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40120

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. 3/12/20 3/12/20 -
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GlaxoSmithKline

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March 12, 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

    Status of Treatment Mask; Investigational Product Discontinuation; Pregnancy Information; Investigational Product (Eye Drops) - Last Dose Date; Study Conclusion

    1 forms  
    Status of Treatment Mask
    Description

    Status of Treatment Mask

    Alias
    UMLS CUI-1
    C0749659 (Treatment Status)
    UMLS CUI-2
    C2347038 (Blinded Clinical Study)
    Was the treatment mask broken during the study?
    Description

    If yes, complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product forms as appropriate

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3897431 (Subject Unblinding Event Record)
    Date mask broken
    Description

    Date mask broken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3897431 (Subject Unblinding Event Record)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Reason mask broken
    Description

    Reason mask broken

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C3897431 (Subject Unblinding Event Record)
    UMLS CUI [1,2]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    If other reason for mask broken, specify
    Description

    If other reason for mask broken, specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3897431 (Subject Unblinding Event Record)
    UMLS CUI [1,2]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [2,1]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [2,2]
    C2348235 (Specification)
    Investigational Product Discontinuation
    Description

    Investigational Product Discontinuation

    Alias
    UMLS CUI-1
    C0304229 (Experimental drug)
    UMLS CUI-2
    C0457454 (Discontinuation (procedure))
    Was the investigational product stopped permanently before the scheduled end of the treatment period?
    Description

    Yes, complete primary reason

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C0457454 (Discontinuation (procedure))
    UMLS CUI [2,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [2,2]
    C1948053 (Period (temporal qualifier))
    SNOMED
    272117007
    UMLS CUI [2,3]
    C0205539 (Scheduled - procedure status)
    SNOMED
    416151008
    LOINC
    LA22866-0
    UMLS CUI [2,4]
    C0444930 (End)
    SNOMED
    261782000
    UMLS CUI [2,5]
    C0332152 (Before)
    SNOMED
    236874000
    Select primary reason the investigational product was stopped
    Description

    Select primary reason the investigational product was stopped

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,2]
    C0013230 (Investigational New Drugs)
    UMLS CUI [1,3]
    C0457454 (Discontinuation (procedure))
    If reason is Adverse Event, specify
    Description

    Record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. Check all that apply. If none, select "No Subreasons":

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255 (Serious Adverse Event)
    UMLS CUI [1,2]
    C2348235 (Specification)
    If Investigator discretion, specify
    Description

    Select this reason if none of the other primary reasons are appropriate.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008961 (Clinical Investigators)
    UMLS CUI [1,2]
    C0022423 (Judgment)
    SNOMED
    61254005
    UMLS CUI [1,3]
    C2348235 (Specification)
    If decision by subject or proxy, specify
    Description

    Select this reason if none of the other primary reasons are appropriate. Check all that apply. If none, select "No Subreasons":

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0679006 (Decision)
    UMLS CUI [1,2]
    C0681850 (Study Subject)
    UMLS CUI [1,3]
    C0600420 (Proxy)
    LOINC
    LP264346-0
    UMLS CUI [1,4]
    C2348235 (Specification)
    If other decision by subject or proxy, specify
    Description

    If other decision by subject or proxy, specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0679006 (Decision)
    UMLS CUI [1,2]
    C0681850 (Study Subject)
    UMLS CUI [1,3]
    C0600420 (Proxy)
    LOINC
    LP264346-0
    UMLS CUI [1,4]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,5]
    C2348235 (Specification)
    Pregnancy Information
    Description

    Pregnancy Information

    Alias
    UMLS CUI-1
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI-2
    C1533716 (Information)
    Did the subject become pregnant during the study?
    Description

    If Yes, complete the paper Pregnancy Notification form

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3828490 (Pregnant During the Study)
    Investigational Product (Eye Drops) - Last Dose Date
    Description

    Investigational Product (Eye Drops) - Last Dose Date

    Alias
    UMLS CUI-1
    C0304229 (Experimental drug)
    UMLS CUI-2
    C0015399 (Eye Drops)
    SNOMED
    385125006
    UMLS CUI-3
    C1762893 (Date last dose)
    LOINC
    LP29043-4
    Last Dose Date
    Description

    Last Dose Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1762893 (Date last dose)
    LOINC
    LP29043-4
    Study Conclusion
    Description

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478 (Conclusion)
    UMLS CUI-2
    C0008972 (Clinical Research)
    Date of subject completion or withdrawal
    Description

    Date of subject completion or withdrawal

    Data type

    date

    Alias
    UMLS CUI [1]
    C2983670 (Study End Date)
    Was the subject withdrawn from the study?
    Description

    Was the subject withdrawn from the study?

    Data type

    text

    Alias
    UMLS CUI [1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    Primary reason for withdrawal
    Description

    Primary reason for withdrawal

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,2]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    If reason for withdrawal is Adverse Event, specify
    Description

    Record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. Check all that apply. If none, select "No Subreasons":

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,3]
    C2349954 (Withdraw (activity))
    Investigator discretion, specify
    Description

    Select this reason if none of the other primary reasons are appropriate

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2348235 (Specification)
    UMLS CUI [1,2]
    C0008961 (Clinical Investigators)
    UMLS CUI [1,3]
    C0022423 (Judgment)
    SNOMED
    61254005
    Withdrew consent, specify
    Description

    Select this reason if none of the other primary reasons are appropriate. Check all that apply. If none, select "No Subreasons":

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1707492 (Consent Withdrawn)
    UMLS CUI [1,2]
    C2348235 (Specification)
    Back to the top of the page

    Similar models

    Status of Treatment Mask; Investigational Product Discontinuation; Pregnancy Information; Investigational Product (Eye Drops) - Last Dose Date; Study Conclusion

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Status of Treatment Mask
    C0749659 (UMLS CUI-1)
    C2347038 (UMLS CUI-2)
    Was the treatment mask broken during the study?
    Item
    Was the treatment mask broken during the study?
    boolean
    C3897431 (UMLS CUI [1])
    Date mask broken
    Item
    Date mask broken
    date
    C3897431 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Reason mask broken
    integer
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Reason mask broken
    Code List
    Reason mask broken
    CL Item
    Medical emergency requiring identification of investigational product for further treatment (1)
    CL Item
    Other, specify (2)
    If other reason for mask broken, specify
    Item
    If other reason for mask broken, specify
    text
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [2,1])
    C2348235 (UMLS CUI [2,2])
    Item Group
    Investigational Product Discontinuation
    C0304229 (UMLS CUI-1)
    C0457454 (UMLS CUI-2)
    Was the investigational product stopped permanently before the scheduled end of the treatment period?
    Item
    Was the investigational product stopped permanently before the scheduled end of the treatment period?
    boolean
    C0304229 (UMLS CUI [1,1])
    C0457454 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2,1])
    C1948053 (UMLS CUI [2,2])
    C0205539 (UMLS CUI [2,3])
    C0444930 (UMLS CUI [2,4])
    C0332152 (UMLS CUI [2,5])
    Item
    Select primary reason the investigational product was stopped
    text
    C0392360 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0457454 (UMLS CUI [1,3])
    Select primary reason the investigational product was stopped
    Code List
    Select primary reason the investigational product was stopped
    CL Item
    Other, specify (OT)
    CL Item
    Adverse Event, specify (1)
    CL Item
    Lack of efficacy (2)
    CL Item
    Protocol Deviation (3)
    CL Item
    Study closed/terminated (4)
    CL Item
    Lost to Follow-up (5)
    CL Item
    Investigator discretion, specify (6)
    CL Item
    Decision by subject or proxy (7)
    Item
    If reason is Adverse Event, specify
    text
    C1519255 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    If reason is Adverse Event, specify
    Code List
    If reason is Adverse Event, specify
    CL Item
    Exclusionary blood pressure (006)
    CL Item
    Subject met GSK defined liver chemistry stopping criteria (055)
    CL Item
    No subreasons (-99)
    If Investigator discretion, specify
    Item
    If Investigator discretion, specify
    text
    C0008961 (UMLS CUI [1,1])
    C0022423 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    If decision by subject or proxy, specify
    text
    C0679006 (UMLS CUI [1,1])
    C0681850 (UMLS CUI [1,2])
    C0600420 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    If decision by subject or proxy, specify
    Code List
    If decision by subject or proxy, specify
    CL Item
    Burden of procedures (39)
    CL Item
    Other, specify (OT)
    CL Item
    No subreasons (-99)
    If other decision by subject or proxy, specify
    Item
    If other decision by subject or proxy, specify
    text
    C0679006 (UMLS CUI [1,1])
    C0681850 (UMLS CUI [1,2])
    C0600420 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    C2348235 (UMLS CUI [1,5])
    Item Group
    Pregnancy Information
    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
    C3828490 (UMLS CUI [1])
    Item Group
    Investigational Product (Eye Drops) - Last Dose Date
    C0304229 (UMLS CUI-1)
    C0015399 (UMLS CUI-2)
    C1762893 (UMLS CUI-3)
    Last Dose Date
    Item
    Last Dose Date
    date
    C1762893 (UMLS CUI [1])
    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 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, specify (1)
    CL Item
    Lack of efficacy (2)
    CL Item
    Protocol Deviation (3)
    CL Item
    Study closed/terminated (5)
    CL Item
    Lost to Follow-up (6)
    CL Item
    Investigator discretion, specify  (7)
    CL Item
    Withdrew consent, specify (8)
    Item
    If reason for withdrawal is Adverse Event, specify
    text
    C0877248 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C2349954 (UMLS CUI [1,3])
    If reason for withdrawal is Adverse Event, specify
    Code List
    If reason for withdrawal is Adverse Event, specify
    CL Item
    Exclusionary blood pressure (006)
    CL Item
    Liver function test abnormality (017)
    CL Item
    No subreasons (-99)
    Investigator discretion, specify
    Item
    Investigator discretion, specify
    text
    C2348235 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    C0022423 (UMLS CUI [1,3])
    Item
    Withdrew consent, specify
    text
    C1707492 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Withdrew consent, specify
    Code List
    Withdrew consent, specify
    CL Item
    Burden of procedures (38)
    CL Item
    Other, specify (OT)
    CL Item
    No subreasons (-99)
    Back to the top of the page 

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