Monitoring the Antiphospholipid Syndrome:TOXicity of Drugs (APSTOX)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2,700
- Locations
- 1
- Primary Endpoint
- Immune toxicities (such as Antiphospholipid Syndrome) of drugs Identification and report of immune toxicities associated with drugs.
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Immune toxicity induced by drugs and chemotherapies
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
Intervention: Drug inducing antiphospholipid syndrome (Drug)
Outcomes
Primary Outcomes
Immune toxicities (such as Antiphospholipid Syndrome) of drugs Identification and report of immune toxicities associated with drugs.
Time Frame: 01/06/2019
Case reported in the World Health Organization (WHO) database of individual safety case reports
Secondary Outcomes
- 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)
Investigators
Joe Elie Salem
Assistant director, clinical investigation center Paris Est
Groupe Hospitalier Pitie-Salpetriere