Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Monitoring the Antiphospholipid Syndrome:TOXicity of Drugs (APSTOX)

ID
Name
CIC1421-19-10
Description
Several drugs and chemotherapies seem to have an impact on the immune system. This study investigates reports of immune toxicities such as antiphospholipid syndrome, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).
Trial arms
Trial start
2019-06-01
Estimated PCD
2021-06-30
Trial end
2023-04-08
Status
Completed
Treatment
Drug inducing antiphospholipid syndrome
Drugs susceptible to induce immune toxicities such as antiphospholipid syndrome
Arms:
Immune toxicity induced by drugs and chemotherapies
Size
2700
Primary endpoint
Immune toxicities (such as Antiphospholipid Syndrome) of drugs Identification and report of immune toxicities associated with drugs.
01/06/2019
Eligibility criteria
Inclusion Criteria: - Case reported in the WHO's pharmacovigilance database till 01/06/2019 Exclusion Criteria: * Chronology not compatible between the drug and the toxicity
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '1 Year', 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'count': 2700, 'type': 'ACTUAL'}}
Updated at
2023-04-13

1 organization

1 product

4 indications

Organization
Groupe Hospitalier Pitie-Salpetriere
Product
Drug inducing antiphospholipid syndrome
Indication
Antiphospholipid Syndrome
Indication
Immune system disorder
Indication
Adverse Drug Event
Indication
Drug Toxicity