0 Bewertungen

ID

41510

Beschreibung

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

Stichworte

  1. 14.09.20 14.09.20 -
  2. 30.10.20 30.10.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

30. Oktober 2020

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Itemgroup Kommentare für :

Item Kommentare für :


    Keine Kommentare

    Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

    Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162

    Radiotherapy; Local Surgery (Report Final and Annex Report 2 Final)

    Administrative
    Beschreibung

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Patient Number
    Beschreibung

    Patient Number

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Radiotherapy
    Beschreibung

    Radiotherapy

    Alias
    UMLS CUI-1
    C1522449
    Has the patient received low-dose radiotherapy during the study treatment period?
    Beschreibung

    If yes → Please record radiotherapy details below.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1522449
    UMLS CUI [1,2]
    C1708745
    UMLS CUI [2,1]
    C0347984
    UMLS CUI [2,2]
    C0008976
    Radiotherapy
    Beschreibung

    Radiotherapy

    Alias
    UMLS CUI-1
    C1522449
    Radiotherapy Site
    Beschreibung

    Radiotherapy Site

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1522449
    UMLS CUI [1,2]
    C1515974
    Other site, specify
    Beschreibung

    Other site, specify

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1515974
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Cumulative dose
    Beschreibung

    Cumulative dose

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C2986497
    Units
    Beschreibung

    Units

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1519795
    Date of first administration
    Beschreibung

    Date of first administration

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C3173309
    Date of last administration
    Beschreibung

    Date of last administration

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C1762893
    UMLS CUI [1,2]
    C1533734
    Status of the lesion before radiotherapy
    Beschreibung

    Status of the lesion before radiotherapy

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0449438
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [2,1]
    C1522449
    UMLS CUI [2,2]
    C0332152
    Type of lesion (Radiotherapy)
    Beschreibung

    Type of lesion (Radiotherapy)

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [2]
    C1522449
    If target lesion, specify number (Radiotherapy)
    Beschreibung

    If target lesion, specify number (Radiotherapy)

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1521840
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [2]
    C2348235
    UMLS CUI [3]
    C0237753
    UMLS CUI [4]
    C1522449
    Local Surgery
    Beschreibung

    Local Surgery

    Alias
    UMLS CUI-1
    C0543467
    UMLS CUI-2
    C0205276
    Have some lesions been resected during the study treatment period?
    Beschreibung

    If Yes, please record surgery details below

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C0728940
    UMLS CUI [2,1]
    C0347984
    UMLS CUI [2,2]
    C0008976
    Local Surgery
    Beschreibung

    Local Surgery

    Alias
    UMLS CUI-1
    C0543467
    UMLS CUI-2
    C0205276
    Surgery Site
    Beschreibung

    Surgery Site

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1515974
    UMLS CUI [1,2]
    C0543467
    Date of surgery
    Beschreibung

    Date of surgery

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C3258210
    Status of the lesion before surgery
    Beschreibung

    Status of the lesion before surgery

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0449438
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [2,1]
    C0543467
    UMLS CUI [2,2]
    C0332152
    Type of lesion (Surgery)
    Beschreibung

    Type of lesion (Surgery)

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [2]
    C0543467
    If target lesion, specify number (Surgery)
    Beschreibung

    If target lesion, specify number (Surgery)

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C1521840
    UMLS CUI [2,1]
    C0237753
    UMLS CUI [2,2]
    C2348235
    UMLS CUI [3]
    C0543467

    Ähnliche Modelle

    Radiotherapy; Local Surgery (Report Final and Annex Report 2 Final)

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Patient Number
    Item
    Patient Number
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Radiotherapy
    C1522449 (UMLS CUI-1)
    Has the patient received low-dose radiotherapy during the study treatment period?
    Item
    Has the patient received low-dose radiotherapy during the study treatment period?
    boolean
    C1522449 (UMLS CUI [1,1])
    C1708745 (UMLS CUI [1,2])
    C0347984 (UMLS CUI [2,1])
    C0008976 (UMLS CUI [2,2])
    Item Group
    Radiotherapy
    C1522449 (UMLS CUI-1)
    Item
    Radiotherapy Site
    integer
    C1522449 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    Code List
    Radiotherapy 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)
    Other site, specify
    Item
    Other site, specify
    text
    C1515974 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Cumulative dose
    Item
    Cumulative dose
    float
    C2986497 (UMLS CUI [1])
    Item
    Units
    text
    C1519795 (UMLS CUI [1])
    Code List
    Units
    CL Item
    Grays  (Gy)
    CL Item
    Centigrays  (cGy)
    CL Item
    x100 Rads (rd)
    Date of first administration
    Item
    Date of first administration
    date
    C3173309 (UMLS CUI [1])
    Date of last administration
    Item
    Date of last administration
    date
    C1762893 (UMLS CUI [1,1])
    C1533734 (UMLS CUI [1,2])
    Item
    Status of the lesion before radiotherapy
    text
    C0449438 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C1522449 (UMLS CUI [2,1])
    C0332152 (UMLS CUI [2,2])
    Code List
    Status of the lesion before radiotherapy
    CL Item
    Progressive lesion  (PD)
    CL Item
    Stable lesion  (SD)
    CL Item
    Regressive lesion  (Reg)
    CL Item
    New lesion (New)
    Item
    Type of lesion (Radiotherapy)
    text
    C0221198 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1522449 (UMLS CUI [2])
    Code List
    Type of lesion (Radiotherapy)
    CL Item
    Target lesion  (TG)
    CL Item
    Non-Target lesion (NT)
    If target lesion, specify number (Radiotherapy)
    Item
    If target lesion, specify number (Radiotherapy)
    integer
    C1521840 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [2])
    C0237753 (UMLS CUI [3])
    C1522449 (UMLS CUI [4])
    Item Group
    Local Surgery
    C0543467 (UMLS CUI-1)
    C0205276 (UMLS CUI-2)
    Have some lesions been resected during the study treatment period?
    Item
    Have some lesions been resected during the study treatment period?
    boolean
    C0221198 (UMLS CUI [1,1])
    C0728940 (UMLS CUI [1,2])
    C0347984 (UMLS CUI [2,1])
    C0008976 (UMLS CUI [2,2])
    Item Group
    Local Surgery
    C0543467 (UMLS CUI-1)
    C0205276 (UMLS CUI-2)
    Item
    Surgery Site
    integer
    C1515974 (UMLS CUI [1,1])
    C0543467 (UMLS CUI [1,2])
    Code List
    Surgery 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)
    Date of surgery
    Item
    Date of surgery
    date
    C3258210 (UMLS CUI [1])
    Item
    Status of the lesion before surgery
    text
    C0449438 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C0543467 (UMLS CUI [2,1])
    C0332152 (UMLS CUI [2,2])
    Code List
    Status of the lesion before surgery
    CL Item
    Progressive lesion  (PD)
    CL Item
    Stable lesion  (SD)
    CL Item
    Regressive lesion  (Reg)
    CL Item
    New lesion (New)
    Item
    Type of lesion (Surgery)
    text
    C0221198 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C0543467 (UMLS CUI [2])
    Code List
    Type of lesion (Surgery)
    CL Item
    Target lesion  (TG)
    CL Item
    Non-Target lesion (NT)
    If target lesion, specify number (Surgery)
    Item
    If target lesion, specify number (Surgery)
    integer
    C0221198 (UMLS CUI [1,1])
    C1521840 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [2,1])
    C2348235 (UMLS CUI [2,2])
    C0543467 (UMLS CUI [3])

    Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

    Zum Video