Adverse Drug Reactions Clinical Trial
Official title:
Collection, Evaluation and Assessment of Adverse Drug Reactions on the Oncology Ward
The proposed cohort study collected within a 5-month observation period adverse drug reaction
(Adverse Drug Events - ADE) in patients at the Department of Oncology at the University of
Zurich. ADE have been recorded using prospective monitoring and assessed using standardized
algorithms regarding causality and severity. Data sources included information from the
medical records, laboratory values and internal rounds. Additional information has been
collected using a standardized patient questionnaire.
The primary endpoints of this study are to determine the frequency of ADE, the comparison of
the quality of data sources and collection methods for the detection of ADE in regard to
patient characteristics, size, number of medications, the category of ADE, severity,
causation, diagnosis, hospitalization, cause of hospitalization and medication cause.
Secondary endpoint is the assessment of the ADE causality, severity and predictability.
n/a
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