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41531

Description

Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

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Versions (2)
  1. 9/23/20 9/23/20 -
  2. 11/2/20 11/2/20 -
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GlaxoSmithKline

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November 2, 2020

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Creative Commons BY 4.0
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    Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162

    English

    Non-Serious Adverse Events; Study Conclusion (Report Final and Annex Report 2 Final)

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Patient Number
    Description

    Patient Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Non-Serious Adverse Event
    Description

    Non-Serious Adverse Event

    Alias
    UMLS CUI-1
    C1518404
    Has any non-serious adverse events been reported during the timeframe as specified in the protocol?
    Description

    Has any non-serious adverse events been reported during the timeframe as specified in the protocol?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1518404
    UMLS CUI [2]
    C2348563
    Non-Serious Adverse Event
    Description

    Non-Serious Adverse Event

    Alias
    UMLS CUI-1
    C1518404
    AE No.
    Description

    AE No.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    Non-Serious Adverse Event Description
    Description

    Non-Serious Adverse Event Description

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0678257
    UMLS CUI [1,2]
    C1518404
    Non-Serious Adverse Event site
    Description

    Non-Serious Adverse Event site

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C1515974
    Please check in case of new onsets of autoimmune diseases or immune-mediated inflammatory disorders (please complete the IMD report)
    Description

    Please check in case of new onsets of autoimmune diseases or immune-mediated inflammatory disorders

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0004364
    UMLS CUI [1,2]
    C0746890
    UMLS CUI [2,1]
    C0012634
    UMLS CUI [2,2]
    C4330477
    Non-Serious Adverse Event Start Date
    Description

    Non-Serious Adverse Event Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0808070
    Non-Serious Adverse Event Start Date during immediate post-administration period (30 minutes)
    Description

    Non-Serious Adverse Event Start Date during immediate post-administration period (30 minutes)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0808070
    UMLS CUI [2,1]
    C3469597
    UMLS CUI [2,2]
    C0687676
    UMLS CUI [2,3]
    C0347984
    Non-Serious Adverse Event Date stopped
    Description

    Non-Serious Adverse Event Date stopped

    Data type

    date

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

    (CTC AE GRADING)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0518690
    UMLS CUI [1,3]
    C0806909
    Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Description

    Relationship to investigational products

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0439849
    Non-Serious Adverse Event Outcome:
    Description

    Non-Serious Adverse Event Outcome:

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C1705586
    Death Form
    Description

    Death Form

    Alias
    UMLS CUI-1
    C0011065
    UMLS CUI-2
    C1516308
    Did the patient die during the study?
    Description

    Did the patient die during the study?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0011065
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C0008976
    Date of death
    Description

    Date of death

    Data type

    date

    Alias
    UMLS CUI [1]
    C1148348
    Was an autopsy performed?
    Description

    Was an autopsy performed?

    Data type

    text

    Alias
    UMLS CUI [1]
    C0004398
    Primary cause of death:
    Description

    (tick only one box)

    Data type

    text

    Alias
    UMLS CUI [1]
    C0007465
    Specify comorbidity
    Description

    Specify comorbidity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C2348235
    Other cause of death, specify
    Description

    Other cause of death, specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0007465
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Study Conclusion - Pregnancy Information
    Description

    Study Conclusion - Pregnancy Information

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008972
    UMLS CUI-3
    C0032961
    UMLS CUI-4
    C1533716
    Did the subject become pregnant during the study?
    Description

    Yes → Complete the Pregnancy notification form.

    Data type

    text

    Alias
    UMLS CUI [1]
    C3828490
    Study Conclusion
    Description

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008972
    Was the patient withdrawn from the study?
    Description

    Was the patient withdrawn from the study?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0422727
    Major reason for withdrawal
    Description

    (tick one box only)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0392360
    Specify SAE No.
    Description

    Specify SAE No.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    Specify AE No.
    Description

    Specify AE No.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    Specify protocol violation
    Description

    Specify protocol viaolation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1709750
    UMLS CUI [1,2]
    C2348235
    Specify other reason for withdrawal
    Description

    Specify other reason for withdrawal

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [2]
    C2348235
    Who made the decision
    Description

    Who made the decision

    Data type

    text

    Alias
    UMLS CUI [1]
    C0679006
    Date of last contact:
    Description

    Date of last contact:

    Data type

    date

    Alias
    UMLS CUI [1]
    C0805839
    Was the patient in good condition at date of last contact (except if patient is dead)?
    Description

    No → Please give details in Adverse Events section

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1142435
    UMLS CUI [1,2]
    C0681850
    Study Conclusion - Investigator's Siganture
    Description

    Study Conclusion - Investigator's Siganture

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008972
    UMLS CUI-3
    C2346576
    UMLS CUI-4
    C0011008
    Investigator's Siganture
    Description

    I confirm that I have reviewed the data in this Case Report Form for this patient. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator's Siganture Date
    Description

    Investigator's Siganture Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Printed Investigator's name:
    Description

    Printed Investigator's name:

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
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    Similar models

    Non-Serious Adverse Events; Study Conclusion (Report Final and Annex Report 2 Final)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Patient Number
    Item
    Patient Number
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Non-Serious Adverse Event
    C1518404 (UMLS CUI-1)
    Has any non-serious adverse events been reported during the timeframe as specified in the protocol?
    Item
    Has any non-serious adverse events been reported during the timeframe as specified in the protocol?
    boolean
    C1518404 (UMLS CUI [1])
    C2348563 (UMLS CUI [2])
    Item Group
    Non-Serious Adverse Event
    C1518404 (UMLS CUI-1)
    AE No.
    Item
    AE No.
    integer
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Non-Serious Adverse Event Description
    Item
    Non-Serious Adverse Event Description
    text
    C0678257 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Item
    Non-Serious Adverse Event site
    text
    C1518404 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    Non-Serious Adverse Event site
    Code List
    Non-Serious Adverse Event site
    CL Item
    Administration site  (L)
    CL Item
    Non-administration site (G)
    Item
    Please check in case of new onsets of autoimmune diseases or immune-mediated inflammatory disorders (please complete the IMD report)
    integer
    C0004364 (UMLS CUI [1,1])
    C0746890 (UMLS CUI [1,2])
    C0012634 (UMLS CUI [2,1])
    C4330477 (UMLS CUI [2,2])
    Please check in case of new onsets of autoimmune diseases or immune-mediated inflammatory disorders
    Code List
    Please check in case of new onsets of autoimmune diseases or immune-mediated inflammatory disorders (please complete the IMD report)
    CL Item
    New onsets of autoimmune diseases or immune-mediated inflammatory disorders (1)
    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 Start Date during immediate post-administration period (30 minutes)
    integer
    C1518404 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    C3469597 (UMLS CUI [2,1])
    C0687676 (UMLS CUI [2,2])
    C0347984 (UMLS CUI [2,3])
    Non-Serious Adverse Event Start Date during immediate post-administration period (30 minutes)
    Code List
    Non-Serious Adverse Event Start Date during immediate post-administration period (30 minutes)
    CL Item
    During immediate post-administration period (1)
    Non-Serious Adverse Event Date stopped
    Item
    Non-Serious Adverse Event Date stopped
    date
    C1518404 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item
    Non-Serious Adverse Event Maximum Intensity:
    integer
    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
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    Relationship to investigational products
    Item
    Relationship to investigational products: 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
    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 (1)
    CL Item
    Recovering / resolving (2)
    CL Item
    Not recovered / not resolved (3)
    CL Item
    Recovered with sequelae / resolved with sequelae (4)
    Item Group
    Death Form
    C0011065 (UMLS CUI-1)
    C1516308 (UMLS CUI-2)
    Did the patient die during the study?
    Item
    Did the patient die during the study?
    boolean
    C0011065 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Date of death
    Item
    Date of death
    date
    C1148348 (UMLS CUI [1])
    Item
    Was an autopsy performed?
    text
    C0004398 (UMLS CUI [1])
    Was an autopsy performed?
    Code List
    Was an autopsy performed?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Unknown (U)
    Item
    Primary cause of death:
    text
    C0007465 (UMLS CUI [1])
    Primary cause of death:
    Code List
    Primary cause of death:
    CL Item
    Disease under study (melanoma) (DI)
    CL Item
    Adverse event related to study medication (AE)
    CL Item
    Comorbidity, please specify (CO)
    CL Item
    Toxicity due to subsequent treatment (TO)
    CL Item
    Other, specify: (OT)
    Specify comorbidity
    Item
    Specify comorbidity
    text
    C0009488 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Other cause of death, specify
    Item
    Other cause of death, specify
    text
    C0007465 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item Group
    Study Conclusion - Pregnancy Information
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    C0032961 (UMLS CUI-3)
    C1533716 (UMLS CUI-4)
    Item
    Did the subject become pregnant during the study?
    text
    C3828490 (UMLS CUI [1])
    Did the subject become pregnant during the study?
    Code List
    Did the subject become pregnant during the study?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    CL Item
    Not applicable (not of childbearing potential or male) (NA)
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    Was the patient withdrawn from the study?
    Item
    Was the patient withdrawn from the study?
    boolean
    C0422727 (UMLS CUI [1])
    Item
    Major reason for withdrawal
    text
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Major reason for withdrawal
    Code List
    Major reason for withdrawal
    CL Item
    Death (any cause) (Please complete Death Form section)  (DEA)
    CL Item
    Serious adverse event (Please complete and submit SAE report. Please specify SAE No.) (SAE)
    CL Item
    Non-Serious adverse event (Please complete Non-serious Adverse Event section. Please specify AE No.) (AEX)
    CL Item
    Protocol violation, please specify (PTV)
    CL Item
    Consent withdrawal, not due to an adverse event  (CWL)
    CL Item
    Migrated / moved from the study area  (MIG)
    CL Item
    Lost to follow-up.  (LFU)
    CL Item
    Other, please specify (OTH)
    Specify SAE No.
    Item
    Specify SAE No.
    integer
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Specify AE No.
    Item
    Specify AE No.
    integer
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Specify protocol viaolation
    Item
    Specify protocol violation
    text
    C1709750 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Specify other reason for withdrawal
    Item
    Specify other reason for withdrawal
    text
    C0422727 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [2])
    Item
    Who made the decision
    text
    C0679006 (UMLS CUI [1])
    Who made the decision
    Code List
    Who made the decision
    CL Item
    Investigator (I)
    CL Item
    Patient (S)
    CL Item
    Both (B)
    Date of last contact:
    Item
    Date of last contact:
    date
    C0805839 (UMLS CUI [1])
    Was the patient in good condition at date of last contact (except if patient is dead)?
    Item
    Was the patient in good condition at date of last contact (except if patient is dead)?
    boolean
    C1142435 (UMLS CUI [1,1])
    C0681850 (UMLS CUI [1,2])
    Item Group
    Study Conclusion - Investigator's Siganture
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    C2346576 (UMLS CUI-3)
    C0011008 (UMLS CUI-4)
    Investigator's Siganture
    Item
    Investigator's Siganture
    text
    C2346576 (UMLS CUI [1])
    Investigator's Siganture Date
    Item
    Investigator's Siganture Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Printed Investigator's name:
    Item
    Printed Investigator's name:
    text
    C2826892 (UMLS CUI [1])
    Back to the top of the page 

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