Monitoring the IMmUological TOXicity of Drugs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

662 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2018-03-10

Brief Summary

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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).

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Detailed Description

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Several drugs and chemotherapies seem to have an impact on the immunological system and are responsible of a wide range of rare immunological side effects. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by rare immunological side effects (of which systemic lupus, immune arthritis, rheumatoid arthritis, Hepatitis, capillary leak syndrome) imputed to drugs. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Conditions

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Arthritis Systemic Lupus Erythematosus Rheumatoid Arthritis Capillary Leak Syndrome Hepatitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Arthritis or lupus or CLS induced by a drug

Case reported in the World Health Organization (WHO) of arthritis or lupus, or Hepatitis, or capillary leak syndrome of patient treated by a drug, with a chronology compatible with the drug toxicity

drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom

Intervention Type DRUG

Drugs susceptible to induce arthritis, lupus, hepatitis, or capillary leak syndrom

Interventions

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drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom

Drugs susceptible to induce arthritis, lupus, hepatitis, or capillary leak syndrom

Intervention Type DRUG

Eligibility Criteria

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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.