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23127

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Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

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Versions (2)
  1. 6/12/17 6/12/17 -
  2. 6/25/17 6/25/17 -
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Genentech, Inc.

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June 25, 2017

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Creative Commons BY-NC 3.0
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    NON-SERIOUS ADVERSE EVENT REPORTING (DAY 0 - MONTH 12) CRFs Roche FVF4168G Macular Edema NCT00473330

    English

    NON-SERIOUS ADVERSE EVENT REPORTING (DAY 0 - MONTH 12) CRFs Roche FVF4168G Macular Edema NCT00473330

    1 forms  
    Patient administration
    Description

    Patient administration

    Subject Number
    Description

    PT

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Subject Initials:
    Description

    PTINIT

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1997894
    UMLS CUI [1,2]
    C2986440
    Report Date:
    Description

    VDT

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1302584
    NON-SERIOUS ADVERSE EVENT REPORTING
    Description

    NON-SERIOUS ADVERSE EVENT REPORTING

    Were there any events / illnesses?
    Description

    If Yes, record below.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0877248
    Adverse Event
    Description

    Adverse Event

    PRIMARY ADVERSE EVENT (AE)
    Description

    AE_RAW_TERM [AERAW]

    Data type

    text

    Alias
    UMLS CUI [1]
    C0877248
    Ocular AEs only indicate eye affected:
    Description

    AE_LOCATION [AELOC]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2826797
    UMLS CUI [1,2]
    C0015392
    ONSET
    Description

    AE_ONSET_DT [AEODT]

    Data type

    date

    Measurement units
    • DD/MMM/YY
    Alias
    UMLS CUI [1]
    C2985916
    DD/MMM/YY
    RESOLUTION
    Description

    AE_RESOLVE_DT [AERDT]

    Data type

    date

    Measurement units
    • DD/MMM/YY
    Alias
    UMLS CUI [1]
    C2985918
    DD/MMM/YY
    AE SEVERITY
    Description

    AE_INTENSITY [AEINT]

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2985921
    AE SUSPECTED TO BE CAUSED BY STUDY DRUG? (Investigator’s
    Description

    AE_CAUSE_STUDY_DRUG [AETX]

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1706742
    UMLS CUI [1,2]
    C0304229
    OTHER SUSPECTED CAUSES OF AE None
    Description

    AE_CAUSE_CONCUR_DX [AECDX1]

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1706742
    OTHER SUSPECTED CAUSES OF AE Disease Under Study
    Description

    AE_CAUSE_CONCUR_DX [AECDX2]

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1706742
    OTHER SUSPECTED CAUSES OF AE Withdrawal of Study Drug
    Description

    AE_CAUSE_CONCUR_DX [AECDX3]

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1706742
    OTHER SUSPECTED CAUSES OF AE Concurrent Illness
    Description

    AE_CAUSE_CONCUR_DX [AECDX4]

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1706742
    OTHER SUSPECTED CAUSES OF AE Concomitant Medication
    Description

    AE_CAUSE_CONCUR_DX [AECDX5]

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1706742
    OTHER SUSPECTED CAUSES OF AE Non-Drug Intervention (procedure)
    Description

    AE_CAUSE_CONCUR_DX [AECDX6]

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1706742
    OTHER SUSPECTED CAUSES OF AE Study Drug Injection / Sham Procedure
    Description

    AE_CAUSE_CONCUR_DX [AECDX7]

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1706742
    OTHER SUSPECTED CAUSES OF AE Laser Photocoagulation
    Description

    AE_CAUSE_CONCUR_DX [AECDX8]

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1706742
    ACTION TAKEN WITH STUDY DRUG DUE TO AE
    Description

    AE_ACTION_STUDY_DRUG [AEACTX]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1608430
    TREATMENT FOR AE 1. None
    Description

    AE_TX_MEDICATIONS [AETXMD1]

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2981656
    TREATMENT FOR AE 2. Medications (record on meds CRF)
    Description

    AE_TX_MEDICATIONS [AETXMD2]

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2981656
    TREATMENT FOR AE 3. Procedure / Surgery (record on protocol specific Concurrent Ocular Procedures CRF)
    Description

    AE_TX_MEDICATIONS [AETXMD3]

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2981656
    TREATMENT FOR AE 4. Subject Discontinued from Study
    Description

    AE_TX_MEDICATIONS [AETXMD4]

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2981656
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    Similar models

    NON-SERIOUS ADVERSE EVENT REPORTING (DAY 0 - MONTH 12) CRFs Roche FVF4168G Macular Edema NCT00473330

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Patient administration
    PT
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    PTINIT
    Item
    Subject Initials:
    text
    C1997894 (UMLS CUI [1,1])
    C2986440 (UMLS CUI [1,2])
    VDT
    Item
    Report Date:
    date
    C1302584 (UMLS CUI [1,1])
    Item Group
    NON-SERIOUS ADVERSE EVENT REPORTING
    AE_RECORDS [AEREC]
    Item
    Were there any events / illnesses?
    boolean
    C0262926 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item Group
    Adverse Event
    AE_RAW_TERM [AERAW]
    Item
    PRIMARY ADVERSE EVENT (AE)
    text
    C0877248 (UMLS CUI [1])
    Item
    Ocular AEs only indicate eye affected:
    integer
    C2826797 (UMLS CUI [1,1])
    C0015392 (UMLS CUI [1,2])
    LIGHT_PERCEPTION [LIPEC]
    Code List
    Ocular AEs only indicate eye affected:
    CL Item
    Right (1)
    CL Item
    Left (2)
    AE_ONSET_DT [AEODT]
    Item
    ONSET
    date
    C2985916 (UMLS CUI [1])
    AE_RESOLVE_DT [AERDT]
    Item
    RESOLUTION
    date
    C2985918 (UMLS CUI [1])
    Item
    AE SEVERITY
    integer
    C2985921 (UMLS CUI [1])
    AE_INTENSITY [AEINT]
    Code List
    AE SEVERITY
    CL Item
    Mild (1 )
    CL Item
    Moderate (2 )
    CL Item
    Severe (3 )
    AE_CAUSE_STUDY_DRUG [AETX]
    Item
    AE SUSPECTED TO BE CAUSED BY STUDY DRUG? (Investigator’s
    boolean
    C1706742 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    AE_CAUSE_CONCUR_DX [AECDX1]
    Item
    OTHER SUSPECTED CAUSES OF AE None
    boolean
    C1706742 (UMLS CUI [1])
    AE_CAUSE_CONCUR_DX [AECDX2]
    Item
    OTHER SUSPECTED CAUSES OF AE Disease Under Study
    boolean
    C1706742 (UMLS CUI [1])
    AE_CAUSE_CONCUR_DX [AECDX3]
    Item
    OTHER SUSPECTED CAUSES OF AE Withdrawal of Study Drug
    boolean
    C1706742 (UMLS CUI [1])
    AE_CAUSE_CONCUR_DX [AECDX4]
    Item
    OTHER SUSPECTED CAUSES OF AE Concurrent Illness
    boolean
    C1706742 (UMLS CUI [1])
    AE_CAUSE_CONCUR_DX [AECDX5]
    Item
    OTHER SUSPECTED CAUSES OF AE Concomitant Medication
    boolean
    C1706742 (UMLS CUI [1])
    AE_CAUSE_CONCUR_DX [AECDX6]
    Item
    OTHER SUSPECTED CAUSES OF AE Non-Drug Intervention (procedure)
    boolean
    C1706742 (UMLS CUI [1])
    AE_CAUSE_CONCUR_DX [AECDX7]
    Item
    OTHER SUSPECTED CAUSES OF AE Study Drug Injection / Sham Procedure
    boolean
    C1706742 (UMLS CUI [1])
    AE_CAUSE_CONCUR_DX [AECDX8]
    Item
    OTHER SUSPECTED CAUSES OF AE Laser Photocoagulation
    boolean
    C1706742 (UMLS CUI [1])
    Item
    ACTION TAKEN WITH STUDY DRUG DUE TO AE
    integer
    C0304229 (UMLS CUI [1,1])
    C1608430 (UMLS CUI [1,2])
    AE_ACTION_STUDY_DRUG [AEACTX]
    Code List
    ACTION TAKEN WITH STUDY DRUG DUE TO AE
    CL Item
    None (1)
    CL Item
    Drug Permanently (2)
    CL Item
    Dose Held Discontinued (3)
    CL Item
    Not Applicable (4)
    AE_TX_MEDICATIONS [AETXMD1]
    Item
    TREATMENT FOR AE 1. None
    boolean
    C2981656 (UMLS CUI [1])
    AE_TX_MEDICATIONS [AETXMD2]
    Item
    TREATMENT FOR AE 2. Medications (record on meds CRF)
    boolean
    C2981656 (UMLS CUI [1])
    AE_TX_MEDICATIONS [AETXMD3]
    Item
    TREATMENT FOR AE 3. Procedure / Surgery (record on protocol specific Concurrent Ocular Procedures CRF)
    boolean
    C2981656 (UMLS CUI [1])
    AE_TX_MEDICATIONS [AETXMD4]
    Item
    TREATMENT FOR AE 4. Subject Discontinued from Study
    boolean
    C2981656 (UMLS CUI [1])
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