0 Ratings

ID

5291

Description

EWING 2008, EudraCT 2008-003658-13, http://clinicaltrials.gov/ct2/show/NCT00824083

Link

http://clinicaltrials.gov/ct2/show/NCT00824083

Keywords

  1. 8/4/14 8/4/14 - Martin Dugas
  2. 6/25/15 6/25/15 - Martin Dugas
Uploaded on

August 4, 2014

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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    Ewing Study Add-on R1

    Add-on R1

    1. StudyEvent: SE
      1. Add-on R1
    Show identification of patient
    Description

    Show identification of patient

    Patient
    Description

    Dummy item in ItemGroup 'Display patient'

    Data type

    text

    Body dimensions
    Description

    Body dimensions

    Body height
    Description

    Height

    Data type

    integer

    Measurement units
    • cm
    cm
    Body weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    kg
    Body surface area
    Description

    BSA

    Data type

    float

    Measurement units
    BSA calculated
    Description

    BSA calculated

    Data type

    float

    Measurement units
    Patient < 1 Year or < 10 kg
    Description

    Patient younger than 1 year or weight under 10 kg

    Data type

    integer

    Add-on Kurs
    Description

    Add-on Kurs

    Day 1 of this course
    Description

    Day 1 of course

    Data type

    date

    Course no. (please read help text!)
    Description

    Number of course

    Data type

    integer

    Delay?
    Description

    Verzögerung?

    Data type

    integer

    Schedule deviation in this course
    Description

    Schedule deviation

    Data type

    integer

    Zoledron acid
    Description

    Zoledronsäure

    Data type

    float

    Measurement units
    • mg
    mg
    Dose Zoledron acid acc. to protocol
    Description

    Zoledron acid dose acc. to protocol

    Data type

    float

    Measurement units
    • mg
    mg
    Concurrent radiotherapy
    Description

    Concurrent radiotherapy

    Data type

    integer

    Schedule deviation CTC-Code
    Description

    Schedule deviation CTC-Code

    Reason for schedule deviation
    Description

    Reason for schedule deviation CTC-code

    Data type

    integer

    Similar models

    Add-on R1

    1. StudyEvent: SE
      1. Add-on R1
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Dummy item in ItemGroup 'Display patient'
    Item
    Patient
    text
    Height
    Item
    Body height
    integer
    Weight
    Item
    Body weight
    float
    BSA
    Item
    Body surface area
    float
    BSA calculated
    Item
    BSA calculated
    float
    Item
    Patient < 1 Year or < 10 kg
    integer
    Code List
    Patient < 1 Year or < 10 kg
    CL Item
    No (0)
    CL Item
    Yes (1)
    Item Group
    Day 1 of course
    Item
    Day 1 of this course
    date
    Number of course
    Item
    Course no. (please read help text!)
    integer
    Item
    Delay?
    integer
    Code List
    Delay?
    CL Item
    No (0)
    CL Item
    Yes, due to toxicity of previous course (1)
    CL Item
    Yes, due to other reasons (2)
    Item
    Schedule deviation in this course
    integer
    Code List
    Schedule deviation in this course
    CL Item
    No (0)
    CL Item
    Yes (1)
    Zoledronsäure
    Item
    Zoledron acid
    float
    Zoledron acid dose acc. to protocol
    Item
    Dose Zoledron acid acc. to protocol
    float
    Item
    Concurrent radiotherapy
    integer
    Code List
    Concurrent radiotherapy
    CL Item
    No (0)
    CL Item
    Yes (1)
    Item
    Reason for schedule deviation
    integer
    Code List
    Reason for schedule deviation
    CL Item
    General condition (1)
    CL Item
    Tox. Haemoglobin (11)
    CL Item
    Tox. WBC (12)
    CL Item
    Tox. Granulocytes (13)
    CL Item
    Tox. Platelets (14)
    CL Item
    Tox. Infection (21)
    CL Item
    Tox. Fever (22)
    CL Item
    Tox. Stomatitis (31)
    CL Item
    Tox. Vomiting (32)
    CL Item
    Tox. Diarrhoea (33)
    CL Item
    Tox. Changes in the skin (40)
    CL Item
    Tox. Creatinine (51)
    CL Item
    Tox. Proteinuria (52)
    CL Item
    Tox. Haematuria (53)
    CL Item
    Tox. Glomerular filtration rate (GFR) (54)
    CL Item
    Tox. Tubular phosphate reabsorption (55)
    CL Item
    Tox. Bilirubin (61)
    CL Item
    Tox. SGOT/SGPT (62)
    CL Item
    Tox. Cardiac function (71)
    CL Item
    Tox. ECHO: LV-SF (72)
    CL Item
    Tox. Central neurotoxicity (81)
    CL Item
    Tox. Peripheral neurotoxicity (82)
    CL Item
    Tox. Other toxicity (90)
    CL Item
    Techical problems (93)
    CL Item
    Planning problems (94)
    CL Item
    Patients'/Parents' refusal (95)
    CL Item
    To little weight/to young (96)
    CL Item
    Mistake (97)
    CL Item
    Mobilisation course (98)
    CL Item
    Radiotherapy (99)
    CL Item
    Problem of medication (0)
    CL Item
    Post transplantation course (102)
    CL Item
    Physician choice/clinical decision (use only if not related to another “good” reason that has it’s own code) (103)
    CL Item
    Post amputation (104)

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