ID

38620

Description

Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Keywords

Versions (1)
  1. 10/28/19 10/28/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 28, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933

English

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

1 forms  
Date of Visit
Description

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of Visit/ Assessment
Description

Date of Visit/ Assessment

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Status of Treatment Blind
Description

Status of Treatment Blind

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

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

Data type

boolean

Alias
UMLS CUI [1]
C3897431
If treatment blind was broken during the study, enter date/ time blind broken.
Description

If treatment blind was broken during the study, enter date/ time blind broken.

Data type

datetime

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C3897431
UMLS CUI [2,2]
C0040223
Reason blind broken
Description

Reason blind broken

Data type

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
If other reason blind broken, please specify
Description

If other reason blind broken, please specify

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of last contact
Description

Date of last contact

Data type

date

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Was the subject withdrawn from the study?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

Was the subject withdrawn from the study?

Data type

boolean

Alias
UMLS CUI [1]
C0422727
If subject was withdrawn from study, please record date of decision to withdraw
Description

If subject was withdrawn from study, please record date of decision to withdraw

Data type

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0011008
Primary reason for withdrawal
Description

Primary reason for withdrawal

Data type

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
If investigator discretion, please specify
Description

If investigator discretion, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0022423
UMLS CUI [1,3]
C2348235
Pregnancy Information (Preg F)
Description

Pregnancy Information (Preg F)

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

Did the subject become pregnant during the study?

Data type

boolean

Alias
UMLS CUI [1]
C0032961
Pregnancy Information (Preg M)
Description

Pregnancy Information (Preg M)

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

Check Not applicable if female partner not of childbearing potential or no female partner.

Data type

text

Alias
UMLS CUI [1]
C0919624
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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
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 during the study, enter date/ time blind broken.
Item
If treatment blind was broken during the study, enter date/ time blind broken.
datetime
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C3897431 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Item
Reason blind broken
integer
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 (2)
If other reason blind broken, please specify
Item
If other reason blind broken, please specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
If subject was withdrawn from study, please record date of decision to withdraw
Item
If subject was withdrawn from study, please record date of decision to withdraw
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reasonfor withdrawal
Code List
Primary reason for withdrawal
CL Item
Adverse Event (Record details on the Non-Serious Adverse Events or Serious Adverse Events form 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)
If investigator discretion, please specify
Item
If investigator discretion, please specify
text
C0008961 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Pregnancy Information (Preg F)
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Did the subject become pregnant during the study?
Item
Did the subject become pregnant during the study?
boolean
C0032961 (UMLS CUI [1])
Item Group
Pregnancy Information (Preg M)
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 (X)
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