Monitoring the Antiphospholipid Syndrome:TOXicity of Drugs (APSTOX)

Completed

• Conditions: Antiphospholipid Syndrome; Immune Disease; Adverse Drug Event; Drug Toxicity
• Interventions: Drug: Drug inducing antiphospholipid syndrome

• Registration Number: NCT03994302
• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2019-06-19
• Study First Submitted QC: 2019-06-19
• Study First Posted: 2019-06-21
• Primary Completion: 2021-06-30
• Status Verified: 2023-04
• Study Completion: 2023-04-08
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Immune toxicity induced by drugs and chemotherapies	Drug inducing antiphospholipid syndrome	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

Primary Outcome Measures

Name	Time	Method
Immune toxicities (such as Antiphospholipid Syndrome) of drugs Identification and report of immune toxicities associated with drugs.	01/06/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports

Secondary Outcome Measures

Name	Time	Method
Causality assessment of reported metabolic toxicities events according to the WHO system Case reported in the World Health Organization (WHO) database of individual safety case reports	01/06/2019
Description of the type of immune toxicity depending on the category of drug Case reported in the World Health Organization (WHO) database of individual safety case reports	01/06/2019
Description of the other immune related adverse events concomitant to the immune toxicity induced by drugs Case reported in the World Health Organization (WHO) database of individual safety case reports	01/06/2019
Description of the duration of treatment when the toxicity happens (role of cumulative dose) Case reported in the World Health Organization (WHO) database of individual safety case reports	01/06/2019
Description of the drug-drug interactions associated with adverse events Case reported in the World Health Organization (WHO) database of individual safety case reports	01/06/2019
Description of the pathologies (cancer) for which the incriminated drugs have been prescribed Case reported in the World Health Organization (WHO) database of individual safety case reports	01/06/2019
Description of the population of patients having hematological toxicity adverse event Case reported in the World Health Organization (WHO) database of individual safety case reports	01/06/2019

Trial Locations

Locations (1)

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM; 🇫🇷 Paris, France