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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01058122
First Posted: January 28, 2010
Last Update Posted: January 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ylinical Pharmacology and Toxicology
Information provided by:
University of Zurich
  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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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

Responsible Party: Clinical pharmacology and toxicology, University hospital zurich
ClinicalTrials.gov Identifier: NCT01058122     History of Changes
Other Study ID Numbers: kein Sponsor
First Submitted: December 15, 2009
First Posted: January 28, 2010
Last Update Posted: January 28, 2010
Last Verified: January 2010

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

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders