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

NCT01058122 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 129

Last updated 2018-05-11

No results posted yet for this study

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

Interventions

PROCEDURE

Collection of adverse drug events

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • 01 Studienregister MasterAdmins · UniversitaetsSpital Zuerich

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01058122 on ClinicalTrials.gov