ID

31977

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 (3)
  1. 2018-10-09 2018-10-09 -
  2. 2018-10-10 2018-10-10 -
  3. 2018-11-21 2018-11-21 -
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

Engelsk

Study conclusion

1 Formulär  
  1. StudyEvent: ODM
    1. Study conclusion
Study conclusion
Beskrivning

Study conclusion

Date of last contact
Beskrivning

Date of last contact

Datatyp

date

Was the subject withdrawn from the study?
Beskrivning

Was the subject withdrawn from the study?

Datatyp

text

if "Yes" choose one primary reason for withdrawal:
Beskrivning

if "Yes" choose one primary reason for withdrawal:

Datatyp

text

Date of decision to withdraw
Beskrivning

Date of decision to withdraw

Datatyp

date

Investigator comment log
Beskrivning

Investigator comment log

Only use this form to record explanatory information on anomalies such as missing data, departures from planned investigational product administration or missed visits.
Beskrivning

Only use this form to record explanatory information on anomalies such as missing data, departures from planned investigational product administration or missed visits.

Datatyp

text

CRF page number
Beskrivning

if applicable

Datatyp

integer

Comment
Beskrivning

Comment

Datatyp

text

Investigator's signature
Beskrivning

Investigator's signature

Investigator's signature
Beskrivning

I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below

Datatyp

text

Investigator's name
Beskrivning

Print

Datatyp

text

Date
Beskrivning

Date

Datatyp

date

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Similar models

Study conclusion

1 Formulär
  1. StudyEvent: ODM
    1. Study conclusion
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Study conclusion
Date of last contact
Item
Date of last contact
date
Item
Was the subject withdrawn from the study?
text
Was the subject withdrawn from the study?
Code List
Was the subject withdrawn from the study?
CL Item
Yes (1)
CL Item
No (2)
Item
if "Yes" choose one primary reason for withdrawal:
text
if "Yes" choose one primary reason for withdrawal:
Code List
if "Yes" choose one primary reason for withdrawal:
CL Item
[1] Adverse event -> Record retails on the Non-Serious Adverse Events or Serious Adverse Events pages as appropriate (1)
CL Item
[3] Protocol deviation (2)
CL Item
[5] Study closed/terminated (3)
CL Item
[6] Lost to follow-up (4)
CL Item
[8] Withdrew consent (Only choose when none of the primary reasons are appropriate) (5)
Date of decision to withdraw
Item
Date of decision to withdraw
date
Item Group
Investigator comment log
Only use this form to record explanatory information on anomalies such as missing data, departures from planned investigational product administration or missed visits.
Item
Only use this form to record explanatory information on anomalies such as missing data, departures from planned investigational product administration or missed visits.
text
CRF page number
Item
CRF page number
integer
Comment
Item
Comment
text
Item Group
Investigator's signature
Investigator's signature
Item
Investigator's signature
text
Investigator's name
Item
Investigator's name
text
Date
Item
Date
date
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