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

December 15, 2009
January 27, 2010
August 2007
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT01058122 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Collection, Evaluation and Assessment of Adverse Drug Reactions on the Oncology Ward
Collection, Evaluation and Assessment of Adverse Drug Reactions on the Oncology Ward

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Adverse Drug Reactions
Procedure: Collection of adverse drug events
Patients on the ward
Intervention: Procedure: Collection of adverse drug events
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
October 2009
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01058122
kein Sponsor
Yes
Clinical pharmacology and toxicology, University hospital zurich
University of Zurich
Ylinical Pharmacology and Toxicology
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
University of Zurich
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP