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41504

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

Keywords

Versions (5)
  1. 9/9/20 9/9/20 -
  2. 9/9/20 9/9/20 -
  3. 9/14/20 9/14/20 -
  4. 9/16/20 9/16/20 -
  5. 10/29/20 10/29/20 -
Copyright Holder

GlaxoSmithKline

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October 29, 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

    Study Treatment Administration; Tumor Assessment; Site evaluation for non-target lesion(s) and new lesions; Target lesion(s) evaluation; Response Assessment (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
    Study Treatment Administration (Visit 1)
    Description

    Study Treatment Administration (Visit 1)

    Alias
    UMLS CUI-1
    C3469597
    UMLS CUI-2
    C0304229
    Has study treatment been administered?
    Description

    No → Please give reason and complete Study Conclusion Yes → Date of administration

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3469597
    UMLS CUI [1,2]
    C0304229
    Date of administration
    Description

    Date of administration

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0011008
    Dose delayed?
    Description

    Dose delayed?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1299700
    Administered Treatment Number
    Description

    Administered Treatment Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C3469597
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C0237753
    Injection Site
    Description

    Injection Site

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2700396
    Injection Side
    Description

    Injection Side

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1272883
    UMLS CUI [1,2]
    C0441987
    Injection Route
    Description

    Injection Route

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013153
    UMLS CUI [1,2]
    C1272883
    If relevant, comment on administration
    Description

    If relevant, comment on administration

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0947611
    If no ASCI, please tick the major reason for non administration
    Description

    If no ASCI, please tick the major reason for non administration

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3469597
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C2826287
    SAE Case No. (no administration)
    Description

    SAE Case No. (no administration)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [2]
    C3469597
    AE No. (no administration)
    Description

    AE No. (no administration)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [2]
    C3469597
    Other reason for no administration
    Description

    Other reason for no administration

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3469597
    UMLS CUI [1,2]
    C2826287
    UMLS CUI [2]
    C0205394
    Please tick who made the decision if no ASCI administration
    Description

    Please tick who made the decision if no ASCI administration

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3469597
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [2]
    C0679006
    Reason for dose delayed
    Description

    Please tick the major reason for non administration

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1299700
    UMLS CUI [1,2]
    C0392360
    SAE Case No. (delay)
    Description

    SAE Case No. (delay)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [2]
    C1299700
    AE No. (delay)
    Description

    AE No. (delay)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [2]
    C1299700
    Other reason for dose delayed
    Description

    Other reason for dose delayed

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1299700
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C0205394
    Study Treatment Administration (Visit 2 - 6, 8 - 13, 15 - 18, 20 - 27)
    Description

    Study Treatment Administration (Visit 2 - 6, 8 - 13, 15 - 18, 20 - 27)

    Alias
    UMLS CUI-1
    C3469597
    UMLS CUI-2
    C0304229
    Has study treatment been administered?
    Description

    No → Please give reason below. Yes → Date of administration

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3469597
    UMLS CUI [1,2]
    C0304229
    Date of administration
    Description

    Date of administration

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0011008
    Dose delayed?
    Description

    Dose delayed?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1299700
    Administered Treatment Number
    Description

    Administered Treatment Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C3469597
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C0237753
    Injection Site
    Description

    Injection Site

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2700396
    Injection Side
    Description

    Injection Side

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1272883
    UMLS CUI [1,2]
    C0441987
    Injection Route
    Description

    Injection Route

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013153
    UMLS CUI [1,2]
    C1272883
    If relevant, comment on administration
    Description

    If relevant, comment on administration

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0947611
    If no ASCI, please tick the major reason for non administration
    Description

    If no ASCI, please tick the major reason for non administration

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3469597
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C2826287
    SAE Case No. (no administration)
    Description

    SAE Case No. (no administration)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [2]
    C3469597
    AE No. (no administration)
    Description

    AE No. (no administration)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [2]
    C3469597
    Other reason for no administration
    Description

    Other reason for no administration

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3469597
    UMLS CUI [1,2]
    C2826287
    UMLS CUI [2]
    C0205394
    Please tick who made the decision if no ASCI administration
    Description

    Please tick who made the decision if no ASCI administration

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3469597
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [2]
    C0679006
    Reason for dose delayed
    Description

    Please tick the major reason for non administration

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1299700
    UMLS CUI [1,2]
    C0392360
    SAE Case No. (delay)
    Description

    SAE Case No. (delay)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [2]
    C1299700
    AE No. (delay)
    Description

    AE No. (delay)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [2]
    C1299700
    Other reason for dose delayed
    Description

    Other reason for dose delayed

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1299700
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C0205394
    Tumor Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
    Description

    Tumor Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)

    Alias
    UMLS CUI-1
    C0006826
    UMLS CUI-2
    C0220825
    Has the tumor assessment been performed?
    Description

    If Yes → Please specify if any of the following assessment have been performed.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0220825
    Tumor Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
    Description

    Tumor Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)

    Alias
    UMLS CUI-1
    C0178874
    UMLS CUI-2
    C0220825
    Examination
    Description

    Examination

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0582103
    Test Done
    Description

    Test Done

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0039593
    Test Date
    Description

    Test Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826247
    Site evaluation for non-target lesion(s) and new lesions (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
    Description

    Site evaluation for non-target lesion(s) and new lesions (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)

    Alias
    UMLS CUI-1
    C0221198
    UMLS CUI-2
    C1518389
    UMLS CUI-3
    C1515974
    UMLS CUI-4
    C0220825
    UMLS CUI-5
    C0221198
    UMLS CUI-6
    C0205314
    Date of evaluation
    Description

    Date of evaluation

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0220825
    UMLS CUI [1,2]
    C0011008
    Site evaluation for non-target lesion(s) and new lesions (Visit 7, 11, 14 ,19, 21, 23 - 28, Follow-up)
    Description

    Site evaluation for non-target lesion(s) and new lesions (Visit 7, 11, 14 ,19, 21, 23 - 28, Follow-up)

    Alias
    UMLS CUI-1
    C0221198
    UMLS CUI-2
    C1518389
    UMLS CUI-3
    C1515974
    UMLS CUI-4
    C0220825
    UMLS CUI-5
    C0221198
    UMLS CUI-6
    C0205314
    Site
    Description

    Site

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1515974
    Method of evaluation
    Description

    Method of evaluation

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2911685
    Other method of evaluation
    Description

    Other method of evaluation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2911685
    UMLS CUI [1,2]
    C0205394
    Response of Non-target lesion
    Description

    Response of Non-target lesion

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C1518389
    UMLS CUI [2]
    C0521982
    New lesion since previous assessment
    Description

    New lesion since previous assessment

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C0205314
    UMLS CUI [2,1]
    C0220825
    UMLS CUI [2,2]
    C0205156
    Target lesion(s) evaluation (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
    Description

    Target lesion(s) evaluation (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)

    Alias
    UMLS CUI-1
    C0221198
    UMLS CUI-2
    C1521840
    UMLS CUI-3
    C0220825
    Lesion No
    Description

    Lesion No

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0237753
    UMLS CUI [1,2]
    C0221198
    Site Target Lesion
    Description

    Site Target Lesion

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1515974
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [1,3]
    C1521840
    Other Site Target Lesion
    Description

    Other Site Target Lesion

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1515974
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [1,3]
    C1521840
    UMLS CUI [1,4]
    C0205394
    Method of Evaluation
    Description

    Method of Evaluation

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2911685
    Other Method of Evaluation
    Description

    Other Method of Evaluation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2911685
    UMLS CUI [1,2]
    C0205394
    Longest Diameter
    Description

    Longest Diameter

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C1301886
    UMLS CUI [1,2]
    C1522425
    mm
    Response Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
    Description

    Response Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)

    Alias
    UMLS CUI-1
    C0521982
    UMLS CUI-2
    C0220825
    What is the response for target lesion?
    Description

    * For patients with all target lesions < 20 mm only (< 10 mm with spiral CT-scan) ** NE = Non Evaluable

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0521982
    UMLS CUI [2,1]
    C0221198
    UMLS CUI [2,2]
    C1521840
    What is the response for non target lesion?
    Description

    * For patients with all target lesions < 20 mm only (< 10 mm with spiral CT-scan) ** NE = Non Evaluable

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C1518389
    UMLS CUI [2]
    C0521982
    What is the overall response at this visit?
    Description

    What is the overall response at this visit?

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1561607
    UMLS CUI [1,2]
    C0871261
    Response date:
    Description

    Response date:

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0521982
    UMLS CUI [1,2]
    C0011008
    If overall response is PD, are the criteria for SPD met?
    Description

    If overall response is PD, are the criteria for SPD met?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3272903
    UMLS CUI [2]
    C0243161
    If response SD, SD / PR, PD, has the patient shown a mixed response?
    Description

    If response SD, SD / PR, PD, has the patient shown a mixed response?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0521982
    UMLS CUI [1,2]
    C0205430
    If the patient has shown a mixed response, specify
    Description

    If the patient has shown a mixed response, specify

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0521982
    UMLS CUI [1,2]
    C0205430
    UMLS CUI [1,3]
    C2348235
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    Similar models

    Study Treatment Administration; Tumor Assessment; Site evaluation for non-target lesion(s) and new lesions; Target lesion(s) evaluation; Response Assessment (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
    Study Treatment Administration (Visit 1)
    C3469597 (UMLS CUI-1)
    C0304229 (UMLS CUI-2)
    Has study treatment been administered?
    Item
    Has study treatment been administered?
    boolean
    C3469597 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Date of administration
    Item
    Date of administration
    date
    C1533734 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Dose delayed?
    Item
    Dose delayed?
    boolean
    C1299700 (UMLS CUI [1])
    Administered Treatment Number
    Item
    Administered Treatment Number
    integer
    C3469597 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    Item
    Injection Site
    integer
    C2700396 (UMLS CUI [1])
    Injection Site
    Code List
    Injection Site
    CL Item
    Deltoid (1)
    CL Item
    Thigh (3)
    CL Item
    Buttock (6)
    Item
    Injection Side
    text
    C1272883 (UMLS CUI [1,1])
    C0441987 (UMLS CUI [1,2])
    Injection Side
    Code List
    Injection Side
    CL Item
    Left (L)
    CL Item
    Right (R)
    Item
    Injection Route
    text
    C0013153 (UMLS CUI [1,1])
    C1272883 (UMLS CUI [1,2])
    Injection Route
    Code List
    Injection Route
    CL Item
    I.M (IM)
    CL Item
    S.C (SC)
    If relevant, comment on administration
    Item
    If relevant, comment on administration
    text
    C1533734 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Item
    If no ASCI, please tick the major reason for non administration
    text
    C3469597 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C2826287 (UMLS CUI [1,3])
    If no ASCI, please tick the major reason for non administration
    Code List
    If no ASCI, please tick the major reason for non administration
    CL Item
    Serious adverse event (Please complete and submit SAE report, please specify SAE Case No.) (SAE)
    CL Item
    Non-Serious adverse event (Please complete Non-serious Adverse Event section, please specify AE No.) (AEX)
    CL Item
    Other, please specify (e.g.: consent eithdrawal, Protocol violation) (OTH)
    SAE Case No. (no administration)
    Item
    SAE Case No. (no administration)
    integer
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C3469597 (UMLS CUI [2])
    AE No. (no administration)
    Item
    AE No. (no administration)
    integer
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C3469597 (UMLS CUI [2])
    Other reason for no administration
    Item
    Other reason for no administration
    text
    C3469597 (UMLS CUI [1,1])
    C2826287 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [2])
    Item
    Please tick who made the decision if no ASCI administration
    text
    C3469597 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C0679006 (UMLS CUI [2])
    Please tick, who made the decision if no ASCI administration
    Code List
    Please tick who made the decision if no ASCI administration
    CL Item
    Investigator (I)
    CL Item
    Patient (S)
    Item
    Reason for dose delayed
    text
    C1299700 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Reason for dose delayed
    Code List
    Reason for dose delayed
    CL Item
    Serious adverse event (Please complete and submit SAE report, please specify SAE CAse No. (SAE)
    CL Item
    Non-serious adverse event (Please complete Non-serious Adverse Event section, please specify AE No.) (AEX)
    CL Item
    Other, please specify (e.g.: consent withdrawal Protocol violation, ....) (OTH)
    SAE Case No. (delay)
    Item
    SAE Case No. (delay)
    integer
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C1299700 (UMLS CUI [2])
    AE No. (delay)
    Item
    AE No. (delay)
    integer
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C1299700 (UMLS CUI [2])
    Other reason for dose delayed
    Item
    Other reason for dose delayed
    text
    C1299700 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Item Group
    Study Treatment Administration (Visit 2 - 6, 8 - 13, 15 - 18, 20 - 27)
    C3469597 (UMLS CUI-1)
    C0304229 (UMLS CUI-2)
    Has study treatment been administered?
    Item
    Has study treatment been administered?
    boolean
    C3469597 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Date of administration
    Item
    Date of administration
    date
    C1533734 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Dose delayed?
    Item
    Dose delayed?
    boolean
    C1299700 (UMLS CUI [1])
    Administered Treatment Number
    Item
    Administered Treatment Number
    integer
    C3469597 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    Item
    Injection Site
    integer
    C2700396 (UMLS CUI [1])
    Injection Site
    Code List
    Injection Site
    CL Item
    Deltoid  (1)
    CL Item
    Thigh  (3)
    CL Item
    Buttock (6)
    Item
    Injection Side
    text
    C1272883 (UMLS CUI [1,1])
    C0441987 (UMLS CUI [1,2])
    Injection Side
    Code List
    Injection Side
    CL Item
    Left  (L)
    CL Item
    Right (R)
    Item
    Injection Route
    text
    C0013153 (UMLS CUI [1,1])
    C1272883 (UMLS CUI [1,2])
    Injection Route
    Code List
    Injection Route
    CL Item
    I.M  (IM)
    CL Item
    S.C (SC)
    If relevant, comment on administration
    Item
    If relevant, comment on administration
    text
    C1533734 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Item
    If no ASCI, please tick the major reason for non administration
    text
    C3469597 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C2826287 (UMLS CUI [1,3])
    If no ASCI, please tick the major reason for non administration
    Code List
    If no ASCI, please tick the major reason for non administration
    CL Item
    Serious adverse event (Please complete and submit SAE report, please specify SAE Case No.) (SAE)
    CL Item
    Non-Serious adverse event (Please complete Non-serious Adverse Event section, please specify AE No.) (AEX)
    CL Item
    Other, please specify (OTH)
    CL Item
    Recurrence/ Progressive disease (PD)
    SAE Case No. (no administration)
    Item
    SAE Case No. (no administration)
    integer
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C3469597 (UMLS CUI [2])
    AE No. (no administration)
    Item
    AE No. (no administration)
    integer
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C3469597 (UMLS CUI [2])
    Other reason for no administration
    Item
    Other reason for no administration
    text
    C3469597 (UMLS CUI [1,1])
    C2826287 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [2])
    Item
    Please tick who made the decision if no ASCI administration
    text
    C3469597 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C0679006 (UMLS CUI [2])
    Please tick who made the decision if no ASCI administration
    Code List
    Please tick who made the decision if no ASCI administration
    CL Item
    Investigator  (I)
    CL Item
    Patient (S)
    Item
    Reason for dose delayed
    text
    C1299700 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Reason for dose delayed
    Code List
    Reason for dose delayed
    CL Item
    Serious adverse event (Please complete and submit SAE report, please specify SAE CAse No. (SAE)
    CL Item
    Non-serious adverse event (Please complete Non-serious Adverse Event section, please specify AE No.) (AEX)
    SAE Case No. (delay)
    Item
    SAE Case No. (delay)
    integer
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C1299700 (UMLS CUI [2])
    AE No. (delay)
    Item
    AE No. (delay)
    integer
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C1299700 (UMLS CUI [2])
    Other reason for dose delayed
    Item
    Other reason for dose delayed
    text
    C1299700 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Item Group
    Tumor Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
    C0006826 (UMLS CUI-1)
    C0220825 (UMLS CUI-2)
    Has the tumor assessment been performed?
    Item
    Has the tumor assessment been performed?
    boolean
    C0006826 (UMLS CUI [1,1])
    C0220825 (UMLS CUI [1,2])
    Item Group
    Tumor Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
    C0178874 (UMLS CUI-1)
    C0220825 (UMLS CUI-2)
    Item
    Examination
    integer
    C0582103 (UMLS CUI [1])
    undefined item
    Code List
    Examination
    CL Item
    Clinical examination (1)
    CL Item
    Chest CT Scan (2)
    CL Item
    Complete Abdomen CT Scan (3)
    CL Item
    Contrast-Enhanced CT Scan of the brain (4)
    CL Item
    Brain MRI (5)
    CL Item
    Ultrasound of lymph node lesions (6)
    CL Item
    Ultrasound of subcutaneous lesions (7)
    CL Item
    Photography of superficial cutaneous lesions (with metrics notation) (8)
    CL Item
    Other, specify (9)
    Test Done
    Item
    Test Done
    boolean
    C0039593 (UMLS CUI [1])
    Test Date
    Item
    Test Date
    date
    C2826247 (UMLS CUI [1])
    Item Group
    Site evaluation for non-target lesion(s) and new lesions (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
    C0221198 (UMLS CUI-1)
    C1518389 (UMLS CUI-2)
    C1515974 (UMLS CUI-3)
    C0220825 (UMLS CUI-4)
    C0221198 (UMLS CUI-5)
    C0205314 (UMLS CUI-6)
    Date of evaluation
    Item
    Date of evaluation
    date
    C0220825 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Site evaluation for non-target lesion(s) and new lesions (Visit 7, 11, 14 ,19, 21, 23 - 28, Follow-up)
    C0221198 (UMLS CUI-1)
    C1518389 (UMLS CUI-2)
    C1515974 (UMLS CUI-3)
    C0220825 (UMLS CUI-4)
    C0221198 (UMLS CUI-5)
    C0205314 (UMLS CUI-6)
    Item
    Site
    integer
    C1515974 (UMLS CUI [1])
    Site
    Code List
    Site
    CL Item
    Primary tumor/recurrence  (1)
    CL Item
    Lymphnode regional  (2)
    CL Item
    Lymphnode distant  (3)
    CL Item
    Cutaneous/subcutaneous regional (4)
    CL Item
    Cutaneous/subcutaneous distant  (5)
    CL Item
    Confluent skin lesions regional  (6)
    CL Item
    Confluent skin lesions distant  (7)
    CL Item
    Lung  (9)
    CL Item
    Brain  (10)
    CL Item
    Other site (99)
    Item
    Method of evaluation
    integer
    C2911685 (UMLS CUI [1])
    Method of evaluation
    Code List
    Method of evaluation
    CL Item
    Photography  (1)
    CL Item
    X-ray  (2)
    CL Item
    Ultrasound  (3)
    CL Item
    Conventional CT-scan  (4)
    CL Item
    Spiral CT-scan  (5)
    CL Item
    MRI  (6)
    CL Item
    Other  (7)
    CL Item
    Clinical examination  (8)
    CL Item
    Not done (9)
    Other method of evaluation
    Item
    Other method of evaluation
    text
    C2911685 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Item
    Response of Non-target lesion
    text
    C0221198 (UMLS CUI [1,1])
    C1518389 (UMLS CUI [1,2])
    C0521982 (UMLS CUI [2])
    Response of Non-target lesion
    Code List
    Response of Non-target lesion
    CL Item
    CR  (CR)
    CL Item
    SD/PR  (SP)
    CL Item
    PD  (PD)
    CL Item
    NE (Non Evaluable)  (NE)
    CL Item
    NA (Not Applicable) (NA)
    New lesion since previous assessment
    Item
    New lesion since previous assessment
    boolean
    C0221198 (UMLS CUI [1,1])
    C0205314 (UMLS CUI [1,2])
    C0220825 (UMLS CUI [2,1])
    C0205156 (UMLS CUI [2,2])
    Item Group
    Target lesion(s) evaluation (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
    C0221198 (UMLS CUI-1)
    C1521840 (UMLS CUI-2)
    C0220825 (UMLS CUI-3)
    Lesion No
    Item
    Lesion No
    integer
    C0237753 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    Item
    Site Target Lesion
    integer
    C1515974 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C1521840 (UMLS CUI [1,3])
    Site Target Lesion
    Code List
    Site Target Lesion
    CL Item
    Primary tumor/recurrence  (1)
    CL Item
    Lymphnode regional  (2)
    CL Item
    Lymphnode distant  (3)
    CL Item
    Cutaneous/subcutaneous regional (4)
    CL Item
    Cutaneous/subcutaneous distant  (5)
    CL Item
    Confluent skin lesions regional  (6)
    CL Item
    Confluent skin lesions distant  (7)
    CL Item
    Other site  (99)
    Other Site Target Lesion
    Item
    Other Site Target Lesion
    text
    C1515974 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C1521840 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    Item
    Method of Evaluation
    integer
    C2911685 (UMLS CUI [1])
    Method of Evaluation
    Code List
    Method of Evaluation
    CL Item
    Photography  (1)
    CL Item
    X-ray  (2)
    CL Item
    Ultrasound  (3)
    CL Item
    Conventional CT-scan  (4)
    CL Item
    Spiral CT-scan  (5)
    CL Item
    MRI  (6)
    CL Item
    Other  (7)
    CL Item
    Clinical examination  (8)
    CL Item
    Not done (9)
    Other Method of Evaluation
    Item
    Other Method of Evaluation
    text
    C2911685 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Longest Diameter
    Item
    Longest Diameter
    integer
    C1301886 (UMLS CUI [1,1])
    C1522425 (UMLS CUI [1,2])
    Item Group
    Response Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
    C0521982 (UMLS CUI-1)
    C0220825 (UMLS CUI-2)
    Item
    What is the response for target lesion?
    integer
    C0521982 (UMLS CUI [1])
    C0221198 (UMLS CUI [2,1])
    C1521840 (UMLS CUI [2,2])
    What is the response for target lesion?
    Code List
    What is the response for target lesion?
    CL Item
    CR (1)
    CL Item
    P R (2)
    CL Item
    SD (3)
    CL Item
    SD / PR* (4)
    CL Item
    PD (5)
    CL Item
    NE** (6)
    Item
    What is the response for non target lesion?
    integer
    C0221198 (UMLS CUI [1,1])
    C1518389 (UMLS CUI [1,2])
    C0521982 (UMLS CUI [2])
    What is the response for non target lesion?
    Code List
    What is the response for non target lesion?
    CL Item
    CR (1)
    CL Item
    S D / P R * (2)
    CL Item
    PD (3)
    CL Item
    NE** (4)
    Item
    What is the overall response at this visit?
    integer
    C1561607 (UMLS CUI [1,1])
    C0871261 (UMLS CUI [1,2])
    What is the overall response at this visit?
    Code List
    What is the overall response at this visit?
    CL Item
    CR (1)
    CL Item
    PR (2)
    CL Item
    SD (3)
    CL Item
    SD/PR* (4)
    CL Item
    PD (5)
    CL Item
    NE** (6)
    Response date:
    Item
    Response date:
    date
    C0521982 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    If overall response is PD, are the criteria for SPD met?
    Item
    If overall response is PD, are the criteria for SPD met?
    boolean
    C3272903 (UMLS CUI [1])
    C0243161 (UMLS CUI [2])
    If response SD, SD / PR, PD, has the patient shown a mixed response?
    Item
    If response SD, SD / PR, PD, has the patient shown a mixed response?
    boolean
    C0521982 (UMLS CUI [1,1])
    C0205430 (UMLS CUI [1,2])
    Item
    If the patient has shown a mixed response, specify
    integer
    C0521982 (UMLS CUI [1,1])
    C0205430 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    If the patient has shown a mixed response, specify
    Code List
    If the patient has shown a mixed response, specify
    CL Item
    SD / PD with target lesion regression (1)
    CL Item
    PR / SD with new lesion (2)
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