s)
Datatyp
text
Beskrivning
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
Datatyp
text
Beskrivning
Provide a brief narrative description of the SAE and details of treatment given
Datatyp
text
Beskrivning
Confirming that the data on the SAE pages are accurate and complete
Datatyp
text
Beskrivning
Investigator's name (print)
Datatyp
text
Beskrivning
Date
Datatyp
date
Similar models
Follow-Up Forms
- StudyEvent: ODM