Cancer, Side Effect of Drug
Conditions
Keywords
Pharmacovigilance, Adverse Drug Reactions, Nuclear Medicine, Radiotherapeutics
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.
Interventions
DRUGRadiopharmaceuticals drugs
radiopharmaceuticals drugs included in the Anatomical Therapeutic Chemical (ATC) classification system.
Sponsors
University Hospital, Caen
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase)
Exclusion criteria
* not related to radiopharmaceuticals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
France
Outcome results
None listed