Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409481
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-04-25
Brief Title:
Pharmacovigilance Assessment of Reporting of Cardiovascular Adverse Events With Antineoplastic Agents PARCA
Sponsor:
The First Affiliated Hospital of Xinxiang Medical College
Organization:
The First Affiliated Hospital of Xinxiang Medical College
Study Overview
Official Title:
Pharmacovigilance Assessment of Reporting of Cardiovascular Adverse Events With Antineoplastic Agents PARCA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PARCA
Brief Summary:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None