ID

41973

Beschreibung

Study ID: 110159 Clinical Study ID: 110159 Study Title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00824356 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, GSK1004723 (200mg), GSK1004723 (1000mg) Study Indication: Allergic Rhinitis

Stichworte

Versionen (1)
  1. 02.03.21 02.03.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

2. März 2021

DOI

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Creative Commons BY 4.0
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Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356

Englisch

Follow-Up - Pregnancy Information; Status of Treatment Blind, Study Conclusion

1 Formulare  
Pregnancy Information
Beschreibung

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did a female partner of the male subject become pregnant during the study?
Beschreibung

If Yes, complete the paper Pregnancy Notification form.

Datentyp

text

Alias
UMLS CUI [1]
C0919624
Status of Treatment Blind
Beschreibung

Status of Treatment Blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind broken during the study?
Beschreibung

If yes, complete the Adverse Event form and/or Investigational Product forms as appropriate

Datentyp

boolean

Alias
UMLS CUI [1]
C3897431
If treatment blind was broken, record date/time blind broken
Beschreibung

If treatment blind was broken, record date/time blind broken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C1264639
Reason blind broken
Beschreibung

Reason blind broken

Datentyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Study Conclusion
Beschreibung

Study Conclusion

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

Date of subject completion or withdrawal

Datentyp

date

Alias
UMLS CUI [1]
C2983670
Was the subject withdrawn from the study?
Beschreibung

Was the subject withdrawn from the study?

Datentyp

text

Alias
UMLS CUI [1]
C0422727
Primary reason for withdrawal
Beschreibung

Primary reason for withdrawal

Datentyp

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Specify Investigator discretion
Beschreibung

Specify Investigator discretion

Datentyp

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0008961
UMLS CUI [1,3]
C0022423
Case book ready for signature
Beschreibung

Case book ready for signature

Datentyp

text

Alias
UMLS CUI [1,1]
C1706256
UMLS CUI [1,2]
C1519316
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Ähnliche Modelle

Follow-Up - Pregnancy Information; Status of Treatment Blind, Study Conclusion

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did a female partner of the male subject become pregnant during the study?
text
C0919624 (UMLS CUI [1])
Did a female partner of the male subject become pregnant during the study?
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Not Applicable (Check Not Applicable if female partner not of childbearing potential or no female partner (X)
Item Group
Status of Treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Was the treatment blind broken during the study?
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
If treatment blind was broken, record date/time blind broken
Item
If treatment blind was broken, record date/time blind broken
datetime
C3897431 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item
Reason blind broken
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason blind broken
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify (Z)
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])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Was the subject withdrawn from the study?
Code List
Was the subject withdrawn from the study?
CL Item
No (N)
CL Item
Yes, complete complete primary reason for withdrawal (Y)
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reason for withdrawal
Code List
Primary reason for withdrawal
CL Item
Adverse Event (Record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate) (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol deviation (3)
CL Item
Subject reached protocol defined stopping criteria (4)
CL Item
Study closed/terminated (5)
CL Item
Lost to Follow-up (6)
CL Item
Investigator discretion, specify (select this reason if none of the other primary reasons are appropriate) (7)
CL Item
Withdrew consent (8)
Specify Investigator discretion
Item
Specify Investigator discretion
text
C2348235 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
Item
Case book ready for signature
text
C1706256 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Case book ready for signature
Code List
Case book ready for signature
CL Item
Yes (Data owner should check thebox when data cleaning is complete) (Y)
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