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NCT04623437 Clinical Trial

Responsible Side Effects Management in Oncology

Oncology Clinical Trial

— R-SEMO  

Official title:
Comprehensive Antineoplastic Therapy Adverse Events Monitoring and Report

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04623437
Other study ID # 2312201522122016
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2017
Est. completion date September 5, 2017

Study information
Verified date November 2020
Source University Hospital "Sestre Milosrdnice"
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 267
Est. completion date September 5, 2017
Est. primary completion date September 5, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Croatia UHC Sestre milorsdnice Zagreb Croatia, Europe

Sponsors (1)
Lead Sponsor Collaborator
University Hospital "Sestre Milosrdnice"

Country where clinical trial is conducted

Croatia, 

Outcome
Type Measure Description Time frame Safety issue
Primary comparison of perspectives comparison between patient's and oncologist's perspective on severity of AE's during antineoplastic treatment may 2016 until october 2016
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