ID

31977

Descrição

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

Palavras-chave

Versões (3)
  1. 09/10/2018 09/10/2018 -
  2. 10/10/2018 10/10/2018 -
  3. 21/11/2018 21/11/2018 -
Titular dos direitos

GSK group of companies

Transferido a

10 de outubro de 2018

DOI

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Licença

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

Inglês

Study conclusion

1 Formulários  
  1. StudyEvent: ODM
    1. Study conclusion
Study conclusion
Descrição

Study conclusion

Date of last contact
Descrição

Date of last contact

Tipo de dados

date

Was the subject withdrawn from the study?
Descrição

Was the subject withdrawn from the study?

Tipo de dados

text

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

if "Yes" choose one primary reason for withdrawal:

Tipo de dados

text

Date of decision to withdraw
Descrição

Date of decision to withdraw

Tipo de dados

date

Investigator comment log
Descrição

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.
Descrição

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

Tipo de dados

text

CRF page number
Descrição

if applicable

Tipo de dados

integer

Comment
Descrição

Comment

Tipo de dados

text

Investigator's signature
Descrição

Investigator's signature

Investigator's signature
Descrição

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

Tipo de dados

text

Investigator's name
Descrição

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Tipo de dados

text

Date
Descrição

Date

Tipo de dados

date

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Similar models

Study conclusion

1 Formulários
  1. StudyEvent: ODM
    1. Study conclusion
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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