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ID

44476

Description

NCT00180102 AML2003 is a prospective randomized trial, to investigate the value of early allogeneic stem cell transplantation in aplasia after induction therapy for high risk patients with acute myeloid leukemia. Phase 4 Study Type:Interventional Study Design:Allocation: Randomized Intervention Model:Factorial Assignment Masking:None (Open Label) Primary Purpose:Treatment Medical Department I, University Hospital Carl Gustav Carus Dresden, Germany, 01307 Sponsors and Collaborators Technische Universität Dresden Principal Investigator:Gerhard Ehninger, MD University Hospital Carl Gustav Carus Dresden

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Versions (2)
  1. 1/19/18 1/19/18 -
  2. 9/27/21 9/27/21 -
Copyright Holder

Technische Universität Dresden,Dr. Röllig

Uploaded on

September 27, 2021

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Creative Commons BY-NC 3.0
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    AML2003 - Standard-Therapy vs Intensified Therapy for Adult Acute Myeloid Leukemia Patients NCT00180102

    German

    Induktionstherapie -Unerwünschte Ereignisse CTC 3.0-

    25 forms  
    Unerwünschte Ereignisse
    Description

    Unerwünschte Ereignisse

    Alias
    UMLS CUI-1
    C0877248
    Klinik-Nr.:
    Description

    Hospital number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0806432
    Patienten-Nr.:
    Description

    Patient number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Patienten-Initialen:
    Description

    Patient initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
    Ereignis
    Description

    Wenn schwerwiegendes unerwünschtes Ereignis, SUE-Bogen ausfüllen!

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0877248
    Sonstiges
    Description

    Other adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    Sonstiges, bitte spezifizieren
    Description

    Specify other adverse event

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1521902
    Beginn
    Description

    Adverse event start date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2697888
    Ende
    Description

    Adverse event end date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2697886
    Intensität
    Description

    Intensity

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2985921
    Kausalität (mit Studienmedikation)
    Description

    causality

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3641099
    Bestätigung
    Description

    Bestätigung

    Alias
    UMLS CUI-1
    C0750484
    Datum
    Description

    Date of completion

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Name des Studienarztes
    Description

    Investigator name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
    Unterschrift
    Description

    Signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Back to the top of the page

    Similar models

    Induktionstherapie -Unerwünschte Ereignisse CTC 3.0-

    25 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Unerwünschte Ereignisse
    C0877248 (UMLS CUI-1)
    Hospital number
    Item
    Klinik-Nr.:
    integer
    C0806432 (UMLS CUI [1])
    Patient number
    Item
    Patienten-Nr.:
    integer
    C2348585 (UMLS CUI [1])
    Patient initials
    Item
    Patienten-Initialen:
    text
    C2986440 (UMLS CUI [1])
    Item
    Ereignis
    integer
    C0877248 (UMLS CUI [1])
    Advers event
    Code List
    Ereignis
    CL Item
    allergische Reaktion (1)
    (Comment:de)
    CL Item
    Hämoglobin (2)
    (Comment:de)
    CL Item
    Leukozyten (3)
    (Comment:de)
    CL Item
    Neutrophile (4)
    (Comment:de)
    CL Item
    Thrombozyten (5)
    (Comment:de)
    CL Item
    Arrhythmien (6)
    (Comment:de)
    CL Item
    kardiale Ischämie/Myokardinfarkt (7)
    (Comment:de)
    CL Item
    Hypertonie (8)
    (Comment:de)
    CL Item
    Hypotonie (9)
    (Comment:de)
    CL Item
    linksventrik. systolische Dysfunktion (10)
    (Comment:de)
    CL Item
    Perikarditis (11)
    CL Item
    pulmonale Hypertonie (12)
    CL Item
    DIC (13)
    CL Item
    Fibrinogen (14)
    CL Item
    Fieber (Neutrophile > 1,0 GPt/l) (15)
    CL Item
    neutropenisches Fieber > 38,5 °C (Neutrophile < 1,0 GPt/l) (16)
    CL Item
    Ausschlag/Schuppung (17)
    CL Item
    Pankreas endokrin (Glukoseintoleranz) (18)
    CL Item
    Diarrhoe (19)
    CL Item
    Dysphagie/Ösophagitis/Gastritis/Ileus (20)
    CL Item
    Enteritis (21)
    CL Item
    Mukositis/Stomatitis (22)
    CL Item
    Übelkeit/Erbrechen (23)
    CL Item
    Blutung (24)
    CL Item
    Pankreatitis (25)
    CL Item
    Infektion (26)
    CL Item
    Alkalische Phosphatase (27)
    CL Item
    ALAT, GPT (28)
    CL Item
    ASAT, GOT (29)
    CL Item
    Bilirubin (30)
    CL Item
    Kreatinin (31)
    CL Item
    GGT (32)
    CL Item
    Ataxie (33)
    CL Item
    motorische Neuropathie (34)
    CL Item
    sensorische Neuropathie (35)
    CL Item
    Krampfanfälle (36)
    CL Item
    Nystagmus (37)
    CL Item
    Augenerkrankung (38)
    CL Item
    Schmerzen (39)
    CL Item
    Dyspnoe (40)
    CL Item
    Hypoxie (41)
    CL Item
    Pleuraerguss - ohne maligne Genese (42)
    CL Item
    Pneumonitis/Lungeninfiltrate (43)
    CL Item
    Zystitis (44)
    CL Item
    Tumorlyse-Syndrom (45)
    CL Item
    Thrombose/Embolie (46)
    Other adverse event
    Item
    Sonstiges
    boolean
    C0877248 (UMLS CUI [1])
    Specify other adverse event
    Item
    Sonstiges, bitte spezifizieren
    text
    C0877248 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    Adverse event start date
    Item
    Beginn
    date
    C2697888 (UMLS CUI [1])
    Adverse event end date
    Item
    Ende
    date
    C2697886 (UMLS CUI [1])
    Item
    Intensität
    integer
    C2985921 (UMLS CUI [1])
    Intensity
    Code List
    Intensität
    CL Item
    leicht (1)
    CL Item
    mäßig (2)
    CL Item
    schwer (3)
    CL Item
    lebensbedrohlich (4)
    Item
    Kausalität (mit Studienmedikation)
    integer
    C3641099 (UMLS CUI [1])
    causality
    Code List
    Kausalität (mit Studienmedikation)
    CL Item
    unbekannt (0)
    CL Item
    nein (1)
    CL Item
    möglich (2)
    CL Item
    ja (sicher) (3)
    Item Group
    Bestätigung
    C0750484 (UMLS CUI-1)
    Date of completion
    Item
    Datum
    date
    C0011008 (UMLS CUI [1])
    Investigator name
    Item
    Name des Studienarztes
    text
    C2826892 (UMLS CUI [1])
    Signature
    Item
    Unterschrift
    text
    C2346576 (UMLS CUI [1])
    Back to the top of the page 

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