N/A
N=451
Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin
Breast Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00932165 ↗Enrolled (actual)
451
Serious AEs
0.4%
Results posted
Jun 2010
Primary outcome: Primary: Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane — 126; 324; 372; 68 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Exemestane (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane |
126; 324; 372; 68; 10 | — |
| PRIMARY Number of Participants With Performance Status Score Based on Eastern Cooperative Oncology Group (ECOG) Factors Considered to Affect the Safety and/or Efficacy of Exemestane |
385; 47; 9; 6; 3 | — |
| PRIMARY Number of Participants With Adverse Drug Reaction |
58 | — |
| PRIMARY Number of Tumor Responders in Progressive Breast Cancer or Recurrent Breast Cancer to Exemestane Treatment |
1; 5; 12; 32 | — |
| PRIMARY Number of Post-operative Adjuvant Therapy Participants With Breast Cancer Recurrence Status |
3; 317 | — |
| SECONDARY Number of Participants With Unexpected Adverse Drug Reaction |
2; 1; 1; 1; 1; 1 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction |
1; 1; 2; 1; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subjects with postmenopausal breast cancer (including ovariectomy etc.).
Exclusion Criteria
- Patients cannot be evaluated.For example, not administered Exemestane (Aromasin).
Data sourced from ClinicalTrials.gov (NCT00932165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.