Monitoring the Antiphospholipid Syndrome:TOXicity of Drugs (APSTOX)

Adverse Drug Event Clinical Trial

— APSTOX  

Official title:

Monitoring the Antiphospholipid Syndrome:TOXicity of Drugs (APSTOX)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03994302
• Other study ID #: CIC1421-19-10
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: April 8, 2023

Study information

• Verified date: April 2023
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2700
• Est. completion date: April 8, 2023
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adverse Drug Event
• Antiphospholipid Syndrome
• Drug Toxicity
• Drug-Related Side Effects and Adverse Reactions
• Immune Disease
• Immune System Diseases
• Syndrome

Intervention

Drug:
• Drug inducing antiphospholipid syndrome
Drugs susceptible to induce immune toxicities such as antiphospholipid syndrome

Locations

Country	Name	City	State
France	AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune toxicities (such as Antiphospholipid Syndrome) of drugs Identification and report of immune toxicities associated with drugs.	Case reported in the World Health Organization (WHO) database of individual safety case reports	01/06/2019
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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