Responsible Side Effects Management in Oncology

Comprehensive Antineoplastic Therapy Adverse Events Monitoring and Report

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04623437

Acronym

R-SEMO

Enrollment

267

Registered

2020-11-10

Start date

2017-07-01

Completion date

2017-09-05

Last updated

2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antineoplastic Treatment, Oncology, Pharmacovigilance

Keywords

pharmacovigilance in oncology, antineoplastic treatment, adverse events

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Croatia

Outcome results