ID

41781

Description

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

Mots-clés

Versions (1)
  1. 19/01/2021 19/01/2021 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

19 janvier 2021

DOI

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Licence

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

Anglais

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

1 Formulaires  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Type de données

text

Alias
UMLS CUI [1]
C2348585
Pregnancy Information
Description

Pregnancy Information

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

If Yes, complete Pregnancy Notification form.

Type de données

text

Alias
UMLS CUI [1]
C3828490
Study Conclusion
Description

Study Conclusion

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

Date of subject completion or withdrawal

Type de données

date

Alias
UMLS CUI [1]
C2983670
Time of withdrawal
Description

Time of withdrawal

Type de données

time

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Was the subject withdrawn from the study?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

Was the subject withdrawn from the study?

Type de données

boolean

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If subject was withdrawn from the study, check the primary reason for withdrawal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

If subject was withdrawn from the study, check the primary reason for withdrawal

Type de données

text

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

Specify other reason for withdrawal

Type de données

text

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

Investigator Comment Log

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

CRF page number if applicable

Type de données

integer

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

Comment

Type de données

text

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

Investigator's Signature

Alias
UMLS CUI-1
C2346576
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.

Type de données

text

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

Investigator's Signature - Date

Type de données

date

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

Investigator's name

Type de données

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 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

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