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

University of Zurich (UZH) logo

University of Zurich (UZH)

Status

Completed

Conditions

Adverse Drug Reactions

Treatments

Procedure: Collection of adverse drug events

Study type

Observational

Funder types

Other

Identifiers

NCT01058122
kein Sponsor

Details and patient eligibility

About

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.

Enrollment

129 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

129 participants in 1 patient group

Patients on the ward
Treatment:
Procedure: Collection of adverse drug events

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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