CompletedNot Applicable

Monitoring the IMmUological TOXicity of Drugs

France662 participantsStarted 2018-03-01

Plain-language summary

Several drugs and chemotherapies seem to have an impact on the immunological system. This study investigates reports of immunological toxicities, including the International classification of disease ICD-10 codes M05, M32, I78 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Case reported in the WHO's pharmacovigilance database till 02/01/2018 * Adverse event reported were including the MedDRA terms for immune arthritis, systemic lupus erythematosus, hepatitis, rheumatoid arthritis and capillary leak syndrome. Exclusion Criteria: * Chronology not compatible between the drug and the toxicity

What they're measuring

Arthritis, hepatitis, and lupus induced toxicity of Immune Checkpoint inhibitors (ICI) Identification and report of cases of arthritis or lupus associated with ICIs. The research includes the report with MedDRA terms:

Timeframe: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018

Trial details

NCT IDNCT03480529

SponsorGroupe Hospitalier Pitie-Salpetriere

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-03-10

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