Radiopharmaceuticals Analysis for Detailed Insights And INternational Tracking of Safety

Active, not recruiting

• Conditions: Cancer; Side Effect of Drug
• Interventions: Drug: Radiopharmaceuticals drugs

• Registration Number: NCT06483685
• Lead Sponsor: University Hospital, Caen

Brief Summary

Little is known about cancer therapy-related radiopharmaceuticals drugs safety. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, to identify and describe cases of cancer therapy-related radiopharmaceuticals drugs.

Detailed Description

Radiopharmaceuticals drugs especially for therapeutic purposes are responsible of a wide range of side effects. The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of adverse drug reactions following treatment with radiopharmaceuticals drugs.

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-30
• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-25
• Last Update Submitted: 2024-06-25
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500000

Inclusion Criteria

• cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase)

Exclusion Criteria

• not related to radiopharmaceuticals

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adverse Events with Radiopharmaceuticals drugs	Radiopharmaceuticals drugs	Cases reported in the World Health Organization (WHO) of patients treated by Radiopharmaceuticals drugs with reported toxicity

Primary Outcome Measures

Name	Time	Method
Toxicity of Radiopharmaceuticals drugs	Case reported in the World Health Organization (WHO) of individual safety case reports through study completion, an average 5 years	Identification and report of toxicities of radiopharmaceuticals drugs. The research includes the report with MedDRA terms: System organ class (SOC), Preferred terms (PT), High level group term (HLGT), High level term (HLT)

Secondary Outcome Measures

Name	Time	Method
Individual safety case reports parameters	Through study completion, an average 5 years	weight in kilograms, height in meters, age in years, country, date of report in years, co-medication in active ingredients name, sex (male / female), severity (yes or no), death reported (yes or no), reporter qualification, action taken with drug, outcome (recovered, not recovered, role of co-medication (suspect, concomittant, unknown), drugs doses (MegaBecquerels, milligrams, grams, international units, milliliters), route of administration. Date of suspected drug administration, Start date and end date of reported adverse events. Dechallenge of suspected drugs (yes , no, unknown), Rechallenge of suspected drugs (yes , no, unknown).

Trial Locations

Locations (1)

Caen Normandy University Hospital; 🇫🇷 Caen, Normandy, France