Radiopharmaceuticals Analysis for Detailed Insights And INternational Tracking of Safety

N/AActive Not RecruitingNCT06483685

University Hospital, Caen500,000 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

500,000

Conditions

Cancer Side Effect of Drug

Interventions

Radiopharmaceuticals drugsDRUG

radiopharmaceuticals drugs included in the Anatomical Therapeutic Chemical (ATC) classification system.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) Exclusion Criteria: * not related to radiopharmaceuticals

Locations (1)

Caen Normandy University Hospital

Caen, Normandy, France

Outcomes

Primary Outcomes

Toxicity of Radiopharmaceuticals drugs

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)

Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports through study completion, an average 5 years

Secondary Outcomes

Individual safety case reports parameters

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).

Time frame: Through study completion, an average 5 years

Data from ClinicalTrials.gov

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