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R-SEMO: Responsible Side Effects Management in Oncology

Sponsor
University Hospital "Sestre Milosrdnice" (Other)
Overall Status
Completed
CT.gov ID
NCT04623437
Collaborator
(none)
267
Enrollment
1
Location
2.2
Actual Duration (Months)
123.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study of pharmacovigilance in oncology. Monitoring and management of AEs during antineoplastic treatment.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Monitoring and management of AE's during antineoplastic treatment. Comparison of AE's reported by patient with the ones recognised by the oncologist, and vice versa, during antineoplastic treatment.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    267 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comprehensive Antineoplastic Therapy Adverse Events Monitoring and Report
    Actual Study Start Date :
    Jul 1, 2017
    Actual Primary Completion Date :
    Sep 5, 2017
    Actual Study Completion Date :
    Sep 5, 2017

    Outcome Measures

    Primary Outcome Measures

    1. comparison of perspectives [may 2016 until october 2016]

      comparison between patient's and oncologist's perspective on severity of AE's during antineoplastic treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    all cancer patients receiving systemic antineoplastic treatment, ECOG 0-2

    Exclusion Criteria:

    age <18, >75; other active and severe comorbidities; no solid cancer; IUC patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UHC Sestre milorsdnice Zagreb Croatia, Europe Croatia 10 000

    Sponsors and Collaborators

    • University Hospital "Sestre Milosrdnice"

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Robert Šeparović, PhD MD, University Hospital "Sestre Milosrdnice"
    ClinicalTrials.gov Identifier:
    NCT04623437
    Other Study ID Numbers:
    • 2312201522122016
    First Posted:
    Nov 10, 2020
    Last Update Posted:
    Nov 10, 2020
    Last Verified:
    Nov 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Robert Šeparović, PhD MD, University Hospital "Sestre Milosrdnice"
    pharmacovigilance in oncology
    antineoplastic treatment
    adverse events
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Nov 10, 2020