Pharmacovigilance Assessment of Reporting of Cardiovascular Adverse Events With Antineoplastic Agents (PARCA) (PARCA)

May 9, 2024 updated by: The First Affiliated Hospital of Xinxiang Medical College
The aim of this observational study is to explore and analyze reports of cardiac or vascular adverse events linked to the administration of antineoplastic agents among patients diagnosed with tumors represented by advanced non-small cell lung cancer. The study leverages pharmacovigilance databases such as the World Health Organization (WHO) database (VigiBase), FDA Adverse Event Reporting System (FAERS), and others to gather individual safety case reports for analysis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Concomitant antineoplastic drug therapy may produce serious adverse cardiac or vascular system events. In this study, reports of cardiovascular adverse drug events following treatment with antineoplastic drugs were investigated using the World Health Organization (WHO) personal safety case report database (VigiBase) and FDA Adverse Event Reporting System (FAERS).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who have been treated with an antineoplastic agent and have been diagnosed with tumors that represent advanced non-small cell lung cancer.

Description

Inclusion Criteria:

  1. Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024.
  2. Adverse events reported were including the MedDRA terms: Cardiac disorders (SOC), Vascular disorders (SOC), Cardiac and vascular investigations (excl enzyme tests) (HLGT), Sudden death (PT), Sudden cardiac death (PT), Cardiac arrhythmias (HLGT), Cardiac disorder signs and symptoms (HLGT), Cardiac neoplasms (HLGT), Cardiac valve disorders (HLGT), Coronary artery disorders (HLGT), Endocardial disorders (HLGT), Heart failures (HLGT), Myocardial disorders (HLGT), Pericardial disorders (HLGT), Vascular disorders NEC(HLGT), Vascular inflammations(HLGT), Embolism and thrombosis(HLGT), Vascular hypertensive disorders(HLGT), Blood pressure disorders NEC(HLGT), Venous varices(HLGT), Arteriosclerosis, stenosis, vascular insufficiency and necrosis(HLGT), Aneurysms and artery dissections(HLGT).
  3. Patients treated with antineoplastic agents (including small-molecule kinase inhibitors, immune checkpoint inhibitors, monoclonal antibodies, cytotoxic drugs, and other therapeutics).
  4. The number of reports corresponding to each drug or adverse event is at least three.
  5. The primary indication is malignant tumors, specifically advanced non-small cell lung cancer.

Exclusion Criteria:

  1. Any of the information in the baseline information such as gender, age, region, date of report is empty.
  2. The severity level of the reported adverse event is empty.
  3. Adverse events were reported in patients whose drug indications included cardiovascular disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Adverse Events with Antineoplastic agents
Cases reported in VigiBase, FAERS and other pharmacovigilance databases of patients treated by antineoplastic agents, with a chronology compatible with the drug toxicity.
Drug: Antineoplastic Agents
small-molecule kinase inhibitors, immune checkpoint inhibitors, monoclonal antibodies, cytotoxic drugs, and other therapeutics

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cardio-vascular toxicity of antineoplastic agents
Time Frame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Identification and report of the cardio-vascular toxicity of antineoplastic agents. The research includes the report with MedDRA terms: SOC Cardiac Disorders, SOC Vascular Disorders, Cardiac and vascular investigations (excl enzyme tests) (HLGT), Skeletal and cardiac muscle analyses (HLT), Sudden death (PT). Drugs investigated are antineoplastic agents.
Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Causality assessment of reported cardiovascular events according to pharmacovigilance databases
Time Frame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Disproportionality individual case data analysis between cardiovascular events and antineoplastic agents.
Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Assessment of the association between cardiovascular toxicity due to antineoplastic agents and risk factors.
Time Frame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Cardiovascular events are identified using MedDRA terms. Each cardiovascular event and risk factor will be assessed for potential over-reporting by calculating odds ratios. Factors evaluated will include, but are not limited to, cancer type and patient baseline characteristics (gender, age, country of reporting, etc.). Additionally, the year of reporting and other relevant variables will be considered.
Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Assess cardiovascular toxicity differences among antineoplastic agent classes and within the same class.
Time Frame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
The data were classified into different drug classes based on the Anatomical Therapeutic Chemical (ATC) classification system. This included small molecule kinase inhibitors, immune checkpoint inhibitors, and monoclonal antibodies. The occurrence of major adverse events was identified using the Medical Dictionary for Regulatory Activities (MedDRA) terminology. The differences in cardiovascular toxicity between drug classes were evaluated using disproportionality analysis (single drug vs. full database). To assess toxicity differences between drugs in the same class, for example, a comparison could be made between the cardiovascular toxicity of drugs such as erlotinib, afatinib, and osimertinib, which all belong to the category of EGFR tyrosine kinase inhibitors. Disproportionality analyses (single drug vs. other drugs in the same class) were employed in this regard.
Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Assessment of the severity of cardiovascular toxicity associated with antineoplastic agents
Time Frame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Reports with fatal outcomes will be compared with reports without fatal outcomes. Odds ratio will be calculated to compare covariates that may be associated with an increased risk of death, including type of adverse cardiovascular event, type of cancer reported, age of the patient, gender, comorbidities, and antitumor monotherapy or combination therapy.
Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Description of the duration of treatment when the toxicity happens (role of cumulative dose)
Time Frame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
The analysis includes analyzing the relationship between the duration of treatment and the occurrence of toxicity, taking into account the cumulative dose of the administered medication.
Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Description of the drug-drug interactions associated with adverse events.
Time Frame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Describe cardiovascular adverse events reported when two or more drugs are taken concurrently or consecutively in patients with the same indication.
Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Description of the population of patients having a cardio-vascular adverse events
Time Frame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
The patient population with cardiovascular adverse events was described in terms of baseline information, including patient indication, age, sex, country of reporting origin, and clinical outcomes, among other factors.
Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital of Xinxiang Medical College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Xiaohong Kang, PhD, First Affiliated Hospital of Xinjiang Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EC-024-092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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