National Data Archive
Data Catalog
  • Home
  • Microdata Catalog
  • Citations
  • Login
    Login
    Home / Central Data Catalog / FRESH-PEF74115-EN
central

A cohort study of patients with advanced, unresectable (stage IIIB) metastatic (stage IV) non-squamous non-small cell lung cancer (NSCLC) or in relapse starting treatment with Avastin® in combination with chemotherapy as first line treatment of metastatic

France, 2011 - 2013
Reference ID
FRESH-PEF74115-en
Metadata
DDI/XML JSON
Created on
Nov 15, 2025
Last modified
Nov 15, 2025
Page views
4
  • Study Description
  • Get Microdata
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Study authorization
  • Sampling
  • Survey instrument
  • Data collection
  • Study activities
  • Quality standards
  • Data Access
  • Contacts
  • Metadata production
  • Identification

    Survey ID number

    FRESH-PEF74115-en

    Title

    A cohort study of patients with advanced, unresectable (stage IIIB) metastatic (stage IV) non-squamous non-small cell lung cancer (NSCLC) or in relapse starting treatment with Avastin® in combination with chemotherapy as first line treatment of metastatic disease

    Abbreviation or Acronym

    EOLE

    Country
    Name
    France
    Abstract

    This observational study will evaluate modality, efficacy and safety of Avastin (bevacizumab) as first-line treatment in combination with chemotherapy in patients with inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer in clinical practice 1. To describe characteristics of patients treated with Avastin®: demographic and clinical characteristics, history of the disease, and previous disorders and conditions, 2. To describe methods of use of Avastin® in follow-up: doses and durations of treatment with Avastin® (number of cycles); chemotherapy treatments used in combination with treatment with Avastin®; discontinuation of treatment with Avastin® (temporary and permanent) and reasons; treatment strategies set up after discontinuation of treatment with Avastin®, 3. To describe overall survival of patients treated with Avastin®, 4. To describe the safety profile of treatment with Avastin®: serious and non-serious adverse events and targeted adverse events, 5. To describe quality of life: Spitzer's quality of life questionnaire, 6. To describe therapeutic management of patients with non-squamous cell NSCLC in first-line chemotherapy of metastatic disease not receiving Avastin®: compilation of an anonymous registry over a 3-month period starting with time of scientific set up by the investigator.

    Kind of Data

    ['Clinical data']

    Unit of Analysis

    Individuals

    Scope

    Topics
    Topic Vocabulary URI
    Oncology health theme
    cim-11 http://id.who.int/icd/entity/1331250723
    Healthcare system determinants: Use of care health determinant
    Healthcare system determinants health determinant
    Keywords
    Bevacizumab

    Coverage

    Universe

    {
    "level_sex_clusion_I": [
    "Male",
    "Female"
    ],
    "level_age_clusion_I": [
    "Young Adult (19 to 24 years)",
    "Adult (25 to 44 years)",
    "Middle Aged (45 to 64 years)",
    "Aged (65 to 79 years)",
    "Aged, 80 and over (80 years and more)"
    ],
    "level_type_clusion_I": [
    "Patients population"
    ],
    "level_type_clusion_other": "",
    "clusion_I": "",
    "clusion_E": ""
    }

    Producers and sponsors

    Producers
    Name Role
    F. HOFFMANN-LA ROCHE AG sponsor

    Study authorization

    Agency
    Agency name
    Autre

    Sampling

    Sample frame

    Unit Type

    ['Through organizations (health services or institutions, schools, businesses, etc.)']

    Sampling Procedure

    ['Other']

    Survey instrument

    Questionnaires

    Access on specific project only

    Methodology notes

    Observational Study

    Data collection

    Dates of Data Collection
    Start End
    2011 2013
    Time Method

    Longitudinal or cohort study

    Mode of data collection
    • Converting or copying information into a structured record
    • Interview with the participant (including clinical)

    Study activities

    Study activities
    Study activities
    Type
    primary evaluation
    Description
    Health event/morbidity Health event/mortality

    Quality standards

    Other quality statement

    GCP/GVP

    Data Access

    Availability Status

    Restricted access

    Contacts

    Contacts
    Name Email
    Medical data center data_sharing.france@roche.com

    Metadata production

    DDI Document ID

    FRESH-PEF74115-en

    Back to Catalog
    National Data Archive

    © National Data Archive, All Rights Reserved.