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

NCT01058122 | Completed DMC

• 1 other identifier: kein Sponsor
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Drug Reactions

Keywords

Adverse drug reactions in patients on the oncology ward

Study Arms (1)

Patients on the ward

Procedure: Collection of adverse drug events

Interventions

Collection of adverse drug events PROCEDURE

Patients on the ward

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients hospitalized at the oncology ward G and H of the university hospital zurich during the 5-month observation period

You may qualify if:

• German-speaking patients,
• At least 18 years old.

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University hospital zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• 01 Studienregister MasterAdmins

  UniversitaetsSpital Zuerich

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: January 28, 2010
• Study Start: August 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

CH (1)