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Clinical trial

Global Insights Into Therapeutic Radiopharmaceuticals Safety: A Comprehensive Analysis From the WHO Pharmacovigilance Database (RADIANTS)

ID
Name
20240531
Description
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.
Trial arms
Trial start
2024-05-30
Estimated PCD
2024-08-01
Trial end
2024-08-01
Status
Active (not recruiting)
Treatment
Radiopharmaceuticals drugs
radiopharmaceuticals drugs included in the Anatomical Therapeutic Chemical (ATC) classification system.
Arms:
Adverse Events with Radiopharmaceuticals drugs
Size
500000
Primary endpoint
Toxicity of Radiopharmaceuticals drugs
Case reported in the World Health Organization (WHO) of individual safety case reports through study completion, an average 5 years
Eligibility criteria
Inclusion Criteria: * cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) Exclusion Criteria: * not related to radiopharmaceuticals
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 500000, 'type': 'ESTIMATED'}}
Updated at
2024-07-02

1 organization

1 product

2 indications

Organization
University Hospital
Product
Radiopharmaceuticals
Indication
Cancer
Indication
Adverse Drug Reaction