Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin

NCT ID: NCT00932165

Last Updated: 2010-07-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

451 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-12-31

Study Completion Date

2008-11-30

Brief Summary

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The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Detailed Description

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All the patients whom an investigator prescribes the first Exemestane (Aromasin) should be registered.

Conditions

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Breast Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Exemestane

Patients taking Exemestane Tablets.

Exemestane

Intervention Type DRUG

Aromasin® Tablets 25mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. " The usual adult dose is 25 mg of exemestane administered orally once daily after a meal."

Interventions

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Exemestane

Aromasin® Tablets 25mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. " The usual adult dose is 25 mg of exemestane administered orally once daily after a meal."

Intervention Type DRUG

Other Intervention Names

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Aromasin

Eligibility Criteria

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Inclusion Criteria

* Subjects with postmenopausal breast cancer (including ovariectomy etc.).

Exclusion Criteria

* Patients cannot be evaluated.For example, not administered Exemestane (Aromasin).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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Other Identifiers

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A5991078

Identifier Type: -

Identifier Source: org_study_id

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