ID

32941

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

Keywords

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

GlaxoSmithKline

Uploaded on

November 21, 2018

DOI

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License

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 last contact

Data type

date

Alias
UMLS CUI [1]
C0805839
Was the subject withdrawn from the study?
Description

Patient withdrawn from trial

Data type

boolean

Alias
UMLS CUI [1]
C0422727
if "Yes" choose one primary reason for withdrawal:
Description

Patient withdrawn from trial, Indication

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3146298
Date of decision to withdraw
Description

Patient withdrawn from trial, Decision, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0011008
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Similar models

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 last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Patient withdrawn from trial
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
if "Yes" choose one primary reason for withdrawal:
text
C0422727 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
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)
Patient withdrawn from trial, Decision, Date in time
Item
Date of decision to withdraw
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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