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ID

39861

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

Mots-clés

Versions (1)
  1. 24/02/2020 24/02/2020 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

24 février 2020

DOI

Pour une demande vous connecter.

Licence

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

    Anglais

    Subject Logs - Log Status; Concomitant Medications; Non-Serious Adverse Event; Serious Adverse Events

    1 Formulaires  
    Date of Visit/ Assessment
    Description

    Date of Visit/ Assessment

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

    Date of Visit/ Assessment

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C2985720
    Log Status
    Description

    Log Status

    Alias
    UMLS CUI-1
    C1708728
    UMLS CUI-2
    C0449438
    Were any concomitant medications taken by the subject during the study?
    Description

    Were any concomitant medications taken by the subject during the study?

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    UMLS CUI [2,1]
    C0008976
    UMLS CUI [2,2]
    C0347984
    Did the subject experience any non-serious adverse events during the study?
    Description

    Did the subject experience any non-serious adverse events during the study?

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1518404
    UMLS CUI [2,1]
    C0008976
    UMLS CUI [2,2]
    C0347984
    Did the subject experience a serious adverse event during the study?
    Description

    Did the subject experience a serious adverse event during the study?

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    UMLS CUI [2,1]
    C0008976
    UMLS CUI [2,2]
    C0347984
    Did the subject receive any medical/surgical procedures during the study?
    Description

    Did the subject receive any medical/surgical procedures during the study?

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1948041
    UMLS CUI [2,1]
    C0008976
    UMLS CUI [2,2]
    C0347984
    Did the subject experience an incident with GSK medical devices provided for use during this study?
    Description

    If Yes, complete the paper Medical Device Incident Report Form

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0025080
    UMLS CUI [1,2]
    C1551358
    UMLS CUI [2,1]
    C0008976
    UMLS CUI [2,2]
    C0347984
    Concomitant Medications
    Description

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    Concomitant Medications - Sequence Number
    Description

    Concomitant Medications - Sequence Number

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2347852
    UMLS CUI [2]
    C2348184
    Drug Name
    Description

    Trade Name preferred

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0013227
    Concomitant Medications - Modified reported term
    Description

    Concomitant Medications - Modified reported term

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2826819
    GSK Drug synonym
    Description

    GSK Drug synonym

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0871468
    GSK Drug Collection code
    Description

    GSK Drug Collection code

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C1516698
    UMLS CUI [1,3]
    C0805701
    Failed coding
    Description

    Failed coding

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0805701
    UMLS CUI [1,2]
    C0231175
    Unit Dose
    Description

    Unit Dose

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0869039
    Medication Units
    Description

    Medication Units

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C1519795
    Medication Frequency
    Description

    Medication Frequency

    Type de données

    text

    Alias
    UMLS CUI [1]
    C3476109
    Medication Route
    Description

    Medication Route

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0013153
    Is this drug being taken for an ophthalmic indication?
    Description

    Is this drug being taken for an ophthalmic indication?

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0029087
    If this drug has being taken for an ophthalmic indication, specify which eye(s) is/are being treated
    Description

    If this drug has being taken for an ophthalmic indication, specify which eye(s) is/are being treated

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0029087
    UMLS CUI [2]
    C0015392
    UMLS CUI [3]
    C2348235
    Reason for medication
    Description

    Reason for medication

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0013227
    Medication start date
    Description

    Medication start date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2826734
    Is medication ongoing?
    Description

    Is medication ongoing?

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    If medication is not ongoing, specify end date
    Description

    If medication is not ongoing, specify end date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2826666
    UMLS CUI [2]
    C2826744
    Medication type
    Description

    Medication type

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0332307
    Non-Serious Adverse Event
    Description

    Non-Serious Adverse Event

    Alias
    UMLS CUI-1
    C1518404
    Non-Serious Adverse Event Sequence Number
    Description

    Non-Serious Adverse Event Sequence Number

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2348184
    Non-Serious Adverse Event
    Description

    Diagnosis Only (if known) Otherwise Sign/Symptom

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1518404
    Non-Serious Adverse Event - Modified Reported
    Description

    Non-Serious Adverse Event - Modified Reported

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C2826798
    Non-Serious Adverse Event MedDRA synonym
    Description

    Non-Serious Adverse Event MedDRA synonym

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C1140263
    Non-Serious Adverse Event MedDRA lower level term code
    Description

    Non-Serious Adverse Event MedDRA lower level term code

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C3898442
    Non-Serious Adverse Event - Failed coding
    Description

    Non-Serious Adverse Event - Failed coding

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1518404
    UMLS CUI [2,1]
    C0805701
    UMLS CUI [2,2]
    C0231175
    Non-Serious Adverse Event - Start Date
    Description

    Non-Serious Adverse Event - Start Date

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0808070
    Non-Serious Adverse Event Outcome
    Description

    Non-Serious Adverse Event Outcome

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C1705586
    Non-Serious Adverse Event End Date
    Description

    Non-Serious Adverse Event End Date

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0806020
    Non-Serious Adverse Event Frequency
    Description

    Non-Serious Adverse Event Frequency

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0439603
    Non-Serious Adverse Event - Maximum Intensity
    Description

    Record maximum intensity throughout duration of event

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0806909
    Non-Serious Adverse Event - Intensity at onset of event
    Description

    Record intensity at the onset of the event

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0332162
    Non-Serious Adverse Event - Maximum Grade
    Description

    Record maximum grade throughout duration of event

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0441800
    UMLS CUI [1,3]
    C0806909
    Non-Serious Adverse Event - Grade at onset of event
    Description

    Record grade at the onset of the event

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0441800
    UMLS CUI [1,3]
    C0332162
    Non-Serious Adverse Event - Maximum Grade or Intensity
    Description

    Record maximum grade or intensity throughout duration of event

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0441800
    UMLS CUI [1,3]
    C0518690
    UMLS CUI [1,4]
    C0806909
    Non-Serious Adverse Event - Grade or Intensity at onset of event
    Description

    Record grade or intensity at the onset of the event

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0441800
    UMLS CUI [1,4]
    C0332162
    Action Taken with Investigational Product(s) as a Result of the AE
    Description

    Action Taken with Investigational Product(s) as a Result of the AE

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1704758
    UMLS CUI [1,2]
    C1518404
    Non-Serious Adverse Event - Was the subject taking eye drops?
    Description

    Non-Serious Adverse Event - Was the subject taking eye drops?

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0015399
    Record Action Taken with Double Masked Product as a Result of the AE
    Description

    Double masked product = Eye drops

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1704758
    UMLS CUI [1,2]
    C1518404
    Did the subject withdraw from study as a result of this AE?
    Description

    Did the subject withdraw from study as a result of this AE?

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1710677
    UMLS CUI [1,2]
    C1518404
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Description

    Use best judgment at initial entry. May be amended when additional information becomes available. Double masked product = Eye drops

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0439849
    If there is a reasonable possibility that the AE may have been caused by the investigational product, select appropriate investigational product(s)
    Description

    If there is a reasonable possibility that the AE may have been caused by the investigational product, select appropriate investigational product(s)

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0439849
    UMLS CUI [2,1]
    C0304229
    UMLS CUI [2,2]
    C1548787
    Duration of AE if < 24 hours
    Description

    Duration of AE if < 24 hours

    Type de données

    integer

    Unités de mesure
    • h
    Alias
    UMLS CUI [1,1]
    C0449238
    UMLS CUI [1,2]
    C1518404
    h
    Duration of AE if < 24 hours
    Description

    Duration of AE if < 24 hours

    Type de données

    integer

    Unités de mesure
    • min
    Alias
    UMLS CUI [1,1]
    C0449238
    UMLS CUI [1,2]
    C1518404
    min
    Non-Serious Adverse Event - Is this an Ocular Event?
    Description

    Non-Serious Adverse Event - Is this an Ocular Event?

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C1299003
    Non-Serious Adverse Event - If this is an Ocular Event, sepcify
    Description

    Non-Serious Adverse Event - If this is an Ocular Event, sepcify

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C1299003
    UMLS CUI [2]
    C2348235
    Serious Adverse Event - Type of Report
    Description

    Serious Adverse Event - Type of Report

    Alias
    UMLS CUI-1
    C3897642
    UMLS CUI-2
    C0332307
    Initial Report
    Description

    Initial Report

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0684224
    UMLS CUI [1,2]
    C0205265
    Follow-Up Report
    Description

    Follow-Up Report

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C1704685
    Serious Adverse Event - Randomisation
    Description

    Serious Adverse Event - Randomisation

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C0034656
    Did SAE occur after initiation of study medication?
    Description

    Did SAE occur after initiation of study medication?

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0304229
    Serious Adverse Event
    Description

    Serious Adverse Event

    Alias
    UMLS CUI-1
    C1519255
    SAE Sequence Number
    Description

    SAE Sequence Number

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2348184
    Serious Adverse Event
    Description

    Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1519255
    Serious Adverse Event - Modified Term
    Description

    Serious Adverse Event - Modified Term

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2826798
    Serious Adverse Event - MedDRA synonym
    Description

    Serious Adverse Event - MedDRA synonym

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1140263
    Serious Adverse Event - MedDRA lower level term code
    Description

    Serious Adverse Event - MedDRA lower level term code

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C3898442
    Serious Adverse Event - Failed coding
    Description

    Serious Adverse Event - Failed coding

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0805701
    UMLS CUI [1,3]
    C0231175
    Serious Adverse Event - Start Date
    Description

    Serious Adverse Event - Start Date

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0808070
    Serious Adverse Event - Outcome
    Description

    Serious Adverse Event - Outcome

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1705586
    Serious Adverse Event - End Date
    Description

    Serious Adverse Event - End Date

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0806020
    Serious Adverse Event - Maximum Intensity
    Description

    Record maximum intensity throughout duration of event

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0806909
    Serious Adverse Event - Intensity at onset of event
    Description

    Record intensity at the onset of the event

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0332162
    Serious Adverse Event - Maximum Grade
    Description

    Record maximum grade throughout duration of event

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0441800
    UMLS CUI [1,3]
    C0806909
    Serious Adverse Event - Grade at onset of event
    Description

    Record grade at the onset of the event

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0441800
    UMLS CUI [1,3]
    C0332162
    Serious Adverse Event - Maximum Grade or Intensity
    Description

    Record maximum grade or intensity throughout duration of event

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0441800
    UMLS CUI [1,3]
    C0518690
    UMLS CUI [1,4]
    C0806909
    Serious Adverse Event - Grade or Intensity at onset of event
    Description

    Record grade or intensity at the onset of the event

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0441800
    UMLS CUI [1,4]
    C0332162
    Action Taken with Investigational Product(s) as a Result of the SAE
    Description

    Action Taken with Investigational Product(s) as a Result of the SAE

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1704758
    UMLS CUI [1,2]
    C1519255
    Serious Adverse Event - Was the subject taking eye drops?
    Description

    Serious Adverse Event - Was the subject taking eye drops?

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0015399
    Action Taken with ranibizumab as a Result of the SAE
    Description

    Action Taken with ranibizumab as a Result of the SAE

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1704758
    UMLS CUI [1,2]
    C1519255
    UMLS CUI [1,3]
    C1566537
    Serious Adverse Event - Is this an Ocular Event?
    Description

    Serious Adverse Event - Is this an Ocular Event?

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1299003
    Serious Adverse Event - If this is an Ocular Event, sepcify
    Description

    Serious Adverse Event - If this is an Ocular Event, sepcify

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1299003
    UMLS CUI [2]
    C2348235
    Serious Adverse Event - Did the subject withdraw from study as a result of this AE?
    Description

    Serious Adverse Event - Did the subject withdraw from study as a result of this AE?

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1710677
    UMLS CUI [1,2]
    C1519255
    Is there a reasonable possibility that the SAE may have been caused by the investigational product?
    Description

    Use best judgment at initial entry. May be amended when additional information becomes available. Double masked product = Eye drops + boolean

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0439849
    If there is a reasonable possibility that the SAE may have been caused by the investigational product, select appropriate investigational product(s)
    Description

    If there is a reasonable possibility that the SAE may have been caused by the investigational product, select appropriate investigational product(s)

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0439849
    UMLS CUI [2,1]
    C0304229
    UMLS CUI [2,2]
    C1548787
    Duration of SAE if < 24 hours
    Description

    Duration of SAE if < 24 hours

    Type de données

    integer

    Unités de mesure
    • h
    Alias
    UMLS CUI [1,1]
    C0449238
    UMLS CUI [1,2]
    C1519255
    h
    Duration of SAE if < 24 hours
    Description

    Duration of SAE if < 24 hours

    Type de données

    integer

    Unités de mesure
    • min
    Alias
    UMLS CUI [1,1]
    C0449238
    UMLS CUI [1,2]
    C1519255
    min
    Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
    Description

    Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C0439849
    Was the event serious?
    Description

    Was the event serious?

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Serious Adverse Event - Related Investigational Product
    Description

    Serious Adverse Event - Related Investigational Product

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1519255
    UMLS CUI [2]
    C0304229
    Serious Adverse Event - Intensity Changes
    Description

    Serious Adverse Event - Intensity Changes

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C0518690
    UMLS CUI-3
    C0392747
    Serious Adverse Event
    Description

    Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1519255
    Start Date and Time of event segment
    Description

    Start Date and Time of event segment

    Type de données

    datetime

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0449719
    UMLS CUI [1,3]
    C0808070
    UMLS CUI [1,4]
    C1301880
    Intensity of event segment
    Description

    Intensity of event segment

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0449719
    UMLS CUI [1,3]
    C0518690
    Grade of event segment
    Description

    Grade of event segment

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0449719
    UMLS CUI [1,3]
    C0441800
    Grade or Intensity of event segment
    Description

    Grade or Intensity of event segment

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0449719
    UMLS CUI [1,3]
    C0518690
    UMLS CUI [1,4]
    C0441800
    Serious Adverse Event - Seriousness
    Description

    Serious Adverse Event - Seriousness

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C1710056
    Seriousness?
    Description

    Specify the reason for considering this an SAE. Check all that apply.

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1710056
    Serious Adverse Event - Relevant Concomitant/ Treatment Medications
    Description

    Serious Adverse Event - Relevant Concomitant/ Treatment Medications

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C2347852
    UMLS CUI-3
    C2347946
    UMLS CUI-4
    C0304229
    CM Sequence Number
    Description

    CM Sequence Number

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C2348184
    UMLS CUI [1,2]
    C2347852
    Concomitant medication - Drug name
    Description

    Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C2347852
    Concomitant medication - Modified reported term
    Description

    Concomitant medication - Modified reported term

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2826819
    Concomitant medication dose
    Description

    Concomitant medication dose

    Type de données

    float

    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C2347852
    Concomitant medication unit
    Description

    Concomitant medication unit

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C1519795
    Concomitant medication frequency
    Description

    Concomitant medication frequency

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C3476109
    UMLS CUI [1,2]
    C2347852
    Concomitant medication route
    Description

    Medication Route

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0013153
    UMLS CUI [1,2]
    C2347852
    Concomitant medication start date
    Description

    Concomitant medication start date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2826734
    Concomitant Medication ongoing?
    Description

    Concomitant Medication ongoing?

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    If concomitant medication is not ongoing, specify end date.
    Description

    If concomitant medication is not ongoing, specify end date.

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2826744
    Concomitant medication - Primary Indication
    Description

    Enter a medical diagnosis not description

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2826696
    Concomitant medication - Drug type
    Description

    Concomitant medication - Drug type

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0457591
    Serious Adverse Events - Relevant Medical Conditions/ Risk Factors
    Description

    Serious Adverse Events - Relevant Medical Conditions/ Risk Factors

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C0262926
    UMLS CUI-3
    C0035648
    MHx Sequence Number
    Description

    MHx Sequence Number

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C2348184
    UMLS CUI [1,2]
    C0262926
    Specific Condition Name
    Description

    Specific Condition Name

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C2348235
    Medical History - Modified reported term
    Description

    Medical History - Modified reported term

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2826728
    Medical Condition - Date of onset
    Description

    Medical Condition - Date of onset

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0574845
    Medical Condition - Continuing?
    Description

    If no, specify date of last occurrence

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0549178
    Medical Condition - Date of last occurence
    Description

    Medical Condition - Date of last occurence

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C2745955
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C1517741
    Serious Adverse Event - Relevant Diagnostic Results
    Description

    Serious Adverse Event - Relevant Diagnostic Results

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C0430022
    UMLS CUI-3
    C0456984
    Lab Sequence Number
    Description

    Lab Sequence Number

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C2348184
    Test Name
    Description

    Test Name

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0022885
    Test Date
    Description

    Test Date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2826247
    Test Result
    Description

    Test Result

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0587081
    Test Units
    Description

    Test Units

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1519795
    UMLS CUI [1,2]
    C0587081
    Normal Low Range
    Description

    Normal Low Range

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0086715
    UMLS CUI [1,2]
    C0205251
    Normal High Range
    Description

    Normal High Range

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0086715
    UMLS CUI [1,2]
    C0205250
    Relevant diagnostic results not noted above
    Description

    Relevant diagnostic results not noted above

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0587081
    Serious Adverse Event - Rechallenge
    Description

    Serious Adverse Event - Rechallenge

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C2347900
    If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
    Description

    If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0457454
    UMLS CUI [1,3]
    C1519255
    UMLS CUI [1,4]
    C2745955
    Serious Adverse Event - Investigational Product
    Description

    Serious Adverse Event - Investigational Product

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C0304229
    Study Drug
    Description

    Study Drug

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0304229
    Study Drug
    Description

    Study Drug

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0304229
    Study Drug
    Description

    Study Drug

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0304229
    Investigational Product - Start Date
    Description

    Investigational Product - Start Date

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0808070
    Investigational Product - Stop Date
    Description

    Investigational Product - Stop Date

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0806020
    Regimen
    Description

    Regimen

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1276413
    Investigational Product - Dose
    Description

    Investigational Product - Dose

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0678766
    Investigational Product - Cumulative Dose
    Description

    Investigational Product - Cumulative Dose

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C2986497
    General narrative comments
    Description

    General narrative comments

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0947611
    Serious Adverse Event - Non clinical
    Description

    Serious Adverse Event - Non clinical

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C0205210
    Send incomplete SAE data to GSK Safety
    Description

    Send incomplete SAE data to GSK Safety

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1511726
    UMLS CUI [1,3]
    C0205257
    Receipt by GSK date
    Description

    Receipt by GSK date

    Type de données

    datetime

    Alias
    UMLS CUI [1]
    C2985846
    Was the event serious?
    Description

    Was the event serious?

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    SAE Sequence Number
    Description

    SAE Sequence Number

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2348184
    Version Number
    Description

    Version Number

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0333052
    UMLS CUI [1,2]
    C0237753
    Case ID
    Description

    Case ID

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1698493
    UMLS CUI [1,2]
    C0600091
    Randomisation Number
    Description

    Randomisation Number

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    OCEANS Code
    Description

    OCEANS Code

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0805701
    Email Flag
    Description

    Email Flag

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0013849
    Retour au début de la page

    Similar models

    Subject Logs - Log Status; Concomitant Medications; Non-Serious Adverse Event; Serious Adverse Events

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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
    Log Status
    C1708728 (UMLS CUI-1)
    C0449438 (UMLS CUI-2)
    Were any concomitant medications taken by the subject during the study?
    Item
    Were any concomitant medications taken by the subject during the study?
    boolean
    C2347852 (UMLS CUI [1])
    C0008976 (UMLS CUI [2,1])
    C0347984 (UMLS CUI [2,2])
    Did the subject experience any non-serious adverse events during the study?
    Item
    Did the subject experience any non-serious adverse events during the study?
    boolean
    C1518404 (UMLS CUI [1])
    C0008976 (UMLS CUI [2,1])
    C0347984 (UMLS CUI [2,2])
    Did the subject experience a serious adverse event during the study?
    Item
    Did the subject experience a serious adverse event during the study?
    boolean
    C1519255 (UMLS CUI [1])
    C0008976 (UMLS CUI [2,1])
    C0347984 (UMLS CUI [2,2])
    Did the subject receive any medical/surgical procedures during the study?
    Item
    Did the subject receive any medical/surgical procedures during the study?
    boolean
    C1948041 (UMLS CUI [1])
    C0008976 (UMLS CUI [2,1])
    C0347984 (UMLS CUI [2,2])
    Did the subject experience an incident with GSK medical devices provided for use during this study?
    Item
    Did the subject experience an incident with GSK medical devices provided for use during this study?
    boolean
    C0025080 (UMLS CUI [1,1])
    C1551358 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [2,1])
    C0347984 (UMLS CUI [2,2])
    Item Group
    Concomitant Medications
    C2347852 (UMLS CUI-1)
    Concomitant Medications - Sequence Number
    Item
    Concomitant Medications - Sequence Number
    integer
    C2347852 (UMLS CUI [1])
    C2348184 (UMLS CUI [2])
    Drug Name
    Item
    Drug Name
    text
    C0013227 (UMLS CUI [1])
    Concomitant Medications - Modified reported term
    Item
    Concomitant Medications - Modified reported term
    text
    C2826819 (UMLS CUI [1])
    GSK Drug synonym
    Item
    GSK Drug synonym
    text
    C0013227 (UMLS CUI [1,1])
    C0871468 (UMLS CUI [1,2])
    GSK Drug Collection code
    Item
    GSK Drug Collection code
    text
    C0013227 (UMLS CUI [1,1])
    C1516698 (UMLS CUI [1,2])
    C0805701 (UMLS CUI [1,3])
    Failed coding
    Item
    Failed coding
    text
    C0805701 (UMLS CUI [1,1])
    C0231175 (UMLS CUI [1,2])
    Unit Dose
    Item
    Unit Dose
    text
    C0869039 (UMLS CUI [1])
    Item
    Medication Units
    text
    C0013227 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Medication Units
    Code List
    Medication Units
    CL Item
    Actuation  (ACTU)
    CL Item
    Ampoule  (AMP)
    CL Item
    Application  (APP)
    CL Item
    Area under curve  (AUC)
    CL Item
    Bottle  (BOT)
    CL Item
    Capsule  (CAP)
    CL Item
    Cubic centimeter  (CC)
    CL Item
    Cup  (CUP)
    CL Item
    Drops  (GTT)
    CL Item
    Finger tip unit  (FTU)
    CL Item
    Gamma per kilogram per minute  (GA/KG/MIN)
    CL Item
    Gram  (G)
    CL Item
    Grams per kilogram  (G/KG)
    CL Item
    Grams per litre  (G/L)
    CL Item
    Grams per metre squared  (G/M2)
    CL Item
    Grams per metre squared per 12 hours  (G/M2/12HR)
    CL Item
    G/M2/DAYGrams per metre squared per day (G/M2/DAYGrams per metre squared per day)
    CL Item
    Grams per millilitre  (G/ML)
    CL Item
    Inhalation  (INH)
    CL Item
    100 International units/ml  (100IU/ML)
    CL Item
    International units  (IU)
    CL Item
    International units per kilogram  (IU/KG)
    CL Item
    IU/KG/HRInternational units per kilogram per hour (IU/KG/HRInternational units per kilogram per hour)
    CL Item
    International units per millilitre  (IU/ML)
    CL Item
    Litre  (L)
    CL Item
    Litres per minute  (L/MIN)
    CL Item
    Lozenge  (LOZ)
    CL Item
    Mega becquerels (MBq)  (MBQ)
    CL Item
    Megaunits (million units)  (MU)
    CL Item
    Microgram (MCG)  (MCG)
    CL Item
    Microgram (UG) (Microgram (UG))
    CL Item
    Micrograms per gram  (MCG/G)
    CL Item
    Micrograms per hour  (MCG/HR)
    CL Item
    Microgram per kilogram  (MCG/KG)
    CL Item
    Microgram per kilogram per minute  (MCG/KG/MIN)
    CL Item
    Micrograms per millitre  (MCG/ML)
    CL Item
    Micrograms per minute  (MCG/MIN)
    CL Item
    Microlitre  (MCL)
    CL Item
    Micromoles  (UMOL)
    CL Item
    Micromoles per 24 hours  (UMOL/24HR)
    CL Item
    Millicurie  (MCI)
    CL Item
    Milliequivalent  (MEQ)
    CL Item
    Milliequivalents per 24 hours  (MEQ)
    CL Item
    Milligram  (MG)
    CL Item
    Milligram per day  (MG/DAY)
    CL Item
    Milligram per hour  (MG/HR)
    CL Item
    Milligram per kilogram  (MG/KG)
    CL Item
    Milligram per kilogram per hour  (MG/KG/HR)
    CL Item
    Milligram per kilogram per minute  (MG/KG/MIN)
    CL Item
    Milligrams per metre squared  (MG/M2)
    CL Item
    Milligrams per metre squared per day  (MG/M2/DAY)
    CL Item
    Milligrams per millilitre  (MG/ML)
    CL Item
    Milligram per week  (MG/WK)
    CL Item
    Milligrams percent  (MG%)
    CL Item
    Millilitre  (ML)
    CL Item
    Millilitres per hour  (ML/HR)
    CL Item
    Millilitres per minute  (ML/MIN)
    CL Item
    Millimole  (MMOL)
    CL Item
    Millimoles per kilogram  (MMOL/KG)
    CL Item
    Millimoles per millilitre  (MMOL/ML)
    CL Item
    Million international units  (MIU)
    CL Item
    Minimum alveolar concentration  (MAC)
    CL Item
    Nanogram per kilogram per minute  (NG/KG/MIN)
    CL Item
    Nebule  (NEB)
    CL Item
    Ounce  (OZ)
    CL Item
    Pack  (PACK)
    CL Item
    Patch  (PATCH)
    CL Item
    Percent  (%)
    CL Item
    Puff  (PUFF)
    CL Item
    Ring  (RING)
    CL Item
    Sachet  (SACH)
    CL Item
    Spray  (SPR)
    CL Item
    Suppository  (SUPP)
    CL Item
    Tablet  (TAB)
    CL Item
    Tablespoon  (TBLSP)
    CL Item
    Teaspoon  (TSP)
    CL Item
    Units  (U)
    CL Item
    Units per gram  (U/G)
    CL Item
    Units per hour  (U/HR)
    CL Item
    Units per kilogram per minute  (U/KG/MIN)
    CL Item
    Units per minute  (U/MIN)
    CL Item
    Unknown  (UNK)
    CL Item
    Vial (VIAL)
    Item
    Medication Frequency
    text
    C3476109 (UMLS CUI [1])
    Medication Frequency
    Code List
    Medication Frequency
    CL Item
    2 times per week  (2XWK)
    CL Item
    3 times per week (3XWK)
    CL Item
    4 times per week  (4XWK)
    CL Item
    5 times per day  (5XD)
    CL Item
    5 times per week  (5XWK)
    CL Item
    AC  (AC)
    CL Item
    BID  (BID)
    CL Item
    Continuous infusion  (CINF)
    CL Item
    HS  (HS)
    CL Item
    Once daily  (OD)
    CL Item
    Once only  (ONE)
    CL Item
    PC  (PC)
    CL Item
    PRN  (PRN)
    CL Item
    Q12H  (Q12H)
    CL Item
    Q2H  (Q2H)
    CL Item
    Every 2 weeks (Q2WK)
    CL Item
    Q3D  (Q3D)
    CL Item
    Every 3 months (Q3M)
    CL Item
    Every 3 weeks  (Q3WK)
    CL Item
    Q4D  (Q4D)
    CL Item
    Q4H  (Q4H)
    CL Item
    Q6H  (Q6H)
    CL Item
    Q8H  (Q8H)
    CL Item
    QAM  (QAM)
    CL Item
    QH  (QH)
    CL Item
    QID  (QID)
    CL Item
    Once a month  (QM)
    CL Item
    Every other day  (QOD)
    CL Item
    QPM  (QPM)
    CL Item
    Once a week  (QWK)
    CL Item
    TID  (TID)
    CL Item
    Unknown (UNK)
    Item
    Medication Route
    text
    C0013153 (UMLS CUI [1])
    Medication Route
    Code List
    Medication Route
    CL Item
    Intra-arterial  (IA)
    CL Item
    Intra-articular  (IART)
    CL Item
    Intra-bursa  (IB)
    CL Item
    Intradermal  (ID)
    CL Item
    Inhalation  (IH)
    CL Item
    Intramuscular  (IM)
    CL Item
    Injection  (INJ)
    CL Item
    Intravenous  (IV)
    CL Item
    Nasal  (NS)
    CL Item
    Otic  (OT)
    CL Item
    Other  (OTH)
    CL Item
    Oral  (PO)
    CL Item
    Rectal  (PR)
    CL Item
    Subcutaneous  (SC)
    CL Item
    Sublingual  (SL)
    CL Item
    Transdermal  (TD)
    CL Item
    Topical  (TP)
    CL Item
    Unknown  (UNK)
    CL Item
    Vaginal (VG)
    Is this drug being taken for an ophthalmic indication?
    Item
    Is this drug being taken for an ophthalmic indication?
    boolean
    C0013227 (UMLS CUI [1,1])
    C0029087 (UMLS CUI [1,2])
    Item
    If this drug has being taken for an ophthalmic indication, specify which eye(s) is/are being treated
    text
    C0013227 (UMLS CUI [1,1])
    C0029087 (UMLS CUI [1,2])
    C0015392 (UMLS CUI [2])
    C2348235 (UMLS CUI [3])
    If this drug has being taken for an ophthalmic indication, specify which eye(s) is/are being treated
    Code List
    If this drug has being taken for an ophthalmic indication, specify which eye(s) is/are being treated
    CL Item
    Left (OS) (L)
    CL Item
    Right (OD) (R)
    CL Item
    Both eyes (B)
    Reason for medication
    Item
    Reason for medication
    text
    C0392360 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Medication start date
    Item
    Medication start date
    date
    C2826734 (UMLS CUI [1])
    Is medication ongoing?
    Item
    Is medication ongoing?
    boolean
    C2826666 (UMLS CUI [1])
    If medication is not ongoing, specify end date
    Item
    If medication is not ongoing, specify end date
    date
    C2826666 (UMLS CUI [1])
    C2826744 (UMLS CUI [2])
    Medication type
    Item
    Medication type
    text
    C0013227 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Item Group
    Non-Serious Adverse Event
    C1518404 (UMLS CUI-1)
    Non-Serious Adverse Event Sequence Number
    Item
    Non-Serious Adverse Event Sequence Number
    integer
    C1519255 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Non-Serious Adverse Event
    Item
    Non-Serious Adverse Event
    text
    C1518404 (UMLS CUI [1])
    Non-Serious Adverse Event - Modified Reported
    Item
    Non-Serious Adverse Event - Modified Reported
    text
    C1518404 (UMLS CUI [1,1])
    C2826798 (UMLS CUI [1,2])
    Non-Serious Adverse Event MedDRA synonym
    Item
    Non-Serious Adverse Event MedDRA synonym
    text
    C1518404 (UMLS CUI [1,1])
    C1140263 (UMLS CUI [1,2])
    Non-Serious Adverse Event MedDRA lower level term code
    Item
    Non-Serious Adverse Event MedDRA lower level term code
    text
    C1518404 (UMLS CUI [1,1])
    C3898442 (UMLS CUI [1,2])
    Non-Serious Adverse Event - Failed coding
    Item
    Non-Serious Adverse Event - Failed coding
    text
    C1518404 (UMLS CUI [1])
    C0805701 (UMLS CUI [2,1])
    C0231175 (UMLS CUI [2,2])
    Non-Serious Adverse Event - Start Date
    Item
    Non-Serious Adverse Event - Start Date
    date
    C1518404 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Item
    Non-Serious Adverse Event Outcome
    integer
    C1518404 (UMLS CUI [1,1])
    C1705586 (UMLS CUI [1,2])
    Non-Serious Adverse Event Outcome
    Code List
    Non-Serious Adverse Event Outcome
    CL Item
    Recovered/Resolved, provide End Date (1)
    CL Item
    Recovering/Resolving (2)
    CL Item
    Not recovered/Not resolved (3)
    CL Item
    Recovered/Resolved with sequelae, provide End Date (4)
    Non-Serious Adverse Event End Date
    Item
    Non-Serious Adverse Event End Date
    date
    C1518404 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item
    Non-Serious Adverse Event Frequency
    integer
    C1518404 (UMLS CUI [1,1])
    C0439603 (UMLS CUI [1,2])
    Non-Serious Adverse Event Frequency
    Code List
    Non-Serious Adverse Event Frequency
    CL Item
    Single Episode (1)
    CL Item
    Intermittent (2)
    Item
    Non-Serious Adverse Event - Maximum Intensity
    text
    C1518404 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0806909 (UMLS CUI [1,3])
    Non-Serious Adverse Event - Maximum Intensity
    Code List
    Non-Serious Adverse Event - Maximum Intensity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    Not applicable (X)
    Item
    Non-Serious Adverse Event - Intensity at onset of event
    text
    C1518404 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0332162 (UMLS CUI [1,3])
    Non-Serious Adverse Event - Intensity at onset of event
    Code List
    Non-Serious Adverse Event - Intensity at onset of event
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    Not applicable (X)
    Item
    Non-Serious Adverse Event - Maximum Grade
    integer
    C1518404 (UMLS CUI [1,1])
    C0441800 (UMLS CUI [1,2])
    C0806909 (UMLS CUI [1,3])
    Non-Serious Adverse Event - Maximum Grade
    Code List
    Non-Serious Adverse Event - Maximum Grade
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    Item
    Non-Serious Adverse Event - Grade at onset of event
    integer
    C1518404 (UMLS CUI [1,1])
    C0441800 (UMLS CUI [1,2])
    C0332162 (UMLS CUI [1,3])
    Non-Serious Adverse Event - Grade at onset of event
    Code List
    Non-Serious Adverse Event - Grade at onset of event
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    Non-Serious Adverse Event - Maximum Grade or Intensity
    text
    C1518404 (UMLS CUI [1,1])
    C0441800 (UMLS CUI [1,2])
    C0518690 (UMLS CUI [1,3])
    C0806909 (UMLS CUI [1,4])
    Non-Serious Adverse Event - Maximum Grade or Intensity
    Code List
    Non-Serious Adverse Event - Maximum Grade or Intensity
    CL Item
    Mild or Grade 1 (1)
    CL Item
    Moderate or Grade 2 (2)
    CL Item
    Severe or Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    CL Item
    Not applicable (X)
    Item
    Non-Serious Adverse Event - Grade or Intensity at onset of event
    text
    C1518404 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0441800 (UMLS CUI [1,3])
    C0332162 (UMLS CUI [1,4])
    Non-Serious Adverse Event - Grade or Intensity at onset of event
    Code List
    Non-Serious Adverse Event - Grade or Intensity at onset of event
    CL Item
    Mild or Grade 1 (1)
    CL Item
    Moderate or Grade 2 (2)
    CL Item
    Severe or Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    CL Item
    Not applicable (X)
    Item
    Action Taken with Investigational Product(s) as a Result of the AE
    text
    C1704758 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Action Taken with Investigational Product(s) as a Result of the AE
    Code List
    Action Taken with Investigational Product(s) as a Result of the AE
    CL Item
    Investigational product(s) withdrawn (1)
    CL Item
    Dose reduced (2)
    CL Item
    Dose increased (3)
    CL Item
    Dose not changed (4)
    CL Item
    Dose interrupted (5)
    CL Item
    Not applicable (X)
    Non-Serious Adverse Event - Was the subject taking eye drops?
    Item
    Non-Serious Adverse Event - Was the subject taking eye drops?
    boolean
    C1518404 (UMLS CUI [1,1])
    C0015399 (UMLS CUI [1,2])
    Item
    Record Action Taken with Double Masked Product as a Result of the AE
    integer
    C1704758 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Record Action Taken with Double Masked Product as a Result of the AE
    Code List
    Record Action Taken with Double Masked Product as a Result of the AE
    CL Item
    Investigational product(s) withdrawn (1)
    CL Item
    Dose reduced (2)
    CL Item
    Dose increased (3)
    CL Item
    Dose not changed (4)
    CL Item
    Dose interrupted (5)
    Did the subject withdraw from study as a result of this AE?
    Item
    Did the subject withdraw from study as a result of this AE?
    boolean
    C1710677 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Item
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    boolean
    C1518404 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [1,3])
    Item
    If there is a reasonable possibility that the AE may have been caused by the investigational product, select appropriate investigational product(s)
    integer
    C1518404 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [1,3])
    C0304229 (UMLS CUI [2,1])
    C1548787 (UMLS CUI [2,2])
    If there is a reasonable possibility that the AE may have been caused by the investigational product, select appropriate investigational product(s)
    Code List
    If there is a reasonable possibility that the AE may have been caused by the investigational product, select appropriate investigational product(s)
    CL Item
    Ranibizumab (113)
    CL Item
    Double masked product (114)
    CL Item
    Ranibizumab/Double masked product (115)
    Duration of AE if < 24 hours
    Item
    Duration of AE if < 24 hours
    integer
    C0449238 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Duration of AE if < 24 hours
    Item
    Duration of AE if < 24 hours
    integer
    C0449238 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Non-Serious Adverse Event - Is this an Ocular Event?
    Item
    Non-Serious Adverse Event - Is this an Ocular Event?
    boolean
    C1518404 (UMLS CUI [1,1])
    C1299003 (UMLS CUI [1,2])
    Item
    Non-Serious Adverse Event - If this is an Ocular Event, sepcify
    text
    C1518404 (UMLS CUI [1,1])
    C1299003 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [2])
    If this is an Ocular Event, sepcify
    Code List
    Non-Serious Adverse Event - If this is an Ocular Event, sepcify
    CL Item
    Right Eye (R)
    CL Item
    Left Eye (L)
    Item Group
    Serious Adverse Event - Type of Report
    C3897642 (UMLS CUI-1)
    C0332307 (UMLS CUI-2)
    Item
    Initial Report
    integer
    C0684224 (UMLS CUI [1,1])
    C0205265 (UMLS CUI [1,2])
    Initial Report
    Code List
    Initial Report
    CL Item
    Initial (1)
    Item
    Follow-Up Report
    integer
    C1704685 (UMLS CUI [1])
    Follow-Up Report
    Code List
    Follow-Up Report
    CL Item
    Follow-Up (2)
    Item Group
    Serious Adverse Event - Randomisation
    C1519255 (UMLS CUI-1)
    C0034656 (UMLS CUI-2)
    Did SAE occur after initiation of study medication?
    Item
    Did SAE occur after initiation of study medication?
    boolean
    C1519255 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Item Group
    Serious Adverse Event
    C1519255 (UMLS CUI-1)
    SAE Sequence Number
    Item
    SAE Sequence Number
    integer
    C1519255 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Serious Adverse Event
    Item
    Serious Adverse Event
    text
    C1519255 (UMLS CUI [1])
    Serious Adverse Event - Modified Term
    Item
    Serious Adverse Event - Modified Term
    text
    C1519255 (UMLS CUI [1,1])
    C2826798 (UMLS CUI [1,2])
    Serious Adverse Event - MedDRA synonym
    Item
    Serious Adverse Event - MedDRA synonym
    text
    C1519255 (UMLS CUI [1,1])
    C1140263 (UMLS CUI [1,2])
    Serious Adverse Event - MedDRA lower level term code
    Item
    Serious Adverse Event - MedDRA lower level term code
    text
    C1519255 (UMLS CUI [1,1])
    C3898442 (UMLS CUI [1,2])
    Serious Adverse Event - Failed coding
    Item
    Serious Adverse Event - Failed coding
    text
    C1519255 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    C0231175 (UMLS CUI [1,3])
    Serious Adverse Event - Start Date
    Item
    Serious Adverse Event - Start Date
    date
    C1519255 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Item
    Serious Adverse Event - Outcome
    integer
    C1519255 (UMLS CUI [1,1])
    C1705586 (UMLS CUI [1,2])
    Serious Adverse Event - Outcome
    Code List
    Serious Adverse Event - Outcome
    CL Item
    Recovered/Resolved, provide End Date (1)
    CL Item
    Recovering/Resolving (2)
    CL Item
    Not recovered/Not resolved (3)
    CL Item
    Recovered/Resolved with sequelae, provide End Date (4)
    CL Item
    Fatal, record Date of Death (5)
    Serious Adverse Event - End Date
    Item
    Serious Adverse Event - End Date
    date
    C1519255 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item
    Serious Adverse Event - Maximum Intensity
    text
    C1519255 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0806909 (UMLS CUI [1,3])
    Serious Adverse Event - Maximum Intensity
    Code List
    Serious Adverse Event - Maximum Intensity
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe  (3)
    CL Item
    Not applicable (X)
    Item
    Serious Adverse Event - Intensity at onset of event
    text
    C1519255 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0332162 (UMLS CUI [1,3])
    Serious Adverse Event - Intensity at onset of event
    Code List
    Serious Adverse Event - Intensity at onset of event
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe  (3)
    CL Item
    Not applicable (X)
    Item
    Serious Adverse Event - Maximum Grade
    integer
    C1519255 (UMLS CUI [1,1])
    C0441800 (UMLS CUI [1,2])
    C0806909 (UMLS CUI [1,3])
    Serious Adverse Event - Maximum Grade
    Code List
    Serious Adverse Event - Maximum Grade
    CL Item
    Grade 1  (1)
    CL Item
    Grade 2  (2)
    CL Item
    Grade 3  (3)
    CL Item
    Grade 4 (4)
    Item
    Serious Adverse Event - Grade at onset of event
    integer
    C1519255 (UMLS CUI [1,1])
    C0441800 (UMLS CUI [1,2])
    C0332162 (UMLS CUI [1,3])
    Serious Adverse Event - Grade at onset of event
    Code List
    Serious Adverse Event - Grade at onset of event
    CL Item
    Grade 1  (1)
    CL Item
    Grade 2  (2)
    CL Item
    Grade 3  (3)
    CL Item
    Grade 4  (4)
    CL Item
    Grade 5 (5)
    Item
    Serious Adverse Event - Maximum Grade or Intensity
    text
    C1519255 (UMLS CUI [1,1])
    C0441800 (UMLS CUI [1,2])
    C0518690 (UMLS CUI [1,3])
    C0806909 (UMLS CUI [1,4])
    Serious Adverse Event - Maximum Grade or Intensity
    Code List
    Serious Adverse Event - Maximum Grade or Intensity
    CL Item
    Mild or Grade 1  (1)
    CL Item
    Moderate or Grade 2  (2)
    CL Item
    Severe or Grade 3  (3)
    CL Item
    Grade 4  (4)
    CL Item
    Grade 5  (5)
    CL Item
    Not applicable (X)
    Item
    Serious Adverse Event - Grade or Intensity at onset of event
    text
    C1519255 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    C0441800 (UMLS CUI [1,3])
    C0332162 (UMLS CUI [1,4])
    Serious Adverse Event - Grade or Intensity at onset of event
    Code List
    Serious Adverse Event - Grade or Intensity at onset of event
    CL Item
    Mild or Grade 1  (1)
    CL Item
    Moderate or Grade 2  (2)
    CL Item
    Severe or Grade 3  (3)
    CL Item
    Grade 4  (4)
    CL Item
    Grade 5  (5)
    CL Item
    Not applicable (X)
    Item
    Action Taken with Investigational Product(s) as a Result of the SAE
    text
    C1704758 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Action Taken with Investigational Product(s) as a Result of the SAE
    Code List
    Action Taken with Investigational Product(s) as a Result of the SAE
    CL Item
    Investigational product(s) withdrawn  (1)
    CL Item
    Dose reduced  (2)
    CL Item
    Dose increased  (3)
    CL Item
    Dose not changed  (4)
    CL Item
    Dose interrupted  (5)
    CL Item
    Not applicable (X)
    Serious Adverse Event - Was the subject taking eye drops?
    Item
    Serious Adverse Event - Was the subject taking eye drops?
    boolean
    C1519255 (UMLS CUI [1,1])
    C0015399 (UMLS CUI [1,2])
    Item
    Action Taken with ranibizumab as a Result of the SAE
    text
    C1704758 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    C1566537 (UMLS CUI [1,3])
    Action Taken with ranibizumab as a Result of the SAE
    Code List
    Action Taken with ranibizumab as a Result of the SAE
    CL Item
    Investigational product(s) withdrawn (1)
    CL Item
    Dose reduced (2)
    CL Item
    Dose increased (3)
    CL Item
    Dose not changed (4)
    CL Item
    Dose interrupted (5)
    CL Item
    Not applicable (X)
    Serious Adverse Event - Is this an Ocular Event?
    Item
    Serious Adverse Event - Is this an Ocular Event?
    boolean
    C1519255 (UMLS CUI [1,1])
    C1299003 (UMLS CUI [1,2])
    Item
    Serious Adverse Event - If this is an Ocular Event, sepcify
    text
    C1519255 (UMLS CUI [1,1])
    C1299003 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [2])
    Serious Adverse Event - If this is an Ocular Event, sepcify
    Code List
    Serious Adverse Event - If this is an Ocular Event, sepcify
    CL Item
    Right Eye  (R)
    CL Item
    Left Eye (L)
    Serious Adverse Event - Did the subject withdraw from study as a result of this AE?
    Item
    Serious Adverse Event - Did the subject withdraw from study as a result of this AE?
    boolean
    C1710677 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Is there a reasonable possibility that the SAE may have been caused by the investigational product?
    Item
    Is there a reasonable possibility that the SAE may have been caused by the investigational product?
    boolean
    C1519255 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [1,3])
    Item
    If there is a reasonable possibility that the SAE may have been caused by the investigational product, select appropriate investigational product(s)
    integer
    C1519255 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [1,3])
    C0304229 (UMLS CUI [2,1])
    C1548787 (UMLS CUI [2,2])
    If there is a reasonable possibility that the SAE may have been caused by the investigational product, select appropriate investigational product(s)
    Code List
    If there is a reasonable possibility that the SAE may have been caused by the investigational product, select appropriate investigational product(s)
    CL Item
    Ranibizumab  (113)
    CL Item
    Double masked product  (114)
    CL Item
    Ranibizumab/Double masked product (115)
    Duration of SAE if < 24 hours
    Item
    Duration of SAE if < 24 hours
    integer
    C0449238 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Duration of SAE if < 24 hours
    Item
    Duration of SAE if < 24 hours
    integer
    C0449238 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
    Item
    Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
    boolean
    C1519255 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [1,3])
    Was the event serious?
    Item
    Was the event serious?
    boolean
    C1519255 (UMLS CUI [1])
    Serious Adverse Event - Related Investigational Product
    Item
    Serious Adverse Event - Related Investigational Product
    text
    C1519255 (UMLS CUI [1])
    C0304229 (UMLS CUI [2])
    Item Group
    Serious Adverse Event - Intensity Changes
    C1519255 (UMLS CUI-1)
    C0518690 (UMLS CUI-2)
    C0392747 (UMLS CUI-3)
    Serious Adverse Event
    Item
    Serious Adverse Event
    text
    C1519255 (UMLS CUI [1])
    Start Date and Time of event segment
    Item
    Start Date and Time of event segment
    datetime
    C1519255 (UMLS CUI [1,1])
    C0449719 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    C1301880 (UMLS CUI [1,4])
    Item
    Intensity of event segment
    integer
    C1519255 (UMLS CUI [1,1])
    C0449719 (UMLS CUI [1,2])
    C0518690 (UMLS CUI [1,3])
    Intensity of event segment
    Code List
    Intensity of event segment
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Grade of event segment
    integer
    C1519255 (UMLS CUI [1,1])
    C0449719 (UMLS CUI [1,2])
    C0441800 (UMLS CUI [1,3])
    Grade of event segment
    Code List
    Grade of event segment
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    Grade or Intensity of event segment
    integer
    C1518404 (UMLS CUI [1,1])
    C0449719 (UMLS CUI [1,2])
    C0518690 (UMLS CUI [1,3])
    C0441800 (UMLS CUI [1,4])
    Grade or Intensity of event segment
    Code List
    Grade or Intensity of event segment
    CL Item
    Mild or Grade 1 (1)
    CL Item
    Moderate or Grade 2 (2)
    CL Item
    Severe or Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item Group
    Serious Adverse Event - Seriousness
    C1519255 (UMLS CUI-1)
    C1710056 (UMLS CUI-2)
    Item
    Seriousness?
    text
    C1519255 (UMLS CUI [1,1])
    C1710056 (UMLS CUI [1,2])
    Seriousness?
    Code List
    Seriousness?
    CL Item
    Results in death (A)
    CL Item
    Is life-threatening (B)
    CL Item
    Requires hospitalisation or prolongation of existing hospitalisation (C)
    CL Item
    Results in disability/incapacity (D)
    CL Item
    Congenital anomaly/birth defect (E)
    CL Item
    Other, specify within general narrative comment (F)
    CL Item
    All events of possible drug-induced liver injury with hyperbilirubinaemia defined as ALT >= 3xULN and bilirubin >= 2xULN (>35% direct) (or ALT >= 3xULN and INR>1.5, if INR measured) termed 'Hy's Law' events. (G)
    Item Group
    Serious Adverse Event - Relevant Concomitant/ Treatment Medications
    C1519255 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    C2347946 (UMLS CUI-3)
    C0304229 (UMLS CUI-4)
    CM Sequence Number
    Item
    CM Sequence Number
    integer
    C2348184 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Concomitant medication - Drug name
    Item
    Concomitant medication - Drug name
    text
    C0013227 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Concomitant medication - Modified reported term
    Item
    Concomitant medication - Modified reported term
    text
    C2826819 (UMLS CUI [1])
    Concomitant medication dose
    Item
    Concomitant medication dose
    float
    C3174092 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Item
    Concomitant medication unit
    text
    C2347852 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Medication Unit
    Code List
    Concomitant medication unit
    CL Item
    Actuation  (ACTU)
    CL Item
    Ampoule  (AMP)
    CL Item
    Application  (AP)
    CL Item
    Bottle  (BT)
    CL Item
    Capsule  (CAP)
    CL Item
    Cubic centimeter (CC)
    CL Item
    Drops  (031)
    CL Item
    Gram  (002)
    CL Item
    International units  (025)
    CL Item
    International units per kilogram  (028)
    CL Item
    International units per millilitre  (IUML)
    CL Item
    Litre  (011)
    CL Item
    Litre per minute  (LM)
    CL Item
    Lozenge  (LOZ)
    CL Item
    Megaunits (million units)  (MEGU)
    CL Item
    Microgram (UG)  (004)
    CL Item
    Microgram (UG)  (004)
    CL Item
    Microgram/kilogram  (008)
    CL Item
    Microgram/kilogram per minute  (MCG/KG/MIN)
    CL Item
    Micrograms per minute  (MCG/MIN)
    CL Item
    Microlitre  (013)
    CL Item
    Milliequivalent  (029)
    CL Item
    Milliequivalent per 24 hours  (MEQ24)
    CL Item
    Milligram  (003)
    CL Item
    Milligrams percent  (MGPER)
    CL Item
    Milligram per hour  (MGH)
    CL Item
    Milligram/kilogram  (007)
    CL Item
    Milligram/kilogram per hour  (MGKH)
    CL Item
    Milligram/kilogram per minute  (MGKM)
    CL Item
    Milligram/metre squared  (009)
    CL Item
    Milligram/millilitre  (MGML)
    CL Item
    Millilitre  (012)
    CL Item
    Millilitre per hour  (MLH)
    CL Item
    Millilitre per minute  (MLM)
    CL Item
    Millimole  (023)
    CL Item
    Million international units  (027)
    CL Item
    Minimum alveolar concentration  (MAC)
    CL Item
    Nebule  (NEB)
    CL Item
    Patch  (PAT)
    CL Item
    Percent  (030)
    CL Item
    Puff  (PUFF)
    CL Item
    Sachet  (SAC)
    CL Item
    Spray  (SPR)
    CL Item
    Suppository  (SUP)
    CL Item
    Tablespoon  (TBS)
    CL Item
    Tablet  (TAB)
    CL Item
    Teaspoon  (TSP)
    CL Item
    Units  (UNT)
    CL Item
    Unknown  (U)
    CL Item
    Vial (VIA)
    Item
    Concomitant medication frequency
    text
    C3476109 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Medication Frequency
    Code List
    Concomitant medication frequency
    CL Item
    2 times per week  (2W)
    CL Item
    3 times per week  (3W)
    CL Item
    4 times per week  (4W)
    CL Item
    5 times per day  (5D)
    CL Item
    5 times per week  (5W)
    CL Item
    AC  (AC)
    CL Item
    Q12H  (2D)
    CL Item
    Continuous infusion  (CO)
    CL Item
    Every 2 weeks  (FO)
    CL Item
    Every 3 weeks  (Q3W)
    CL Item
    Every 3 months  (Q3M)
    CL Item
    Every other day  (AD)
    CL Item
    QPM  (1N)
    CL Item
    Once a month  (MO)
    CL Item
    Once a week  (WE)
    CL Item
    Once daily  (1D)
    CL Item
    Once only  (1S)
    CL Item
    PC  (PC)
    CL Item
    PRN  (PRN)
    CL Item
    Q2H  (12D)
    CL Item
    Q3D  (Q3D)
    CL Item
    Q4D  (Q4D)
    CL Item
    Q4H  (6D)
    CL Item
    QID  (4D)
    CL Item
    TID  (3D)
    CL Item
    Q12H  (2D)
    CL Item
    QAM  (1M)
    CL Item
    QH  (24D)
    CL Item
    QID  (4D)
    CL Item
    QPM  (1N)
    CL Item
    TID  (3D)
    CL Item
    Unknown (U)
    Item
    Concomitant medication route
    text
    C0013153 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Medication Route
    Code List
    Concomitant medication route
    CL Item
    Both eyes  (047)
    CL Item
    Epidural  (008)
    CL Item
    Gastrostomy tube  (GT)
    CL Item
    Inhalation  (055)
    CL Item
    Injection  (INJ)
    CL Item
    Intra-arterial  (013)
    CL Item
    Intra-bursa  (IBU)
    CL Item
    Intralesional  (026)
    CL Item
    Intramuscular  (030)
    CL Item
    Nasal  (045)
    CL Item
    Intraocular  (031)
    CL Item
    Intraosteal  (IOS)
    CL Item
    Intraperitoneal  (033)
    CL Item
    Intrathecal  (037)
    CL Item
    Intrauterine  (015)
    CL Item
    Intravenous  (042)
    CL Item
    Nasal  (045)
    CL Item
    Oral  (048)
    CL Item
    Rectal  (054)
    CL Item
    Subcutaneous  (058)
    CL Item
    Sublingual  (060)
    CL Item
    Topical  (061)
    CL Item
    Transdermal  (062)
    CL Item
    Unknown  (065)
    CL Item
    Vaginal (067)
    Concomitant medication start date
    Item
    Concomitant medication start date
    date
    C2826734 (UMLS CUI [1])
    Concomitant Medication ongoing?
    Item
    Concomitant Medication ongoing?
    boolean
    C2826666 (UMLS CUI [1])
    If concomitant medication is not ongoing, specify end date.
    Item
    If concomitant medication is not ongoing, specify end date.
    date
    C2826744 (UMLS CUI [1])
    Concomitant medication - Primary Indication
    Item
    Concomitant medication - Primary Indication
    text
    C2826696 (UMLS CUI [1])
    Item
    Concomitant medication - Drug type
    text
    C2347852 (UMLS CUI [1,1])
    C0457591 (UMLS CUI [1,2])
    Concomitant medication - Drug type
    Code List
    Concomitant medication - Drug type
    CL Item
    Concomitant  (2)
    CL Item
    Treatment  (T)
    CL Item
    Cause of SAE (1)
    Item Group
    Serious Adverse Events - Relevant Medical Conditions/ Risk Factors
    C1519255 (UMLS CUI-1)
    C0262926 (UMLS CUI-2)
    C0035648 (UMLS CUI-3)
    MHx Sequence Number
    Item
    MHx Sequence Number
    integer
    C2348184 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    Specific Condition Name
    Item
    Specific Condition Name
    text
    C0012634 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Medical History - Modified reported term
    Item
    Medical History - Modified reported term
    text
    C2826728 (UMLS CUI [1])
    Medical Condition - Date of onset
    Item
    Medical Condition - Date of onset
    date
    C0012634 (UMLS CUI [1,1])
    C0574845 (UMLS CUI [1,2])
    Item
    Medical Condition - Continuing?
    text
    C0012634 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Medical Condition - Continuing?
    Code List
    Medical Condition - Continuing?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Unknown (U)
    Medical Condition - Date of last occurence
    Item
    Medical Condition - Date of last occurence
    date
    C0012634 (UMLS CUI [1,1])
    C2745955 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C1517741 (UMLS CUI [1,4])
    Item Group
    Serious Adverse Event - Relevant Diagnostic Results
    C1519255 (UMLS CUI-1)
    C0430022 (UMLS CUI-2)
    C0456984 (UMLS CUI-3)
    Lab Sequence Number
    Item
    Lab Sequence Number
    integer
    C0022885 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Item
    Test Name
    integer
    C0022885 (UMLS CUI [1])
    Test Name
    Code List
    Test Name
    CL Item
    Activated partial thromboplastin time (1)
    CL Item
    Albumin (2)
    CL Item
    Alkaline phosphatase (3)
    CL Item
    Amylase (4)
    CL Item
    Basophils (5)
    CL Item
    Bicarbonate (6)
    CL Item
    Bilirubin (7)
    CL Item
    Bilirubin direct (8)
    CL Item
    Bilirubin total (9)
    CL Item
    Blood myoglobin (10)
    CL Item
    Blood pH (11)
    CL Item
    Blood pressure (12)
    CL Item
    Blood urea nitrogen (13)
    CL Item
    Body temperature (14)
    CL Item
    Calcium (15)
    CL Item
    CD4 lymphocytes (16)
    CL Item
    CD8 lymphocytes (17)
    CL Item
    Chloride (18)
    CL Item
    Cholesterol total (19)
    CL Item
    C-reactive protein (20)
    CL Item
    Creatine (21)
    CL Item
    Creatine phosphokinase (22)
    CL Item
    Creatine phosphokinase MB (23)
    CL Item
    Creatinine (24)
    CL Item
    Creatinine clearance (25)
    CL Item
    Diastolic blood pressure (26)
    CL Item
    Eosinophils (27)
    CL Item
    Erythrocyte sedimentation rate (28)
    CL Item
    Fasting blood glucose (29)
    CL Item
    FEV 1 (30)
    CL Item
    Gamma-glutamyltransferase (31)
    CL Item
    Glutamic-oxaloacetic transferase (32)
    CL Item
    Glutamic-pyruvate transaminase (33)
    CL Item
    HbA1c (34)
    CL Item
    HBV-DNA decreased (35)
    CL Item
    HBV-DNA increased (36)
    CL Item
    Heart rate (37)
    CL Item
    Hematocrit (38)
    CL Item
    Hemoglobin (39)
    CL Item
    High density lipoprotein (40)
    CL Item
    HIV viral load (41)
    CL Item
    INR (42)
    CL Item
    Lactic dehydrogenase (43)
    CL Item
    Lipase (44)
    CL Item
    Low density lipoprotein (45)
    CL Item
    Lymphocytes (46)
    CL Item
    Magnesium (47)
    CL Item
    Mean cell hemoglobin concentration (48)
    CL Item
    Mean corpuscular hemoglobin (49)
    CL Item
    Mean corpuscular volume (50)
    CL Item
    Monocytes (51)
    CL Item
    Neutrophils (52)
    CL Item
    Oxygen saturation (53)
    CL Item
    pCO2 (54)
    CL Item
    pH (55)
    CL Item
    Phosphate (56)
    CL Item
    Platelet count (57)
    CL Item
    pO2 (58)
    CL Item
    Potassium (59)
    CL Item
    Protein total (60)
    CL Item
    Prothrombin time (61)
    CL Item
    Red blood cell count (62)
    CL Item
    Respiratory rate (63)
    CL Item
    Reticulocyte count (64)
    CL Item
    Serum glucose (65)
    CL Item
    Serum uric acid (66)
    CL Item
    Sodium (67)
    CL Item
    Systolic blood pressure (68)
    CL Item
    Thrombin time (69)
    CL Item
    Total lung capacity (70)
    CL Item
    Triglycerides (71)
    CL Item
    Troponin (72)
    CL Item
    Troponin I (73)
    CL Item
    Troponin T (74)
    CL Item
    Urine myoglobin (75)
    CL Item
    Urine pH (76)
    CL Item
    Vital capacity (77)
    CL Item
    White blood cell count (78)
    Test Date
    Item
    Test Date
    date
    C2826247 (UMLS CUI [1])
    Test Result
    Item
    Test Result
    text
    C0587081 (UMLS CUI [1])
    Test Units
    Item
    Test Units
    text
    C1519795 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    Normal Low Range
    Item
    Normal Low Range
    integer
    C0086715 (UMLS CUI [1,1])
    C0205251 (UMLS CUI [1,2])
    Normal High Range
    Item
    Normal High Range
    integer
    C0086715 (UMLS CUI [1,1])
    C0205250 (UMLS CUI [1,2])
    Relevant diagnostic results not noted above
    Item
    Relevant diagnostic results not noted above
    text
    C0587081 (UMLS CUI [1])
    Item Group
    Serious Adverse Event - Rechallenge
    C1519255 (UMLS CUI-1)
    C2347900 (UMLS CUI-2)
    Item
    If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
    text
    C0304229 (UMLS CUI [1,1])
    C0457454 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    C2745955 (UMLS CUI [1,4])
    If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
    Code List
    If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
    CL Item
    N0 (N)
    CL Item
    Yes (Y)
    CL Item
    Unknown at this time (U)
    CL Item
    Not applicable (X)
    Item Group
    Serious Adverse Event - Investigational Product
    C1519255 (UMLS CUI-1)
    C0304229 (UMLS CUI-2)
    Item
    Study Drug
    integer
    C0304229 (UMLS CUI [1])
    Study Drug
    Code List
    Study Drug
    CL Item
    Double masked product (1)
    CL Item
    Ranibizumab (as needed) (2)
    CL Item
    Monthly IVT ranibizumab (3)
    Item
    Study Drug
    integer
    C0304229 (UMLS CUI [1])
    Study Drug
    Code List
    Study Drug
    CL Item
    Dose level 1 (1)
    CL Item
    Dose level 2 (2)
    CL Item
    Dose level 3 (3)
    Item
    Study Drug
    integer
    C0304229 (UMLS CUI [1])
    Study Drug
    Code List
    Study Drug
    CL Item
    Course 1 (1)
    CL Item
    Course 2 (2)
    CL Item
    Course 3 (3)
    Investigational Product - Start Date
    Item
    Investigational Product - Start Date
    date
    C0304229 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Investigational Product - Stop Date
    Item
    Investigational Product - Stop Date
    date
    C0304229 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Regimen
    Item
    Regimen
    text
    C1276413 (UMLS CUI [1])
    Investigational Product - Dose
    Item
    Investigational Product - Dose
    text
    C0304229 (UMLS CUI [1,1])
    C0678766 (UMLS CUI [1,2])
    Investigational Product - Cumulative Dose
    Item
    Investigational Product - Cumulative Dose
    text
    C0304229 (UMLS CUI [1,1])
    C2986497 (UMLS CUI [1,2])
    General narrative comments
    Item
    General narrative comments
    text
    C1519255 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Item Group
    Serious Adverse Event - Non clinical
    C1519255 (UMLS CUI-1)
    C0205210 (UMLS CUI-2)
    Item
    Send incomplete SAE data to GSK Safety
    text
    C1519255 (UMLS CUI [1,1])
    C1511726 (UMLS CUI [1,2])
    C0205257 (UMLS CUI [1,3])
    Send incomplete SAE data to GSK Safety
    Code List
    Send incomplete SAE data to GSK Safety
    CL Item
    Incomplete SAE (3)
    Receipt by GSK date
    Item
    Receipt by GSK date
    datetime
    C2985846 (UMLS CUI [1])
    Was the event serious?
    Item
    Was the event serious?
    boolean
    C1519255 (UMLS CUI [1])
    SAE Sequence Number
    Item
    SAE Sequence Number
    integer
    C1519255 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Version Number
    Item
    Version Number
    text
    C0333052 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Case ID
    Item
    Case ID
    text
    C1698493 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Randomisation Number
    Item
    Randomisation Number
    text
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    OCEANS Code
    Item
    OCEANS Code
    text
    C0805701 (UMLS CUI [1])
    Email Flag
    Item
    Email Flag
    text
    C0013849 (UMLS CUI [1])
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