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42033

Beschreibung

Study Description Stamm: International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Documentation. Clinical Trial Number: NCT01117441.

Stichworte

  1. 31.05.16 31.05.16 -
  2. 15.03.21 15.03.21 - Dr. rer. medic Philipp Neuhaus
Hochgeladen am

15. März 2021

DOI

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Creative Commons BY-NC-ND 3.0

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    SAE documentation AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441

    SAE documentation AIEOP-BFM ALL 2009 NCT01117441

    Patient Information
    Beschreibung

    Patient Information

    Alias
    UMLS CUI-1
    C1955348 (Patient Information)
    Patient Study ID
    Beschreibung

    Patient Study ID

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Patient Date of Birth
    Beschreibung

    Patient Date of Birth

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0421451 (Patient date of birth)
    SNOMED
    184099003
    LOINC
    LP57552-9
    Therapy
    Beschreibung

    Therapy

    Alias
    UMLS CUI-1
    C0039798 (therapeutic aspects)
    Specify Protocol I:
    Beschreibung

    Protocol I

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2348563 (Study Protocol)
    UMLS CUI [1,2]
    C0205435 (First (number))
    SNOMED
    255216001
    LOINC
    LP96880-7
    Specify Methotrexate protocol:
    Beschreibung

    Methotrexate protocol

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2348563 (Study Protocol)
    UMLS CUI [1,2]
    C0025677 (methotrexate)
    SNOMED
    68887009
    Specify Protocol II:
    Beschreibung

    Protocol II

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2348563 (Study Protocol)
    UMLS CUI [1,2]
    C0205436 (second (number))
    SNOMED
    81170007
    LOINC
    LP35057-6
    Specify high risk block:
    Beschreibung

    High risk block

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0684030 (high-risk group)
    UMLS CUI [1,2]
    C0039798 (therapeutic aspects)
    Specify interval therapy:
    Beschreibung

    Interval therapy

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1272706 (Interval)
    SNOMED
    385673002
    UMLS CUI [1,2]
    C0039798 (therapeutic aspects)
    Specify maintenance therapy:
    Beschreibung

    Maintenance therapy

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0677908 (Maintenance therapy)
    SNOMED
    314122007
    Specify other therapeutic aspects:
    Beschreibung

    Other therapeutic aspects

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0039798 (therapeutic aspects)
    UMLS CUI [1,2]
    C2348235 (Specification)
    Therapy start date
    Beschreibung

    Therapy start date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C3173309 (Date treatment or therapy started)
    LOINC
    LP262646-5
    Severe adverse event: reported SAE must meet criteria 1) at least one of the following (a) death of patient, b) life-threatening, c) not planned hospitalization or necessary prelongiation of stay, d) conditions which may lead to disability, e) congenital anomaly or malformations in descendants) 2. other for study relevant toxicities
    Beschreibung

    Severe adverse event: reported SAE must meet criteria 1) at least one of the following (a) death of patient, b) life-threatening, c) not planned hospitalization or necessary prelongiation of stay, d) conditions which may lead to disability, e) congenital anomaly or malformations in descendants) 2. other for study relevant toxicities

    Alias
    UMLS CUI-1
    C1519275 (Grade 3 Severe Adverse Event)
    SNOMED
    446431000124107
    Severe adverse event: Infection
    Beschreibung

    Infection

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    Severe adverse event: Infection: If "Yes", has it been reported?
    Beschreibung

    Infection: reporting

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    UMLS CUI [1,2]
    C0700287 (Reporting)
    SNOMED
    223458004
    Severe adverse event: Pancreas
    Beschreibung

    Pancreas

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0030274 (Pancreas)
    SNOMED
    15776009
    LOINC
    LP21208-1
    Severe adverse event: Pancreas: If "Yes", has it been reported?
    Beschreibung

    Pancreas: reporting

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0030274 (Pancreas)
    SNOMED
    15776009
    LOINC
    LP21208-1
    UMLS CUI [1,2]
    C0700287 (Reporting)
    SNOMED
    223458004
    Severe adverse event: Thrombosis
    Beschreibung

    Thrombosis

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0040053 (Thrombosis)
    SNOMED
    118927008
    LOINC
    LP31622-1
    Severe adverse event: Thrombosis: If "Yes", has it been reported?
    Beschreibung

    Thrombosis: reporting

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0040053 (Thrombosis)
    SNOMED
    118927008
    LOINC
    LP31622-1
    UMLS CUI [1,2]
    C0700287 (Reporting)
    SNOMED
    223458004
    Severe adverse event: Liver
    Beschreibung

    Liver

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023884 (Liver)
    SNOMED
    10200004
    LOINC
    LP29289-3
    Severe adverse event: Liver: If "Yes", has it been reported?
    Beschreibung

    Liver: reporting

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0023884 (Liver)
    SNOMED
    10200004
    LOINC
    LP29289-3
    UMLS CUI [1,2]
    C0700287 (Reporting)
    SNOMED
    223458004
    Severe adverse event: Neurologic/ Psychologic aspects
    Beschreibung

    Neurologic/ Psychologic aspects

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0027763 (Nervous system structure)
    SNOMED
    25087005
    LOINC
    LP7441-1
    UMLS CUI [2]
    C0205486 (Psychologic)
    SNOMED
    60224009
    LOINC
    LA16974-0
    Severe adverse event: Neurologic/ Psychologic aspects: If "Yes", has it been reported?
    Beschreibung

    Neurologic/ Psychologic aspects: reporting

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0027763 (Nervous system structure)
    SNOMED
    25087005
    LOINC
    LP7441-1
    UMLS CUI [1,2]
    C0700287 (Reporting)
    SNOMED
    223458004
    UMLS CUI [2,1]
    C0205486 (Psychologic)
    SNOMED
    60224009
    LOINC
    LA16974-0
    UMLS CUI [2,2]
    C0700287 (Reporting)
    SNOMED
    223458004
    Severe adverse event: Gastrointestinal aspects
    Beschreibung

    Gastrointestinal aspects

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0012240 (Gastrointestinal system)
    SNOMED
    86762007
    LOINC
    LP7256-3
    Severe adverse event: Gastrointestinal aspects: If "Yes", has it been reported?
    Beschreibung

    Gastrointestinal aspects: reporting

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012240 (Gastrointestinal system)
    SNOMED
    86762007
    LOINC
    LP7256-3
    UMLS CUI [1,2]
    C0700287 (Reporting)
    SNOMED
    223458004
    Severe adverse event: Dermatologic aspects
    Beschreibung

    Dermatologic aspects

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0037274 (Dermatologic disorders)
    SNOMED
    95320005
    Severe adverse event: Dermatologic aspects: If "Yes", has it been reported?
    Beschreibung

    Dermatologic aspects: reporting

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0037274 (Dermatologic disorders)
    SNOMED
    95320005
    UMLS CUI [1,2]
    C0700287 (Reporting)
    SNOMED
    223458004
    Severe adverse event: Cardiac aspects
    Beschreibung

    Cardiac aspects

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1522601 (Cardiac - anatomy qualifier)
    Severe adverse event: Cardiac aspects: If "Yes", has it been reported?
    Beschreibung

    Cardiac aspects: reporting

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1522601 (Cardiac - anatomy qualifier)
    UMLS CUI [1,2]
    C0700287 (Reporting)
    SNOMED
    223458004
    Severe adverse event: Renal aspects
    Beschreibung

    Renal aspects

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0022646 (Kidney)
    SNOMED
    64033007
    LOINC
    LP34712-7
    Severe adverse event: Renal aspects: If "Yes", has it been reported?
    Beschreibung

    Renal aspects: reporting

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0022646 (Kidney)
    SNOMED
    64033007
    LOINC
    LP34712-7
    UMLS CUI [1,2]
    C0700287 (Reporting)
    SNOMED
    223458004
    Severe adverse event: Metabolic/ endocrinologic aspects
    Beschreibung

    Metabolic/ endocrinologic aspects

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0025517 (Metabolic Diseases)
    SNOMED
    30390004
    UMLS CUI [2]
    C0694557 (endocrinologic)
    Severe adverse event: Metabolic/ endocrinologic aspects: If "Yes", has it been reported?
    Beschreibung

    Metabolic/ endocrinologic aspects: reporting

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0025517 (Metabolic Diseases)
    SNOMED
    30390004
    UMLS CUI [1,2]
    C0700287 (Reporting)
    SNOMED
    223458004
    UMLS CUI [2,1]
    C0694557 (endocrinologic)
    UMLS CUI [2,2]
    C0700287 (Reporting)
    SNOMED
    223458004
    Severe adverse event: Drug intolerance
    Beschreibung

    Drug intolerance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0277585 (Intolerance to drug)
    SNOMED
    59037007
    Severe adverse event: Drug intolerance: If "Yes", has it been reported?
    Beschreibung

    Drug intolerance: reporting

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0277585 (Intolerance to drug)
    SNOMED
    59037007
    UMLS CUI [1,2]
    C0700287 (Reporting)
    SNOMED
    223458004
    Severe adverse event: Skeleton aspects
    Beschreibung

    Skeleton aspects

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0816871 (Skeleton)
    Severe adverse event: Skeleton aspects: If "Yes", has it been reported?
    Beschreibung

    Skeleton aspects: reporting

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0816871 (Skeleton)
    UMLS CUI [1,2]
    C0700287 (Reporting)
    SNOMED
    223458004
    Severe adverse event: Not classified aspects
    Beschreibung

    Not classified aspects

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0205426 (Unclassified general adjectival modifiers)
    SNOMED
    1491000
    LOINC
    LA6680-8
    Severe adverse event: Not classified aspects: If "Yes", has it been reported?
    Beschreibung

    Not classified aspects: reporting

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0205426 (Unclassified general adjectival modifiers)
    SNOMED
    1491000
    LOINC
    LA6680-8
    UMLS CUI [1,2]
    C0700287 (Reporting)
    SNOMED
    223458004
    Identification and Signature
    Beschreibung

    Identification and Signature

    Alias
    UMLS CUI-1
    C0205396 (Identified)
    SNOMED
    7882003
    LOINC
    LP72776-5
    UMLS CUI-2
    C1519316 (Signature)
    LOINC
    LP248948-4
    Date of report
    Beschreibung

    Date of report

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302584 (Date of report)
    SNOMED
    399651003
    Docotor's name
    Beschreibung

    Doctor's name

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0027365 (Name)
    SNOMED
    703503000
    LOINC
    LP72974-6
    UMLS CUI [1,2]
    C0031831 (Physicians)
    SNOMED
    158965000
    LOINC
    LA18968-0
    Doctor's signature
    Beschreibung

    Doctor's signature

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1519316 (Signature)
    LOINC
    LP248948-4

    Ähnliche Modelle

    SAE documentation AIEOP-BFM ALL 2009 NCT01117441

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Patient Information
    C1955348 (UMLS CUI-1)
    Patient Study ID
    Item
    text
    C2348585 (UMLS CUI [1])
    Patient Date of Birth
    Item
    Patient Date of Birth
    date
    C0421451 (UMLS CUI [1])
    Item Group
    Therapy
    C0039798 (UMLS CUI-1)
    Item
    Specify Protocol I:
    text
    C2348563 (UMLS CUI [1,1])
    C0205435 (UMLS CUI [1,2])
    Code List
    Specify Protocol I:
    CL Item
    Prot. IA (Prot. IA)
    CL Item
    Prot. IAD (Prot. IAD)
    CL Item
    Prot. IA' (Prot. IA')
    CL Item
    Prot. IA-CPM (Prot. IA-CPM)
    CL Item
    Prot. IB (Prot. IB)
    CL Item
    Prot. IB-ASP+ (Prot. IB-ASP+)
    Item
    Specify Methotrexate protocol:
    text
    C2348563 (UMLS CUI [1,1])
    C0025677 (UMLS CUI [1,2])
    Code List
    Specify Methotrexate protocol:
    CL Item
    1st HD-MTX (1st HD-MTX)
    CL Item
    2nd HD-MTX (2nd HD-MTX)
    CL Item
    3rd HD-MTX (3rd HD-MTX)
    CL Item
    4th HD-MTX (4th HD-MTX)
    Item
    Specify Protocol II:
    text
    C2348563 (UMLS CUI [1,1])
    C0205436 (UMLS CUI [1,2])
    Code List
    Specify Protocol II:
    CL Item
    Prot. IIA (Prot. IIA)
    CL Item
    Prot. IIA-ASP+ (Prot. IIA-ASP+)
    CL Item
    Prot. IIB (Prot. IIB)
    CL Item
    Prot. IIB-ASP+ (Prot. IIB-ASP+)
    Item
    Specify high risk block:
    text
    C0684030 (UMLS CUI [1,1])
    C0039798 (UMLS CUI [1,2])
    Code List
    Specify high risk block:
    CL Item
    HR-1' (HR-1')
    CL Item
    HR-2' (HR-2')
    CL Item
    HR-3' (HR-3')
    CL Item
    DNX-FLA (DNX-FLA)
    Item
    Specify interval therapy:
    text
    C1272706 (UMLS CUI [1,1])
    C0039798 (UMLS CUI [1,2])
    Code List
    Specify interval therapy:
    CL Item
    1st interval therapy (1st interval therapy)
    CL Item
    2nd interval therapy (2nd interval therapy)
    Item
    Specify maintenance therapy:
    text
    C0677908 (UMLS CUI [1])
    Code List
    Specify maintenance therapy:
    CL Item
    Maintenance therapy (Maintenance therapy)
    Other therapeutic aspects
    Item
    Specify other therapeutic aspects:
    text
    C0039798 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Therapy start date
    Item
    Therapy start date
    date
    C3173309 (UMLS CUI [1])
    Item Group
    Severe adverse event: reported SAE must meet criteria 1) at least one of the following (a) death of patient, b) life-threatening, c) not planned hospitalization or necessary prelongiation of stay, d) conditions which may lead to disability, e) congenital anomaly or malformations in descendants) 2. other for study relevant toxicities
    C1519275 (UMLS CUI-1)
    Infection
    Item
    Severe adverse event: Infection
    boolean
    C0009450 (UMLS CUI [1])
    Infection: reporting
    Item
    Severe adverse event: Infection: If "Yes", has it been reported?
    boolean
    C0009450 (UMLS CUI [1,1])
    C0700287 (UMLS CUI [1,2])
    Pancreas
    Item
    Severe adverse event: Pancreas
    boolean
    C0030274 (UMLS CUI [1])
    Pancreas: reporting
    Item
    Severe adverse event: Pancreas: If "Yes", has it been reported?
    boolean
    C0030274 (UMLS CUI [1,1])
    C0700287 (UMLS CUI [1,2])
    Thrombosis
    Item
    Severe adverse event: Thrombosis
    boolean
    C0040053 (UMLS CUI [1])
    Thrombosis: reporting
    Item
    Severe adverse event: Thrombosis: If "Yes", has it been reported?
    boolean
    C0040053 (UMLS CUI [1,1])
    C0700287 (UMLS CUI [1,2])
    Liver
    Item
    Severe adverse event: Liver
    boolean
    C0023884 (UMLS CUI [1])
    Liver: reporting
    Item
    Severe adverse event: Liver: If "Yes", has it been reported?
    boolean
    C0023884 (UMLS CUI [1,1])
    C0700287 (UMLS CUI [1,2])
    Neurologic/ Psychologic aspects
    Item
    Severe adverse event: Neurologic/ Psychologic aspects
    boolean
    C0027763 (UMLS CUI [1])
    C0205486 (UMLS CUI [2])
    Neurologic/ Psychologic aspects: reporting
    Item
    Severe adverse event: Neurologic/ Psychologic aspects: If "Yes", has it been reported?
    boolean
    C0027763 (UMLS CUI [1,1])
    C0700287 (UMLS CUI [1,2])
    C0205486 (UMLS CUI [2,1])
    C0700287 (UMLS CUI [2,2])
    Gastrointestinal aspects
    Item
    Severe adverse event: Gastrointestinal aspects
    boolean
    C0012240 (UMLS CUI [1])
    Gastrointestinal aspects: reporting
    Item
    Severe adverse event: Gastrointestinal aspects: If "Yes", has it been reported?
    boolean
    C0012240 (UMLS CUI [1,1])
    C0700287 (UMLS CUI [1,2])
    Dermatologic aspects
    Item
    Severe adverse event: Dermatologic aspects
    boolean
    C0037274 (UMLS CUI [1])
    Dermatologic aspects: reporting
    Item
    Severe adverse event: Dermatologic aspects: If "Yes", has it been reported?
    boolean
    C0037274 (UMLS CUI [1,1])
    C0700287 (UMLS CUI [1,2])
    Cardiac aspects
    Item
    Severe adverse event: Cardiac aspects
    boolean
    C1522601 (UMLS CUI [1])
    Cardiac aspects: reporting
    Item
    Severe adverse event: Cardiac aspects: If "Yes", has it been reported?
    boolean
    C1522601 (UMLS CUI [1,1])
    C0700287 (UMLS CUI [1,2])
    Renal aspects
    Item
    Severe adverse event: Renal aspects
    boolean
    C0022646 (UMLS CUI [1])
    Renal aspects: reporting
    Item
    Severe adverse event: Renal aspects: If "Yes", has it been reported?
    boolean
    C0022646 (UMLS CUI [1,1])
    C0700287 (UMLS CUI [1,2])
    Metabolic/ endocrinologic aspects
    Item
    Severe adverse event: Metabolic/ endocrinologic aspects
    boolean
    C0025517 (UMLS CUI [1])
    C0694557 (UMLS CUI [2])
    Metabolic/ endocrinologic aspects: reporting
    Item
    Severe adverse event: Metabolic/ endocrinologic aspects: If "Yes", has it been reported?
    boolean
    C0025517 (UMLS CUI [1,1])
    C0700287 (UMLS CUI [1,2])
    C0694557 (UMLS CUI [2,1])
    C0700287 (UMLS CUI [2,2])
    Drug intolerance
    Item
    Severe adverse event: Drug intolerance
    boolean
    C0277585 (UMLS CUI [1])
    Drug intolerance: reporting
    Item
    Severe adverse event: Drug intolerance: If "Yes", has it been reported?
    boolean
    C0277585 (UMLS CUI [1,1])
    C0700287 (UMLS CUI [1,2])
    Skeleton aspects
    Item
    Severe adverse event: Skeleton aspects
    boolean
    C0816871 (UMLS CUI [1])
    Skeleton aspects: reporting
    Item
    Severe adverse event: Skeleton aspects: If "Yes", has it been reported?
    boolean
    C0816871 (UMLS CUI [1,1])
    C0700287 (UMLS CUI [1,2])
    Not classified aspects
    Item
    Severe adverse event: Not classified aspects
    boolean
    C0205426 (UMLS CUI [1])
    Not classified aspects: reporting
    Item
    Severe adverse event: Not classified aspects: If "Yes", has it been reported?
    boolean
    C0205426 (UMLS CUI [1,1])
    C0700287 (UMLS CUI [1,2])
    Item Group
    Identification and Signature
    C0205396 (UMLS CUI-1)
    C1519316 (UMLS CUI-2)
    Date of report
    Item
    Date of report
    date
    C1302584 (UMLS CUI [1])
    Doctor's name
    Item
    Docotor's name
    text
    C0027365 (UMLS CUI [1,1])
    C0031831 (UMLS CUI [1,2])
    Doctor's signature
    Item
    Doctor's signature
    text
    C1519316 (UMLS CUI [1])

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