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| ID | Type | Description | Link |
|---|---|---|---|
| RADIANTS | Other Identifier | University Hospital Caen |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adverse Events with Radiopharmaceuticals drugs | Cases reported in the World Health Organization (WHO) of patients treated by Radiopharmaceuticals drugs with reported toxicity |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiopharmaceuticals drugs | Drug | radiopharmaceuticals drugs included in the Anatomical Therapeutic Chemical (ATC) classification system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Case reported in the World Health Organization (WHO) of individual safety case reports through study completion, an average 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) related to radiopharmaceuticals
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Vigne, PharmD, PhD | CHU de Caen Normandie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caen Normandy University Hospital | Caen | Normandy | 14033 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34057232 | Background | Dolladille C, Ederhy S, Ezine E, Choquet S, Nguyen LS, Alexandre J, Moslehi JJ, Dechartres A, Salem JE. Chimeric antigen receptor T-cells safety: A pharmacovigilance and meta-analysis study. Am J Hematol. 2021 Sep 1;96(9):1101-1111. doi: 10.1002/ajh.26259. Epub 2021 Jun 23. | |
| 37111725 | Background | Ladriere T, Faudemer J, Levigoureux E, Peyronnet D, Desmonts C, Vigne J. Safety and Therapeutic Optimization of Lutetium-177 Based Radiopharmaceuticals. Pharmaceutics. 2023 Apr 13;15(4):1240. doi: 10.3390/pharmaceutics15041240. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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| Through study completion, an average 5 years |
| 35513605 | Result | Vigne J, Chretien B, Bignon AL, Bouhier-Leporrier K, Dolladille C. [177Lu]Lu-DOTATATE peptide receptor radionuclide therapy-associated myeloid neoplasms: insights from the WHO pharmacovigilance database. Eur J Nucl Med Mol Imaging. 2022 Aug;49(10):3332-3333. doi: 10.1007/s00259-022-05833-6. Epub 2022 May 6. No abstract available. |