At a glance
ClinicalIndex Comparison RecordN/ACompleted· 451 enrolled
Drug / intervention
Exemestanedrug
Likely dose
Exemestane 25mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin (Regulatory Post Marketing Commitment Plan)
In Brief
An observational study evaluating Exemestane for Breast Neoplasms. Completed, enrolled 451 participants.
Detailed Summary
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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
Countries--
Collaborators--
Timeline
N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2004
Primary CompletionNov 2008
First PostedJul 2009
TodayJul 2026
First PostedJul 3, 2009
Enrollment StartDec 1, 2004
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 17.0 years ago
Interventions
Exemestanedrug
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."