Responsible Side Effects Management in Oncology

Completed

• Conditions: Oncology; Antineoplastic Treatment; Pharmacovigilance

• Registration Number: NCT04623437
• Lead Sponsor: University Hospital "Sestre Milosrdnice"

Brief Summary

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

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 Timeline

• Study Start: 2017-07-01
• Primary Completion: 2017-09-05
• Study Completion: 2017-09-05
• Status Verified: 2020-11
• Study First Submitted: 2020-11-04
• Study First Submitted QC: 2020-11-04
• Last Update Submitted: 2020-11-04
• Study First Posted: 2020-11-10
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
comparison of perspectives	may 2016 until october 2016	comparison between patient's and oncologist's perspective on severity of AE's during antineoplastic treatment

Trial Locations

Locations (1)

UHC Sestre milorsdnice; 🇭🇷 Zagreb, Croatia, Europe, Croatia