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39990

Description

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

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Versions (1)
  1. 3/8/20 3/8/20 -
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GlaxoSmithKline

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March 8, 2020

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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

    English

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

    1 forms  
    Administrative
    Description

    Administrative

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

    Date of visit/ assessment

    Data type

    date

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

    Early Withdrawal Visit

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

    Is this visit an early withdrawal visit?

    Data type

    boolean

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

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    First sitting BP reading
    Description

    First sitting BP reading

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

    Assessment Time

    Data type

    date

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

    Systolic blood pressure

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0871470
    mm[Hg]
    Diastolic blood pressure
    Description

    Diastolic blood pressure

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0428883
    mm[Hg]
    Second sitting BP reading
    Description

    Second sitting BP reading

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

    Systolic blood pressure

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0871470
    mm[Hg]
    Diastolic blood pressure
    Description

    Diastolic blood pressure

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0428883
    mm[Hg]
    Electronically Transferred Lab Data
    Description

    Electronically Transferred Lab Data

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

    Date sample taken

    Data type

    date

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

    Sample taken - not done

    Data type

    integer

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

    Haem Lab type code

    Data type

    text

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

    Chem Lab type code

    Data type

    text

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

    Urin Lab type code

    Data type

    text

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

    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?
    Description

    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.

    Data type

    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
    Description

    Specify type of liver chemistry event

    Data type

    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 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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