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

Adverse Drug Reactions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058122
• Other study ID #: kein Sponsor
• Status: Completed
• Start date: August 2007
• Est. completion date: September 2008

Study information

• Verified date: May 2018
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• German-speaking patients,

• At least 18 years old.

Exclusion criteria:

• Patients who could not give her consent, or have given, and any minor patient.

Related Conditions & MeSH terms

• Adverse Drug Reactions
• Drug-Related Side Effects and Adverse Reactions

Intervention

Procedure:
• Collection of adverse drug events

Locations

Country	Name	City	State
Switzerland	University hospital zurich	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland,