Adverse Drug Event Clinical Trial
— APSTOXOfficial title:
Monitoring the Antiphospholipid Syndrome:TOXicity of Drugs (APSTOX)
NCT number | NCT03994302 |
Other study ID # | CIC1421-19-10 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2019 |
Est. completion date | April 8, 2023 |
Verified date | April 2023 |
Source | Groupe Hospitalier Pitie-Salpetriere |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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).
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 |
Country | Name | City | State |
---|---|---|---|
France | AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM | Paris |
Lead Sponsor | Collaborator |
---|---|
Groupe Hospitalier Pitie-Salpetriere |
France,
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 |
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