ID

39990

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2020-03-08 2020-03-08 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

8 mars 2020

DOI

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Creative Commons BY-NC 4.0
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Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration NCT01134055

Engelsk

Week 52 - Early Withdrawal Visit; Vital Signs; Electronically Transferred Lab Data; Liver event assessment

1 Formulär  
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Date of visit/ assessment
Beskrivning

Date of visit/ assessment

Datatyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Early Withdrawal Visit
Beskrivning

Early Withdrawal Visit

Alias
UMLS CUI-1
C1279919
UMLS CUI-2
C2349954
UMLS CUI-3
C0545082
Is this visit an early withdrawal visit?
Beskrivning

Is this visit an early withdrawal visit?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1279919
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0545082
Vital Signs
Beskrivning

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
First sitting BP reading
Beskrivning

First sitting BP reading

Alias
UMLS CUI-1
C0005823
UMLS CUI-2
C0277814
UMLS CUI-3
C0205435
Assessment Time
Beskrivning

Assessment Time

Datatyp

date

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0040223
Systolic blood pressure
Beskrivning

Systolic blood pressure

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic blood pressure
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Second sitting BP reading
Beskrivning

Second sitting BP reading

Alias
UMLS CUI-1
C0005823
UMLS CUI-2
C0277814
UMLS CUI-3
C0205436
Systolic blood pressure
Beskrivning

Systolic blood pressure

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic blood pressure
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Electronically Transferred Lab Data
Beskrivning

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0745590
UMLS CUI-2
C1705822
Date sample taken
Beskrivning

Date sample taken

Datatyp

date

Alias
UMLS CUI [1]
C1302413
Sample taken - not done
Beskrivning

Sample taken - not done

Datatyp

integer

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C1272696
Haem Lab type code
Beskrivning

Haem Lab type code

Datatyp

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0805701
Chem Lab type code
Beskrivning

Chem Lab type code

Datatyp

text

Alias
UMLS CUI [1,1]
C0005774
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0805701
Urin Lab type code
Beskrivning

Urin Lab type code

Datatyp

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0022877
Liver event assessment
Beskrivning

Liver event assessment

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0220825
Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
Beskrivning

Note: If a subject has been monitored for 4 weeks and continues to meet liver chemistry monitoring criteria, subject must be identified as a liver event. If Yes and type of liver chemistry event is Liver Monitoring, obtain tests as per protocol.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C0005834
UMLS CUI [1,5]
C0545082
Specify type of liver chemistry event
Beskrivning

Specify type of liver chemistry event

Datatyp

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C2348235
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Similar models

Week 52 - Early Withdrawal Visit; Vital Signs; Electronically Transferred Lab Data; Liver event assessment

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative
C1320722 (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
Early Withdrawal Visit
C1279919 (UMLS CUI-1)
C2349954 (UMLS CUI-2)
C0545082 (UMLS CUI-3)
Is this visit an early withdrawal visit?
Item
Is this visit an early withdrawal visit?
boolean
C1279919 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
First sitting BP reading
C0005823 (UMLS CUI-1)
C0277814 (UMLS CUI-2)
C0205435 (UMLS CUI-3)
Assessment Time
Item
Assessment Time
date
C1516048 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Item Group
Second sitting BP reading
C0005823 (UMLS CUI-1)
C0277814 (UMLS CUI-2)
C0205436 (UMLS CUI-3)
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Item Group
Electronically Transferred Lab Data
C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
Sample taken - not done
integer
C0200345 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Sample taken - not done
Code List
Sample taken - not done
CL Item
Not done (1)
Haem Lab type code
Item
Haem Lab type code
text
C0018941 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Chem Lab type code
Item
Chem Lab type code
text
C0005774 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Urin Lab type code
Item
Urin Lab type code
text
C0042014 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Item Group
Liver event assessment
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
Item
Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
boolean
C0008000 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
Item
Specify type of liver chemistry event
integer
C0008000 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Specify type of liver chemistry event
Code List
Specify type of liver chemistry event
CL Item
Liver Event Monitoring Criteria (subject has met protocol defined liver event monitoring criteria) (1)
CL Item
Liver Event Stopping Criteria (subject has met protocol defined liver event stopping criteria or has been monitored for 4 weeks and continues to meet liver chemistry event criteria) (3)
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