Collection, Evaluation and Assessment of Adverse Drug Reactions on the Oncology Ward
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|ClinicalTrials.gov Identifier: NCT01058122|
Recruitment Status : Completed
First Posted : January 28, 2010
Last Update Posted : January 28, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Adverse Drug Reactions||Procedure: Collection of adverse drug events||Phase 4|
|Study Type :||Observational|
|Official Title:||Collection, Evaluation and Assessment of Adverse Drug Reactions on the Oncology Ward|
|Study Start Date :||August 2007|
|Estimated Study Completion Date :||October 2009|
|Patients on the ward||Procedure: Collection of adverse drug events|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058122
|University hospital zurich|
|Zurich, ZH, Switzerland, 8091|
|Study Director:||01 Studienregister MasterAdmins||UniversitaetsSpital Zuerich|