ID

31977

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

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Versions (3)
  1. 10/9/18 10/9/18 -
  2. 10/10/18 10/10/18 -
  3. 11/21/18 11/21/18 -
Copyright Holder

GSK group of companies

Uploaded on

October 10, 2018

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Creative Commons BY-NC 3.0
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Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181

English

Study conclusion

1 forms  
  1. StudyEvent: ODM
    1. Study conclusion
Study conclusion
Description

Study conclusion

Date of last contact
Description

Date of last contact

Data type

date

Was the subject withdrawn from the study?
Description

Was the subject withdrawn from the study?

Data type

text

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

if "Yes" choose one primary reason for withdrawal:

Data type

text

Date of decision to withdraw
Description

Date of decision to withdraw

Data type

date

Investigator comment log
Description

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.
Description

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

Data type

text

CRF page number
Description

if applicable

Data type

integer

Comment
Description

Comment

Data type

text

Investigator's signature
Description

Investigator's signature

Investigator's signature
Description

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

Data type

text

Investigator's name
Description

Print

Data type

text

Date
Description

Date

Data type

date

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Study conclusion

1 forms
  1. StudyEvent: ODM
    1. Study conclusion
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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