ID

31977

Descripción

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

Palabras clave

Versiones (3)
  1. 9/10/18 9/10/18 -
  2. 10/10/18 10/10/18 -
  3. 21/11/18 21/11/18 -
Titular de derechos de autor

GSK group of companies

Subido en

10 de octubre de 2018

DOI

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Licencia

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

Inglés

Study conclusion

1 formularios  
  1. StudyEvent: ODM
    1. Study conclusion
Study conclusion
Descripción

Study conclusion

Date of last contact
Descripción

Date of last contact

Tipo de datos

date

Was the subject withdrawn from the study?
Descripción

Was the subject withdrawn from the study?

Tipo de datos

text

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

if "Yes" choose one primary reason for withdrawal:

Tipo de datos

text

Date of decision to withdraw
Descripción

Date of decision to withdraw

Tipo de datos

date

Investigator comment log
Descripción

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.
Descripción

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 datos

text

CRF page number
Descripción

if applicable

Tipo de datos

integer

Comment
Descripción

Comment

Tipo de datos

text

Investigator's signature
Descripción

Investigator's signature

Investigator's signature
Descripción

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 datos

text

Investigator's name
Descripción

Print

Tipo de datos

text

Date
Descripción

Date

Tipo de datos

date

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Study conclusion

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