0 Evaluaciones
ID

39762

Descripción

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

Palabras clave

Versiones (1)
  1. 17/2/20 17/2/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

17 de febrero de 2020

DOI

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Licencia

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

    Inglés

    Unscheduled - Vital Signs; Electronically Transferred Lab Data; Liver event assessment; ETDRS Refraction; ETDRS Visual Acuity; Intraocular Pressure Exam; External Ocular Exam; Eye Lid and Lash Exam

    1 formularios  
    Administrative
    Descripción

    Administrative

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

    Date of visit/ assessment

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C2985720
    Vital Signs
    Descripción

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Heart rate
    Descripción

    Heart rate

    Tipo de datos

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    First sitting BP reading
    Descripción

    First sitting BP reading

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

    Assessment Time

    Tipo de datos

    date

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

    Systolic blood pressure

    Tipo de datos

    integer

    Unidades de medida
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0871470
    mm[Hg]
    Diastolic blood pressure
    Descripción

    Diastolic blood pressure

    Tipo de datos

    integer

    Unidades de medida
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0428883
    mm[Hg]
    Second sitting BP reading
    Descripción

    Second sitting BP reading

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

    Systolic blood pressure

    Tipo de datos

    integer

    Unidades de medida
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0871470
    mm[Hg]
    Diastolic blood pressure
    Descripción

    Diastolic blood pressure

    Tipo de datos

    integer

    Unidades de medida
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0428883
    mm[Hg]
    Electronically Transferred Lab Data
    Descripción

    Electronically Transferred Lab Data

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

    Date sample taken

    Tipo de datos

    date

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

    Sample taken - not done

    Tipo de datos

    integer

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

    Haem Lab type code

    Tipo de datos

    text

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

    Chem Lab type code

    Tipo de datos

    text

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

    Urin Lab type code

    Tipo de datos

    text

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

    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?
    Descripción

    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.

    Tipo de datos

    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
    Descripción

    Specify type of liver chemistry event

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0023884
    UMLS CUI [1,3]
    C0877248
    UMLS CUI [1,4]
    C2348235
    ETDRS Refraction
    Descripción

    ETDRS Refraction

    Alias
    UMLS CUI-1
    C3899277
    UMLS CUI-2
    C0034949
    Assessment date
    Descripción

    Assessment date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2985720
    Sphere - Right Eye
    Descripción

    Sphere - Right Eye

    Tipo de datos

    float

    Alias
    UMLS CUI [1,1]
    C0946401
    UMLS CUI [1,2]
    C0229089
    Cylinder - Right Eye
    Descripción

    Cylinder - Right Eye

    Tipo de datos

    float

    Alias
    UMLS CUI [1,1]
    C0946265
    UMLS CUI [1,2]
    C0229089
    Axis - Right Eye
    Descripción

    Axis - Right Eye

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0429590
    UMLS CUI [1,2]
    C0229089
    Sphere - Left Eye
    Descripción

    Sphere - Left Eye

    Tipo de datos

    float

    Alias
    UMLS CUI [1,1]
    C0946401
    UMLS CUI [1,2]
    C0229090
    Cylinder - Left Eye
    Descripción

    Cylinder - Left Eye

    Tipo de datos

    float

    Alias
    UMLS CUI [1,1]
    C0946265
    UMLS CUI [1,2]
    C0229090
    Axis - Left Eye
    Descripción

    Axis - Left Eye

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0429590
    UMLS CUI [1,2]
    C0229090
    ETDRS Visual Acuity
    Descripción

    ETDRS Visual Acuity

    Alias
    UMLS CUI-1
    C1275992
    Assessment Date and Time
    Descripción

    Assessment Date and Time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C2985720
    UMLS CUI [1,2]
    C1264639
    Assessor's Certification Number
    Descripción

    Assessor's Certification Number

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0007836
    UMLS CUI [1,2]
    C0600091
    UMLS CUI [1,3]
    C2646699
    Total calculated visual acuity score - Right Eye
    Descripción

    Total calculated visual acuity score - Right Eye

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1275992
    UMLS CUI [1,2]
    C0229089
    UMLS CUI [1,3]
    C0444686
    Has there been a visual acuity loss that is more than 15 letters since the previous visit? - Right Eye
    Descripción

    If yes, select the predominant cause

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0234632
    UMLS CUI [2,1]
    C0545082
    UMLS CUI [2,2]
    C1517741
    UMLS CUI [2,3]
    C1711239
    UMLS CUI [3]
    C0229089
    Predominant cause of visual acuity loss - Right Eye
    Descripción

    Predominant cause of visual acuity loss - Right Eye

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0234632
    UMLS CUI [1,2]
    C0015127
    UMLS CUI [2]
    C0229089
    Snellen/Acuity Equivalent - Right Eye
    Descripción

    Snellen/Acuity Equivalent - Right Eye

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1827708
    UMLS CUI [1,2]
    C0229089
    If performed at 4 Meters, specify
    Descripción

    If performed at 4 Meters, specify

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    If performed at 1 Meter, specify
    Descripción

    If performed at 1 Meter, specify

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    Light Perception - Right Eye
    Descripción

    Light Perception - Right Eye

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1154616
    UMLS CUI [1,2]
    C0229089
    Total calculated visual acuity score - Left Eye
    Descripción

    Total calculated visual acuity score - Left Eye

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1275992
    UMLS CUI [1,2]
    C0229090
    UMLS CUI [1,3]
    C0444686
    Has there been a visual acuity loss that is more than 15 letters since the previous visit? - Left Eye
    Descripción

    If yes, select the predominant cause

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0234632
    UMLS CUI [2,1]
    C0545082
    UMLS CUI [2,2]
    C1517741
    UMLS CUI [2,3]
    C1711239
    UMLS CUI [3]
    C0229090
    Predominant cause of visual acuity loss - Left Eye
    Descripción

    Predominant cause of visual acuity loss - Left Eye

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0234632
    UMLS CUI [1,2]
    C0015127
    UMLS CUI [2]
    C0229090
    Snellen/Acuity Equivalent - Left Eye
    Descripción

    Snellen/Acuity Equivalent - Left Eye

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1827708
    UMLS CUI [1,2]
    C0229090
    If performed at 4 Meters, specify
    Descripción

    If performed at 4 Meters, specify

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229090
    If performed at 1 Meter, specify
    Descripción

    If performed at 1 Meter, specify

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229090
    Light Perception - Left Eye
    Descripción

    Light Perception - Left Eye

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1154616
    UMLS CUI [1,2]
    C0229090
    Intraocular Pressure Exam
    Descripción

    Intraocular Pressure Exam

    Alias
    UMLS CUI-1
    C0430888
    Intraocular Pressure Exam - Assessment Date and Time
    Descripción

    Intraocular Pressure Exam - Assessment Date and Time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0430888
    UMLS CUI [1,2]
    C2985720
    UMLS CUI [1,3]
    C1264639
    Intraocular Pressure Measurement - Right Eye
    Descripción

    Intraocular Pressure Measurement - Right Eye

    Tipo de datos

    integer

    Unidades de medida
    • mm[Hg]
    Alias
    UMLS CUI [1,1]
    C0040420
    UMLS CUI [1,2]
    C0229089
    mm[Hg]
    Intraocular Pressure Measurement - Left Eye
    Descripción

    Intraocular Pressure Measurement - Left Eye

    Tipo de datos

    integer

    Unidades de medida
    • mm[Hg]
    Alias
    UMLS CUI [1,1]
    C0040420
    UMLS CUI [1,2]
    C0229090
    mm[Hg]
    External Ocular Exam
    Descripción

    External Ocular Exam

    Alias
    UMLS CUI-1
    C0031809
    UMLS CUI-2
    C1299003
    External Ocular Exam - Assessment date
    Descripción

    External Ocular Exam - Assessment date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C1299003
    UMLS CUI [1,3]
    C2985720
    Pupil Exam - Right Eye
    Descripción

    Pupil Exam - Right Eye

    Alias
    UMLS CUI-1
    C0031809
    UMLS CUI-2
    C0034121
    UMLS CUI-3
    C0229089
    Pupils are equal, round, and reactive to light (PERRL)
    Descripción

    Pupils are equal, round, and reactive to light (PERRL)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0034121
    UMLS CUI [1,2]
    C0205163
    UMLS CUI [2,1]
    C0034121
    UMLS CUI [2,2]
    C0332490
    UMLS CUI [3,1]
    C0034121
    UMLS CUI [3,2]
    C0205332
    If other pupil finding, specify
    Descripción

    If other pupil finding, specify

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0034121
    UMLS CUI [1,2]
    C0243095
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    Afferent pupillary defect (APD) - Right Eye
    Descripción

    Afferent pupillary defect (APD) - Right Eye

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0339662
    UMLS CUI [1,2]
    C0229089
    Pupil Exam - Left Eye
    Descripción

    Pupil Exam - Left Eye

    Alias
    UMLS CUI-1
    C0031809
    UMLS CUI-2
    C0034121
    UMLS CUI-3
    C0229090
    Pupils are equal, round, and reactive to light (PERRL)
    Descripción

    Pupils are equal, round, and reactive to light (PERRL)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0034121
    UMLS CUI [1,2]
    C0205163
    UMLS CUI [2,1]
    C0034121
    UMLS CUI [2,2]
    C0332490
    UMLS CUI [3,1]
    C0034121
    UMLS CUI [3,2]
    C0205332
    If other pupil finding, specify
    Descripción

    If other pupil finding, specify

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0034121
    UMLS CUI [1,2]
    C0243095
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    Afferent pupillary defect (APD) - Left Eye
    Descripción

    Afferent pupillary defect (APD) - Left Eye

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0339662
    UMLS CUI [1,2]
    C0229090
    Motility Exam
    Descripción

    Motility Exam

    Alias
    UMLS CUI-1
    C1510470
    Motility Exam - Right Eye
    Descripción

    Motility Exam - Right Eye

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1510470
    UMLS CUI [1,2]
    C0229089
    Motility Exam - Left Eye
    Descripción

    Motility Exam - Left Eye

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1510470
    UMLS CUI [1,2]
    C0229089
    Confrontation Visual Field
    Descripción

    Confrontation Visual Field

    Alias
    UMLS CUI-1
    C1444674
    Eye full to confrontation - Right Eye
    Descripción

    Eye full to confrontation - Right Eye

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2053834
    If other Confrontation Visual Field, specify - Right Eye
    Descripción

    If other Confrontation Visual Field, specify - Right Eye

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1444674
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    UMLS CUI [1,4]
    C0229089
    Eye full to confrontation - Left Eye
    Descripción

    Eye full to confrontation - Left Eye

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2053833
    If other Confrontation Visual Field, specify - Left Eye
    Descripción

    If other Confrontation Visual Field, specify - Left Eye

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1444674
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    UMLS CUI [1,4]
    C0229090
    Eye Lid and Lash Exam
    Descripción

    Eye Lid and Lash Exam

    Alias
    UMLS CUI-1
    C0031809
    UMLS CUI-2
    C0015392
    UMLS CUI-3
    C2706046
    Eye Lid and Lash Exam - Assessment date
    Descripción

    Eye Lid and Lash Exam - Assessment date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0015392
    UMLS CUI [1,3]
    C2706046
    UMLS CUI [2]
    C2985720
    Right Upper Eye Lid
    Descripción

    Right Upper Eye Lid

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0229089
    UMLS CUI [1,2]
    C0585636
    If other finding of right upper eye lid, sepcify
    Descripción

    If other finding of right upper eye lid, sepcify

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0229089
    UMLS CUI [1,2]
    C0585636
    UMLS CUI [2,1]
    C0243095
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [2,3]
    C2348235
    Right Lower Eye Lid
    Descripción

    Right Lower Eye Lid

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0229089
    UMLS CUI [1,2]
    C2706046
    UMLS CUI [1,3]
    C0205251
    If other finding of right lower eye lid, specify
    Descripción

    If other finding of right lower eye lid, specify

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0229089
    UMLS CUI [1,2]
    C2706046
    UMLS CUI [1,3]
    C0205251
    UMLS CUI [2,1]
    C0243095
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [2,3]
    C2348235
    Meibomian Gland Dysfunction Right Eye
    Descripción

    Meibomian Gland Dysfunction Right Eye

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1275684
    UMLS CUI [1,2]
    C0229089
    Right Eye Eyelid margin
    Descripción

    Right Eye Eyelid margin

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0444582
    UMLS CUI [1,2]
    C0229089
    If other finding of eyelid margin of right eye, specify
    Descripción

    If other finding of eyelid margin of right eye, specify

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0444582
    UMLS CUI [1,2]
    C0229089
    UMLS CUI [2,1]
    C0243095
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [2,3]
    C2348235
    Left Upper Eye Lid
    Descripción

    Left Upper Eye Lid

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0229090
    UMLS CUI [1,2]
    C0585636
    If other finding of left upper eye lid, sepcify
    Descripción

    If other finding of left upper eye lid, sepcify

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0229090
    UMLS CUI [1,2]
    C0585636
    UMLS CUI [2,1]
    C0243095
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [2,3]
    C2348235
    Left Lower Eye Lid
    Descripción

    Left Lower Eye Lid

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0229090
    UMLS CUI [1,2]
    C2706046
    UMLS CUI [1,3]
    C0205251
    If other finding of left lower eye lid, specify
    Descripción

    If other finding of left lower eye lid, specify

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0229090
    UMLS CUI [1,2]
    C2706046
    UMLS CUI [1,3]
    C0205251
    UMLS CUI [2,1]
    C0243095
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [2,3]
    C2348235
    Meibomian Gland Dysfunction Left Eye
    Descripción

    Meibomian Gland Dysfunction Left Eye

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1275684
    UMLS CUI [1,2]
    C0229090
    Left Eye Eyelid margin
    Descripción

    Left Eye Eyelid margin

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0444582
    UMLS CUI [1,2]
    C0229090
    If other finding of eyelid margin of left eye, specify
    Descripción

    If other finding of eyelid margin of left eye, specify

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0444582
    UMLS CUI [1,2]
    C0229090
    UMLS CUI [2,1]
    C0243095
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [2,3]
    C2348235
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    Similar models

    Unscheduled - Vital Signs; Electronically Transferred Lab Data; Liver event assessment; ETDRS Refraction; ETDRS Visual Acuity; Intraocular Pressure Exam; External Ocular Exam; Eye Lid and Lash Exam

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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
    Vital Signs
    C0518766 (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)
    Item Group
    ETDRS Refraction
    C3899277 (UMLS CUI-1)
    C0034949 (UMLS CUI-2)
    Assessment date
    Item
    Assessment date
    date
    C2985720 (UMLS CUI [1])
    Sphere - Right Eye
    Item
    Sphere - Right Eye
    float
    C0946401 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    Cylinder - Right Eye
    Item
    Cylinder - Right Eye
    float
    C0946265 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    Axis - Right Eye
    Item
    Axis - Right Eye
    integer
    C0429590 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    Sphere - Left Eye
    Item
    Sphere - Left Eye
    float
    C0946401 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    Cylinder - Left Eye
    Item
    Cylinder - Left Eye
    float
    C0946265 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    Axis - Left Eye
    Item
    Axis - Left Eye
    integer
    C0429590 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    Item Group
    ETDRS Visual Acuity
    C1275992 (UMLS CUI-1)
    Assessment Date and Time
    Item
    Assessment Date and Time
    datetime
    C2985720 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    Assessor's Certification Number
    Item
    Assessor's Certification Number
    text
    C0007836 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    C2646699 (UMLS CUI [1,3])
    Total calculated visual acuity score - Right Eye
    Item
    Total calculated visual acuity score - Right Eye
    integer
    C1275992 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    C0444686 (UMLS CUI [1,3])
    Has there been a visual acuity loss that is more than 15 letters since the previous visit? - Right Eye
    Item
    Has there been a visual acuity loss that is more than 15 letters since the previous visit? - Right Eye
    boolean
    C0234632 (UMLS CUI [1])
    C0545082 (UMLS CUI [2,1])
    C1517741 (UMLS CUI [2,2])
    C1711239 (UMLS CUI [2,3])
    C0229089 (UMLS CUI [3])
    Item
    Predominant cause of visual acuity loss - Right Eye
    text
    C0234632 (UMLS CUI [1,1])
    C0015127 (UMLS CUI [1,2])
    C0229089 (UMLS CUI [2])
    Predominant cause of visual acuity loss
    Code List
    Predominant cause of visual acuity loss - Right Eye
    CL Item
    Hemorrhage (1)
    CL Item
    Fluid/edema (2)
    CL Item
    Unknown (3)
    CL Item
    Other, specify A100 (OT)
    Item
    Snellen/Acuity Equivalent - Right Eye
    integer
    C1827708 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    Snellen/Acuity Equivalent - Right Eye
    Code List
    Snellen/Acuity Equivalent - Right Eye
    CL Item
    Performed at 4 Meters (4)
    CL Item
    Performed at 1 Meter (1)
    Item
    If performed at 4 Meters, specify
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    If performed at 4 Meters, specify
    Code List
    If performed at 4 Meters, specify
    CL Item
    20/200 (0401)
    CL Item
    20/160 (0402)
    CL Item
    20/125 (0403)
    CL Item
    20/100 (0404)
    CL Item
    20/80 (0405)
    CL Item
    20/63 (0406)
    CL Item
    20/50 (0407)
    CL Item
    20/40 (0408)
    CL Item
    20/32 (0409)
    CL Item
    20/25 (0410)
    CL Item
    20/20 (0411)
    CL Item
    20/16 (0412)
    CL Item
    20/12.5 (0415)
    CL Item
    20/10 (0414)
    Item
    If performed at 1 Meter, specify
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    If performed at 1 Meter, specify
    Code List
    If performed at 1 Meter, specify
    CL Item
    20/800 (0101)
    CL Item
    20/640 (0102)
    CL Item
    20/500 (0103)
    CL Item
    20/400 (0104)
    CL Item
    20/320 (0105)
    CL Item
    20/350 (0106)
    Item
    Light Perception - Right Eye
    integer
    C1154616 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    Light Perception - Right Eye
    Code List
    Light Perception - Right Eye
    CL Item
    Not applicable (4)
    CL Item
    No light perception (0)
    CL Item
    Light perception (1)
    CL Item
    Perceives hand motions (2)
    CL Item
    Counts fingers (3)
    Total calculated visual acuity score - Left Eye
    Item
    Total calculated visual acuity score - Left Eye
    integer
    C1275992 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    C0444686 (UMLS CUI [1,3])
    Has there been a visual acuity loss that is more than 15 letters since the previous visit? - Left Eye
    Item
    Has there been a visual acuity loss that is more than 15 letters since the previous visit? - Left Eye
    boolean
    C0234632 (UMLS CUI [1])
    C0545082 (UMLS CUI [2,1])
    C1517741 (UMLS CUI [2,2])
    C1711239 (UMLS CUI [2,3])
    C0229090 (UMLS CUI [3])
    Item
    Predominant cause of visual acuity loss - Left Eye
    text
    C0234632 (UMLS CUI [1,1])
    C0015127 (UMLS CUI [1,2])
    C0229090 (UMLS CUI [2])
    Predominant cause of visual acuity loss - Left Eye
    Code List
    Predominant cause of visual acuity loss - Left Eye
    CL Item
    Hemorrhage (1)
    CL Item
    Fluid/edema (2)
    CL Item
    Unknown (3)
    CL Item
    Other, specify A100 (OT)
    Item
    Snellen/Acuity Equivalent - Left Eye
    integer
    C1827708 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    Snellen/Acuity Equivalent - Left Eye
    Code List
    Snellen/Acuity Equivalent - Left Eye
    CL Item
    Performed at 4 Meters  (4)
    CL Item
    Performed at 1 Meter (1)
    Item
    If performed at 4 Meters, specify
    integer
    C0442746 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    If performed at 4 Meters, specify
    Code List
    If performed at 4 Meters, specify
    CL Item
    20/200 (0401)
    CL Item
    20/160 (0402)
    CL Item
    20/125 (0403)
    CL Item
    20/100 (0404)
    CL Item
    20/80 (0405)
    CL Item
    20/63 (0406)
    CL Item
    20/50 (0407)
    CL Item
    20/40 (0408)
    CL Item
    20/32 (0409)
    CL Item
    20/25 (0410)
    CL Item
    20/20 (0411)
    CL Item
    20/16 (0412)
    CL Item
    20/12.5 (0415)
    CL Item
    20/10 (0414)
    Item
    If performed at 1 Meter, specify
    integer
    C0442746 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    If performed at 1 Meter, specify
    Code List
    If performed at 1 Meter, specify
    CL Item
    20/800 (0101)
    CL Item
    20/640 (0102)
    CL Item
    20/500 (0103)
    CL Item
    20/400 (0104)
    CL Item
    20/320 (0105)
    CL Item
    20/350 (0106)
    Item
    Light Perception - Left Eye
    integer
    C1154616 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    Light Perception - Left Eye
    Code List
    Light Perception - Left Eye
    CL Item
    Not applicable  (4)
    CL Item
    No light perception  (0)
    CL Item
    Light perception  (1)
    CL Item
    Perceives hand motions  (2)
    CL Item
    Counts fingers (3)
    Item Group
    Intraocular Pressure Exam
    C0430888 (UMLS CUI-1)
    Intraocular Pressure Exam - Assessment Date and Time
    Item
    Intraocular Pressure Exam - Assessment Date and Time
    datetime
    C0430888 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    C1264639 (UMLS CUI [1,3])
    Intraocular Pressure Measurement - Right Eye
    Item
    Intraocular Pressure Measurement - Right Eye
    integer
    C0040420 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    Intraocular Pressure Measurement - Left Eye
    Item
    Intraocular Pressure Measurement - Left Eye
    integer
    C0040420 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    Item Group
    External Ocular Exam
    C0031809 (UMLS CUI-1)
    C1299003 (UMLS CUI-2)
    External Ocular Exam - Assessment date
    Item
    External Ocular Exam - Assessment date
    date
    C0031809 (UMLS CUI [1,1])
    C1299003 (UMLS CUI [1,2])
    C2985720 (UMLS CUI [1,3])
    Item Group
    Pupil Exam - Right Eye
    C0031809 (UMLS CUI-1)
    C0034121 (UMLS CUI-2)
    C0229089 (UMLS CUI-3)
    Item
    Pupils are equal, round, and reactive to light (PERRL)
    text
    C0034121 (UMLS CUI [1,1])
    C0205163 (UMLS CUI [1,2])
    C0034121 (UMLS CUI [2,1])
    C0332490 (UMLS CUI [2,2])
    C0034121 (UMLS CUI [3,1])
    C0205332 (UMLS CUI [3,2])
    Pupils are equal, round, and reactive to light (PERRL)
    Code List
    Pupils are equal, round, and reactive to light (PERRL)
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    CL Item
    Post-surgical  (PERRLPSU)
    CL Item
    Other, Specify (?)
    If other pupil finding, specify
    Item
    If other pupil finding, specify
    text
    C0034121 (UMLS CUI [1,1])
    C0243095 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Item
    Afferent pupillary defect (APD) - Right Eye
    integer
    C0339662 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    Afferent pupillary defect (APD) - Right Eye
    Code List
    Afferent pupillary defect (APD) - Right Eye
    CL Item
    Present  (1)
    CL Item
    Absent (2)
    Item Group
    Pupil Exam - Left Eye
    C0031809 (UMLS CUI-1)
    C0034121 (UMLS CUI-2)
    C0229090 (UMLS CUI-3)
    Item
    Pupils are equal, round, and reactive to light (PERRL)
    text
    C0034121 (UMLS CUI [1,1])
    C0205163 (UMLS CUI [1,2])
    C0034121 (UMLS CUI [2,1])
    C0332490 (UMLS CUI [2,2])
    C0034121 (UMLS CUI [3,1])
    C0205332 (UMLS CUI [3,2])
    Pupils are equal, round, and reactive to light (PERRL)
    Code List
    Pupils are equal, round, and reactive to light (PERRL)
    CL Item
    Normal  (1)
    CL Item
    Abnormal PERRLPSU=Post-surgical  (2)
    CL Item
    Other, Specify (?)
    If other pupil finding, specify
    Item
    If other pupil finding, specify
    text
    C0034121 (UMLS CUI [1,1])
    C0243095 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Item
    Afferent pupillary defect (APD) - Left Eye
    integer
    C0339662 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    Afferent pupillary defect (APD) - Left Eye
    Code List
    Afferent pupillary defect (APD) - Left Eye
    CL Item
    Present  (1)
    CL Item
    Absent (2)
    Item Group
    Motility Exam
    C1510470 (UMLS CUI-1)
    Item
    Motility Exam - Right Eye
    integer
    C1510470 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    Motility Exam - Right Eye
    Code List
    Motility Exam - Right Eye
    CL Item
    Normal  (1)
    CL Item
    Abnormal, Specify (2)
    Item
    Motility Exam - Left Eye
    integer
    C1510470 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    Motility Exam - Left Eye
    Code List
    Motility Exam - Left Eye
    CL Item
    Normal  (1)
    CL Item
    Abnormal, Specify (2)
    Item Group
    Confrontation Visual Field
    C1444674 (UMLS CUI-1)
    Item
    Eye full to confrontation - Right Eye
    integer
    C2053834 (UMLS CUI [1])
    Eye full to confrontation - Right Eye
    Code List
    Eye full to confrontation - Right Eye
    CL Item
    Normal  (1)
    CL Item
    Abnormal, specify (2)
    If other Confrontation Visual Field, specify - Right Eye
    Item
    If other Confrontation Visual Field, specify - Right Eye
    text
    C1444674 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    C0229089 (UMLS CUI [1,4])
    Item
    Eye full to confrontation - Left Eye
    integer
    C2053833 (UMLS CUI [1])
    Eye full to confrontation - Left Eye
    Code List
    Eye full to confrontation - Left Eye
    CL Item
    Normal  (1)
    CL Item
    Abnormal, specify (2)
    If other Confrontation Visual Field, specify - Left Eye
    Item
    If other Confrontation Visual Field, specify - Left Eye
    text
    C1444674 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    C0229090 (UMLS CUI [1,4])
    Item Group
    Eye Lid and Lash Exam
    C0031809 (UMLS CUI-1)
    C0015392 (UMLS CUI-2)
    C2706046 (UMLS CUI-3)
    Eye Lid and Lash Exam - Assessment date
    Item
    Eye Lid and Lash Exam - Assessment date
    date
    C0031809 (UMLS CUI [1,1])
    C0015392 (UMLS CUI [1,2])
    C2706046 (UMLS CUI [1,3])
    C2985720 (UMLS CUI [2])
    Item
    Right Upper Eye Lid
    text
    C0229089 (UMLS CUI [1,1])
    C0585636 (UMLS CUI [1,2])
    Right Upper Eye Lid
    Code List
    Right Upper Eye Lid
    CL Item
    Normal  (1)
    CL Item
    Abnormal  (2)
    CL Item
    Ptosis  (UELPTSIS)
    CL Item
    Retraction  (UELRTRAC)
    CL Item
    Benign eye lid leason  (UELBLLS)
    CL Item
    Other, Specify (?)
    If other finding of right upper eye lid, sepcify
    Item
    If other finding of right upper eye lid, sepcify
    text
    C0229089 (UMLS CUI [1,1])
    C0585636 (UMLS CUI [1,2])
    C0243095 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C2348235 (UMLS CUI [2,3])
    Item
    Right Lower Eye Lid
    text
    C0229089 (UMLS CUI [1,1])
    C2706046 (UMLS CUI [1,2])
    C0205251 (UMLS CUI [1,3])
    Right Lower Eye Lid
    Code List
    Right Lower Eye Lid
    CL Item
    Normal  (1)
    CL Item
    Abnormal (2)
    CL Item
    Entropion  (LELENTP)
    CL Item
    Ectropion  (LELECTP)
    CL Item
    Benign eye lid lesions  (LELBLLS)
    CL Item
    Other, specify (?)
    If other finding of right lower eye lid, specify
    Item
    If other finding of right lower eye lid, specify
    text
    C0229089 (UMLS CUI [1,1])
    C2706046 (UMLS CUI [1,2])
    C0205251 (UMLS CUI [1,3])
    C0243095 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C2348235 (UMLS CUI [2,3])
    Item
    Meibomian Gland Dysfunction Right Eye
    integer
    C1275684 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    Meibomian Gland Dysfunction Right Eye
    Code List
    Meibomian Gland Dysfunction Right Eye
    CL Item
    Absent (0)
    CL Item
    Present (1)
    CL Item
    Mild inspisation/debris without injection or thickening  (11)
    CL Item
    Obvious inspisation/debris, mild injection, no trichiasis or lid thickening  (12)
    CL Item
    Inspisation, debris, obvious injection, lid thickening, may have trichiasis (13)
    Item
    Right Eye Eyelid margin
    text
    C0444582 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    Right Eye Eyelid margin
    Code List
    Right Eye Eyelid margin
    CL Item
    Normal  (N)
    CL Item
    Abnormal  (A)
    CL Item
    Crusting/ discharge  (1)
    CL Item
    Erythema  (2)
    CL Item
    Teleangiectatic blood vessels  (3)
    CL Item
    Other, specify (OT)
    If other finding of eyelid margin of right eye, specify
    Item
    If other finding of eyelid margin of right eye, specify
    text
    C0444582 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    C0243095 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C2348235 (UMLS CUI [2,3])
    Item
    Left Upper Eye Lid
    text
    C0229090 (UMLS CUI [1,1])
    C0585636 (UMLS CUI [1,2])
    Left Upper Eye Lid
    Code List
    Left Upper Eye Lid
    CL Item
    Normal  (1)
    CL Item
    Abnormal  (2)
    CL Item
    Ptosis  (UELPTSIS)
    CL Item
    Retraction  (UELRTRAC)
    CL Item
    Benign eye lid leason  (UELBLLS)
    CL Item
    Other, Specify (?)
    If other finding of left upper eye lid, sepcify
    Item
    If other finding of left upper eye lid, sepcify
    text
    C0229090 (UMLS CUI [1,1])
    C0585636 (UMLS CUI [1,2])
    C0243095 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C2348235 (UMLS CUI [2,3])
    Item
    Left Lower Eye Lid
    text
    C0229090 (UMLS CUI [1,1])
    C2706046 (UMLS CUI [1,2])
    C0205251 (UMLS CUI [1,3])
    Left Lower Eye Lid
    Code List
    Left Lower Eye Lid
    CL Item
    Normal  (1)
    CL Item
    Abnormal  (2)
    CL Item
    Entropion  (LELENTP)
    CL Item
    Ectropion  (LELECTP)
    CL Item
    Benign eye lid lesions  (LELBLLS)
    CL Item
    Other, specify (?)
    If other finding of left lower eye lid, specify
    Item
    If other finding of left lower eye lid, specify
    text
    C0229090 (UMLS CUI [1,1])
    C2706046 (UMLS CUI [1,2])
    C0205251 (UMLS CUI [1,3])
    C0243095 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C2348235 (UMLS CUI [2,3])
    Item
    Meibomian Gland Dysfunction Left Eye
    integer
    C1275684 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    Meibomian Gland Dysfunction Left Eye
    Code List
    Meibomian Gland Dysfunction Left Eye
    CL Item
    Absent (0)
    CL Item
    Present (1)
    CL Item
    Mild inspisation/debris without injection or thickening  (11)
    CL Item
    Obvious inspisation/debris, mild injection, no trichiasis or lid thickening  (12)
    CL Item
    Inspisation, debris, obvious injection, lid thickening, may have trichiasis (13)
    Item
    Left Eye Eyelid margin
    text
    C0444582 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    Left Eye Eyelid margin
    Code List
    Left Eye Eyelid margin
    CL Item
    Normal  (N)
    CL Item
    Abnormal  (A)
    CL Item
    Crusting/ discharge  (1)
    CL Item
    Erythema  (2)
    CL Item
    Teleangiectatic blood vessels  (3)
    CL Item
    Other, specify (OT)
    If other finding of eyelid margin of left eye, specify
    Item
    If other finding of eyelid margin of left eye, specify
    text
    C0444582 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    C0243095 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C2348235 (UMLS CUI [2,3])
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