Monitoring the Antiphospholipid Syndrome:TOXicity of Drugs (APSTOX)

Groupe Hospitalier Pitie-Salpetriere

Status: Completed

Conditions: Adverse Drug Event; Antiphospholipid Syndrome; Immune Disease; Drug Toxicity

Treatments: Drug: Drug inducing antiphospholipid syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT03994302

CIC1421-19-10

Details and patient eligibility

About

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).

Full description

Several drugs and chemotherapies seem to have an impact on the immune system and are responsible of a wide range of immune side effects such as antiphospholipid syndrome. Those are poorly described, due to the modificationof the pharmacopeia, and the recent recognition of several of these adverseevents.

This study investigates the main characteristics of patients affected by immune side effects imputed to drugs in particular antiphospholipid syndrome.

A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Enrollment: 2,700 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,700 participants in 1 patient group

Immune toxicity induced by drugs and chemotherapies

Description:

Immune toxicity induced by drugs and chemotherapies Case reported in the World Health Organization (WHO) of immune toxicities(such as Antiphospholipid syndrome) of patient treated by a drug, with a chronology compatible with the drug toxicity

Treatment:

Drug: Drug inducing antiphospholipid syndrome