An observational study in Antiphospholipid Syndrome, Immune Disease and Adverse Drug Event, sponsored by Groupe Hospitalier Pitie-Salpetriere. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-13.
Sponsored by Groupe Hospitalier Pitie-Salpetriere · Observational
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).
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.
121 studies on the registry are indexed under Antiphospholipid Syndrome; 51 are open to participants now.
This study's enrollment of 2,700 is above the median of 181 across 52 observational studies indexed under Antiphospholipid Syndrome.
Browse Antiphospholipid Syndrome studies →Groupe Hospitalier Pitie-Salpetriere is the lead sponsor of 65 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients treated with a drug that could be reported in the WHO's pharmacovigilance database
Exclusion Criteria:
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
Drug: Drug inducing antiphospholipid syndrome
Drugs susceptible to induce immune toxicities such as antiphospholipid syndrome
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
Time frame: 01/06/2019
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 01/06/2019
Plan to share: Undecided
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Groupe Hospitalier Pitie-Salpetriere