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ID

10878

Description

CWS-2007-HR: A randomised phase-III trial of the Cooperative Soft-Tissue-Study-Group for localised high-risk rhabdomyosarcoma and localised Rhabdomyosarcoma-like Soft Tissue Sarcoma in children, adolescents, and young adults http://clinicaltrials.gov/show/NCT00876031 http://www.cws.olgahospital-stuttgart.de

Link

http://clinicaltrials.gov/show/NCT00876031

Keywords

Versions (2)
  1. 6/8/14 6/8/14 - Martin Dugas
  2. 11/6/15 11/6/15 - Martin Dugas
Uploaded on

11 de junio de 2015

DOI

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License

Creative Commons BY 4.0
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    Rhabdomyosarcoma treatment CWS-2007-HR DRKS00003774 NCT00876031

    German English

    Treatment B4 - Block 4 O-TE Rhabdomyosarcoma NCT00876031

    1 forms  
    Block O-TE
    Description

    Block O-TE

    Start date
    Description

    Datum Beginn

    Data type

    date

    Trofosfamide cumulative dose/course
    Description

    Trofosfamide kumulativ/Block

    Data type

    float

    Measurement units
    • mg
    mg
    Etoposide cumulative dose /course
    Description

    Etoposide kumulativ/Block

    Data type

    float

    Measurement units
    • mg
    mg
    Trofosfamide target value (BSA based)
    Description

    Sollwert Trofosfamid

    Data type

    float

    Measurement units
    • mg
    mg
    Etoposide target value (BSA based)
    Description

    Sollwert Etoposide

    Data type

    float

    Measurement units
    • mg
    mg
    Difference prepreceding block [days]
    Description

    Abstand Blöcke in Tagen

    Data type

    integer

    Toxicity common
    Description

    Toxicity common

    Karnofsky/Lansky index
    Description

    Karnofsky/Lansky Index

    Data type

    integer

    Toxicity hematology
    Description

    Toxicity hematology

    Alias
    UMLS CUI-1
    C0474523
    UMLS CUI-2
    C0040539
    Hemoglobin
    Description

    Hemoglobin toxicity

    Data type

    integer

    Alias
    UMLS CUI-1
    C0019046
    UMLS CUI-2
    C0040539
    Leukocytes (10E9/l)
    Description

    Leukozyten (10E9/l)

    Data type

    integer

    Neutrophils Granulocytes
    Description

    Neutrophile Granulozyten

    Data type

    integer

    Platelets (G/l)
    Description

    Thrombozyten (G/l)

    Data type

    integer

    Toxicity infection
    Description

    Toxicity infection

    Infection
    Description

    Infektion

    Data type

    integer

    Fever (degree C)
    Description

    Fieber ( Grad C)

    Data type

    integer

    Toxicity gastrointestinal
    Description

    Toxicity gastrointestinal

    Nausea
    Description

    Übelkeit

    Data type

    integer

    Vomiting [episodes/24h]
    Description

    Erbrechen [Episoden/24 Std]

    Data type

    integer

    Mucositis/stomatitis (clinical examination)
    Description

    Mucositis (klinisch)

    Data type

    integer

    Diarrhea
    Description

    Diarrhoe

    Data type

    integer

    Toxicity kidney
    Description

    Toxicity kidney

    Creatinine
    Description

    Kreatinin

    Data type

    integer

    Proterinuria (g/24 hrs)
    Description

    Proteinurie (g/24 Std.)

    Data type

    integer

    Hematuria/Hemoglobinuria
    Description

    Hämaturie/Hämoglobinurie

    Data type

    integer

    Toxicity neurology
    Description

    Toxicity neurology

    Confusion
    Description

    Verwirrtheit

    Data type

    integer

    Neuropathy sensory
    Description

    Neuropathie sensorisch

    Data type

    integer

    Neuropathy motor
    Description

    Neuropathie motorisch

    Data type

    integer

    Toxicity liver
    Description

    Toxicity liver

    Bilirubin
    Description

    Bilirubin

    Data type

    integer

    S-GOT/S-GPT
    Description

    S-GOT/S-GPT

    Data type

    integer

    Toxicity Herz
    Description

    Toxicity Herz

    Arrhytmia
    Description

    Arrhytmie

    Data type

    integer

    Left ventricular systolic dysfunction
    Description

    Linksventrikuläre Herzfunktion

    Data type

    integer

    Toxicity other
    Description

    Toxicity other

    Other toxicity specified
    Description

    Bezeichnung andere Toxizität

    Data type

    text

    Toxicity grade
    Description

    Toxicity grade

    Data type

    integer

    Alias
    UMLS CUI-1
    C2826262
    Toxicity comment
    Description

    Toxicity comment

    Comments about toxicity
    Description

    Bemerkungen zur Toxizität

    Data type

    text

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    Similar models

    Treatment B4 - Block 4 O-TE Rhabdomyosarcoma NCT00876031

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Datum Beginn
    Item
    Start date
    date
    Trofosfamide kumulativ/Block
    Item
    Trofosfamide cumulative dose/course
    float
    Etoposide kumulativ/Block
    Item
    Etoposide cumulative dose /course
    float
    Sollwert Trofosfamid
    Item
    Trofosfamide target value (BSA based)
    float
    Sollwert Etoposide
    Item
    Etoposide target value (BSA based)
    float
    Abstand Blöcke in Tagen
    Item
    Difference prepreceding block [days]
    integer
    Item
    Karnofsky/Lansky index
    integer
    Karnofsky- Lansky Index in 5 Stufen
    Code List
    Karnofsky/Lansky index
    CL Item
    100% (100)
    CL Item
    90% (90)
    CL Item
    80% (80)
    CL Item
    70% (70)
    CL Item
    60% (60)
    CL Item
    50% (50)
    CL Item
    40% (40)
    CL Item
    30% (30)
    CL Item
    20% (20)
    CL Item
    10% (10)
    CL Item
    Death (0)
    Item Group
    C0474523 (UMLS CUI-1)
    C0040539 (UMLS CUI-2)
    Item
    Hemoglobin
    integer
    C0019046 (UMLS CUI-1)
    C0040539 (UMLS CUI-2)
    Toxicity grade
    Code List
    Hemoglobin
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    Leukocytes (10E9/l)
    integer
    Toxicity grade
    Code List
    Leukocytes (10E9/l)
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    Neutrophils Granulocytes
    integer
    Toxicity grade
    Code List
    Neutrophils Granulocytes
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    Platelets (G/l)
    integer
    Toxicity grade
    Code List
    Platelets (G/l)
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    Infection
    integer
    Toxicity grade
    Code List
    Infection
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    Fever (degree C)
    integer
    Toxicity grade
    Code List
    Fever (degree C)
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    Nausea
    integer
    Toxicity grade
    Code List
    Nausea
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    Vomiting [episodes/24h]
    integer
    Toxicity grade
    Code List
    Vomiting [episodes/24h]
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    Mucositis/stomatitis (clinical examination)
    integer
    Toxicity grade
    Code List
    Mucositis/stomatitis (clinical examination)
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    Diarrhea
    integer
    Toxicity grade
    Code List
    Diarrhea
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    Creatinine
    integer
    Toxicity grade
    Code List
    Creatinine
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    Proterinuria (g/24 hrs)
    integer
    Toxicity grade
    Code List
    Proterinuria (g/24 hrs)
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    Hematuria/Hemoglobinuria
    integer
    Toxicity grade
    Code List
    Hematuria/Hemoglobinuria
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    Confusion
    integer
    Toxicity grade
    Code List
    Confusion
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    Neuropathy sensory
    integer
    Toxicity grade
    Code List
    Neuropathy sensory
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    Neuropathy motor
    integer
    Toxicity grade
    Code List
    Neuropathy motor
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item Group
    Item
    Bilirubin
    integer
    Toxicity grade
    Code List
    Bilirubin
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    S-GOT/S-GPT
    integer
    Toxicity grade
    Code List
    S-GOT/S-GPT
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item Group
    Item
    Arrhytmia
    integer
    Toxicity grade
    Code List
    Arrhytmia
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item
    Left ventricular systolic dysfunction
    integer
    Toxicity grade
    Code List
    Left ventricular systolic dysfunction
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Item Group
    Bezeichnung andere Toxizität
    Item
    Other toxicity specified
    text
    Item
    Toxicity grade
    integer
    C2826262 (UMLS CUI-1)
    Toxicity grade
    Code List
    Toxicity grade
    CL Item
    Grade 0 (0)
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    Bemerkungen zur Toxizität
    Item
    Comments about toxicity
    text
    Back to the top of the page 

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