ID

41781

Descripción

Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

Palabras clave

Versiones (1)
  1. 19/1/21 19/1/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

19 de enero de 2021

DOI

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Licencia

Creative Commons BY 4.0
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Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096)

Inglés

End of Study - Pregnancy Information; Study Conclusion; Investigator Comment Log; Investigator's Signature

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Pregnancy Information
Descripción

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Descripción

If Yes, complete Pregnancy Notification form.

Tipo de datos

text

Alias
UMLS CUI [1]
C3828490
Study Conclusion
Descripción

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of subject completion or withdrawal
Descripción

Date of subject completion or withdrawal

Tipo de datos

date

Alias
UMLS CUI [1]
C2983670
Time of withdrawal
Descripción

Time of withdrawal

Tipo de datos

time

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0040223
Was the subject withdrawn from the study?
Descripción

Was the subject withdrawn from the study?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0422727
If subject was withdrawn from the study, check the primary reason for withdrawal
Descripción

If subject was withdrawn from the study, check the primary reason for withdrawal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3146298
Specify other reason for withdrawal
Descripción

Specify other reason for withdrawal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0205394
UMLS CUI [2]
C2348235
Investigator Comment Log
Descripción

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
CRF page number if applicable
Descripción

CRF page number if applicable

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1516308
Comment
Descripción

Comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Investigator's Signature
Descripción

Investigator's Signature

Alias
UMLS CUI-1
C2346576
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

Alias
UMLS CUI [1]
C2346576
Investigator's Signature - Date
Descripción

Investigator's Signature - Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator's name
Descripción

Investigator's name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
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Similar models

End of Study - Pregnancy Information; Study Conclusion; Investigator Comment Log; Investigator's Signature

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Did the subject become pregnant during the study?
Code List
Did the subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Applicable (not of childbearing potential or male) (X)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
Time of withdrawal
Item
Time of withdrawal
time
C2349954 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If subject was withdrawn from the study, check the primary reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
If subject was withdrawn from the study, check the primary reason for withdrawal
Code List
If subject was withdrawn from the study, check the primary reason for withdrawal
CL Item
Adverse events (Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate.) (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Sponsor terminated study (5)
CL Item
Non-compliance (17)
CL Item
Other, specify (Z)
Specify other reason for withdrawal
Item
Specify other reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
CRF page number if applicable
Item
CRF page number if applicable
integer
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's Signature - Date
Item
Investigator's Signature - Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's name
Item
Investigator's name
text
C2826892 (UMLS CUI [1])
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