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

This study has been completed.
Sponsor:
Collaborator:
Ylinical Pharmacology and Toxicology
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT01058122
First received: December 15, 2009
Last updated: January 27, 2010
Last verified: January 2010
History of Changes
  Purpose

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 Intervention Phase
Adverse Drug Reactions
 Procedure: Collection of adverse drug events
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collection, Evaluation and Assessment of Adverse Drug Reactions on the Oncology Ward

Further study details as provided by University of Zurich:

Study Start Date: August 2007
Estimated Study Completion Date: October 2009
Groups/Cohorts Assigned Interventions
Patients on the ward Procedure: Collection of adverse drug events

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058122

Locations
Switzerland
University hospital zurich
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Ylinical Pharmacology and Toxicology
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: Clinical pharmacology and toxicology, University hospital zurich
ClinicalTrials.gov Identifier: NCT01058122     History of Changes
Other Study ID Numbers: kein Sponsor
Study First Received: December 15, 2009
Last Updated: January 27, 2010
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Zurich:
Adverse drug reactions in patients on the oncology ward

Additional relevant MeSH terms:
Drug Toxicity
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on June 17, 2013