Clinical Trial: Collection, Evaluation and Assessment of Adverse Drug Reactions on the Oncology Ward

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Collection, Evaluation and Assessment of Adverse Drug Reactions on the Oncology Ward

Brief Summary:

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.

Detailed Summary:
Sponsor: University of Zurich

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Zurich

Dates:
Date Received: December 15, 2009
Date Started: August 2007
Date Completion: October 2009
Last Updated: January 27, 2010
Last Verified: January 2010