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 ?
We performed, for the first time, a causality assessment of this drug toxicity and found a high probability of a causal relationship between diazoxide and pericardial effusion.
ADR causality assessment is used to determine the likelihood that a drug caused a particular suspected ADR.
HILI was diagnosed according to the Chinese Society of Hepatology guidelines and Roussel Uclaf Causality Assessment Method score.
Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccination.
Aguilar said they used the World Health Organization (WHO) Algorithm for Causality Assessment of Adverse Events Following Immunizations (AEFI).
The expert panel used the World Health Organization's algorithm for causality assessment of adverse events following immunization, a systematic, scientifically sound and universally accepted proof of assessing causality of events following any vaccination, she said.
We also applied the more standardized causality assessment for drug-induced hepatotoxicity, RUCAM (Roussel Uclaf Causality Assessment Method).
The Roussel Uclaf Causality Assessment Method score was 9, which was consistent with highly probable DILI.
The causality assessment pointed toward a probable/likely association as per the Naranjo algorithm and the WHO--UMC scale.
All suspected ADRs were initially assessed by the Consultant Incharge--Diabetes Clinic and subsequently the information was collected and analyzed by the pharmacologists for causality assessment.
Using the 2016 Roussel Uclaf Causality Assessment Method (RUCAM) score as highlighted in Table 2, the relationship between this herbal tea and liver injury was determined [26].