Electronic Study for Anastrozole Pharmacovigilance Evaluation (E-SAFE)
July 25, 2008 updated by: AstraZeneca
Collecting information regarding adverse events from patients on treatment with anastrazole with early stage breast cancer
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1850
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Post-menopausal Early Invasive Breast Cancer Patients who are under anastrazole treatment, who have normal renal and hepatic functions.
Exclusion Criteria:
- Metastatic breast cancer patients, previous hormonal therapy, other malignancies.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nejdet Uskent, Kadir Has University Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
November 13, 2007
First Submitted That Met QC Criteria
November 13, 2007
First Posted (Estimate)
November 14, 2007
Study Record Updates
Last Update Posted (Estimate)
July 28, 2008
Last Update Submitted That Met QC Criteria
July 25, 2008
Last Verified
July 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARI-IPEP-0104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.