causality assessment

causality assessment

An evaluation performed by a medical professional regarding the likelihood that a therapy or product being assessed in a clinical trial caused or contributed to an adverse event.
References in periodicals archive ?
Tests to demonstrate drug-dependent antibodies were not performed in the presented patient and therefore the drug causality assessment was based on the relationship between drug intake and the onset of thrombocytopenia, as previously reported.
Standardization of nomenclature and causality assessment in drug-induced liver injury.
In all the groups, allergic skin reactions or pseudoallergic skin reactions were noted using causality assessment.
A diagnostic algorithm was now applied in the 4 patients with suspected BC hepatotoxicity, which included the qualitative and quantitative causality assessment of the updated system of the Council for International Organizations of Medical Sciences (CIOMS), allowing the study to objectively assess, score and scale the probability in each case.
In addition to its sophisticated causality assessment, analysis and documentation tools, the ADE Assistant provides the means for clinicians to submit timely, enhanced voluntary reporting of observed adverse drug events.
Benefits of attending: - Gain an overview of the European Regulatory Framework - Be aware of Volume IXb - Learn about VICH - Understand Adverse Event Reporting - Hear about Causality Assessment - Minimize the Impact of Data with Errors - Know about Requirements for Periodic Safety Update Reports - Literature Searches Explained - Understand the Implications of the Proposed EU Pharmacovigilance LegislationDocumentation: - Participants will receive a course material folder containing comprehensive documentation provided by the speakers, which will be a valuable source of reference for the future.
Nevertheless, despite the various prediposing factors a causality assessment of very probable is warranted between kava treatment and the observed hepatotoxicity.
The most commonly reported adverse experiences in adults and adolescents 15 years and older occurring more often than with placebo regardless of causality assessment, were headache, influenza, abdominal pain, cough, and dyspepsia.
Patients who suffered from liver disorders in 2000 were excluded from this study because the follow-up period was not sufficient for causality assessment.
Adverse Experiences Occurring in (greater than or equal to) 1% of Patients with an Incidence Greater than that in Patients Treated with Placebo, Regardless of Causality Assessment SINGULAIR Placebo 10 mg/day (%) (%) (n=1955) (n=1180) Body As A Whole Asthenia/fatigue 1.
In clinical studies involving HIV-uninfected patients age 12 years and older receiving Alinia Tablets, the most common adverse events reported regardless of causality assessment were abdominal pain (6.
This re-evaluation of case reports applied the latest qualitative and quantitative causality assessment and diagnostic algorithm of the Council for International Organizations of Medical Sciences (CIOMS).