ID

39761

Beschrijving

Study ID: 110852 Clinical Study ID: 110852 Study Title: MD7110852, A Phase 2b Dose-Ranging Study of Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01134055 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib eye drops, ranibizumab intravitreal injection, placebo Trade Name: pazopanib, ranibizumab Study Indication: Macular Degeneration

Trefwoorden

  1. 17-02-20 17-02-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

17 februari 2020

DOI

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Licentie

Creative Commons BY-NC 3.0

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Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration NCT01134055

Screen Failure

  1. StudyEvent: ODM
    1. Screen Failure
Date of Visit/ Assessment
Beschrijving

Date of Visit/ Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of Visit/ Assessment
Beschrijving

Date of Visit/ Assessment

Datatype

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Screen Failure
Beschrijving

Screen Failure

Alias
UMLS CUI-1
C1710476
Was this subject a screen failure?
Beschrijving

Was this subject a screen failure?

Datatype

boolean

Alias
UMLS CUI [1]
C1710476
Screen failure date
Beschrijving

Screen failure date

Datatype

date

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0011008
Reason for Screen Failure
Beschrijving

Reason for Screen Failure

Datatype

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
If reason for screen failure is investigator discretion, specify
Beschrijving

If reason for screen failure is investigator discretion, specify

Datatype

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
UMLS CUI [2,1]
C0008961
UMLS CUI [2,2]
C0022423
UMLS CUI [3]
C2348235
If reason for screen failure is withdrew consent, specify
Beschrijving

If reason for screen failure is withdrew consent, specify

Datatype

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
UMLS CUI [2]
C1707492
UMLS CUI [3]
C2348235
Investigator Signature
Beschrijving

Investigator Signature

Alias
UMLS CUI-1
C2346576
Is this casebook ready to sign?
Beschrijving

Is this casebook ready to sign?

Datatype

text

Alias
UMLS CUI [1]
C2346576
Tick or untick this box to require the investigator to re-sign the case book
Beschrijving

For Data Managers or Monitors only

Datatype

integer

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C1514873

Similar models

Screen Failure

  1. StudyEvent: ODM
    1. Screen Failure
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Date of Visit/ Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Screen Failure
C1710476 (UMLS CUI-1)
Was this subject a screen failure?
Item
Was this subject a screen failure?
boolean
C1710476 (UMLS CUI [1])
Screen failure date
Item
Screen failure date
date
C1710476 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason for Screen Failure
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Code List
Reason for Screen Failure
CL Item
Did not meet inclusion/exclusion criteria (F01)
CL Item
Adverse Event (F02)
CL Item
Lost to follow up (F07)
CL Item
Investigator discretion, specify (F08)
CL Item
Withdrew consent, specify (F09)
If reason for screen failure is investigator discretion, specify
Item
If reason for screen failure is investigator discretion, specify
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0008961 (UMLS CUI [2,1])
C0022423 (UMLS CUI [2,2])
C2348235 (UMLS CUI [3])
If reason for screen failure is withdrew consent, specify
Item
If reason for screen failure is withdrew consent, specify
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1707492 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item Group
Investigator Signature
C2346576 (UMLS CUI-1)
Item
Is this casebook ready to sign?
text
C2346576 (UMLS CUI [1])
Code List
Is this casebook ready to sign?
CL Item
Yes (Y)
Item
Tick or untick this box to require the investigator to re-sign the case book
integer
C2346576 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
Code List
Tick or untick this box to require the investigator to re-sign the case book
CL Item
Require the investigator to re-sign the case book (1)

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