Trial Outcomes & Findings for Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin (NCT NCT00932165)
NCT ID: NCT00932165
Last Updated: 2010-07-20
Results Overview
Assessment of factors likely to affect the safety and/or efficacy: reason for Exemestane use (primary progressive breast cancer, relapsed breast cancer or postoperative adjuvant therapy)and past history (presence or absence of at least one disease).
COMPLETED
451 participants
24 weeks
2010-07-20
Participant Flow
Patients need to be administered Exemestane (Aromasin) in order to be enrolled in the surveillance.
Participant milestones
| Measure |
Exemestane
Exemestane(Aromasin) as prescribed by subject's physician
|
|---|---|
|
Overall Study
STARTED
|
451
|
|
Overall Study
COMPLETED
|
450
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Exemestane
Exemestane(Aromasin) as prescribed by subject's physician
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin
Baseline characteristics by cohort
| Measure |
Exemestane
n=450 Participants
Exemestane(Aromasin) as prescribed by subject's physician
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
269 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
181 Participants
n=5 Participants
|
|
Age Continuous
|
62.67 years
STANDARD_DEVIATION 9.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
450 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
450 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of exemestane.
Assessment of factors likely to affect the safety and/or efficacy: reason for Exemestane use (primary progressive breast cancer, relapsed breast cancer or postoperative adjuvant therapy)and past history (presence or absence of at least one disease).
Outcome measures
| Measure |
Exemestane
n=450 Participants
Exemestane(Aromasin) as prescribed by subject's physician
|
|---|---|
|
Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane
Past history (nothing at all)
|
372 participants
|
|
Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane
Past history (presence of at least one disease)
|
68 participants
|
|
Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane
Unknown history
|
10 participants
|
|
Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane
Primary Progressive Breast Cancer
|
126 participants
|
|
Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane
Post-operative Adjuvant Therapy
|
324 participants
|
PRIMARY outcome
Timeframe: 24 weeksScale 0; Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1; Symptomatic but completely ambulatory (Restricted in physically strenuous activity ,ambulatory and able to carry out light or sedentary work), 2 ; Symptomatic, \<50% in bed during the day (Ambulatory,capable of all self care, unable to carry out any work activities., 3; Symptomatic, \>50% in bed, not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more waking hours), 4; Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair)
Outcome measures
| Measure |
Exemestane
n=450 Participants
Exemestane(Aromasin) as prescribed by subject's physician
|
|---|---|
|
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
Asymptomatic
|
385 participants
|
|
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
Symptomatic, completely ambulatory
|
47 participants
|
|
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
Symptomatic, <50% in bed during the day
|
9 participants
|
|
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
Symptomatic, >50% in bed
|
6 participants
|
|
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
Bedbound
|
3 participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of exemestane.
Confirmation of the number of subjects with treatment related adverse events. All adverse events regardless of causal relationship with Aromasin Tablet at the end of observation period was reported.
Outcome measures
| Measure |
Exemestane
n=450 Participants
Exemestane(Aromasin) as prescribed by subject's physician
|
|---|---|
|
Number of Participants With Adverse Drug Reaction
|
58 participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: N = number of participants with tumor response
Anti-tumor effect was evaluated according to the rules for 'General Rules for Clinical and Pathological Recording of Breast Cancer' (the 15th edition)/Response Evaluation Criteria in Solid Tumors (RECIST) Guideline. Judged as Completed response (CR) or partial response (PR), stable disease (SD) or progressive disease (PD) after the treatment start.
Outcome measures
| Measure |
Exemestane
n=50 Participants
Exemestane(Aromasin) as prescribed by subject's physician
|
|---|---|
|
Number of Tumor Responders in Progressive Breast Cancer or Recurrent Breast Cancer to Exemestane Treatment
Completed response (CR)
|
1 participants
|
|
Number of Tumor Responders in Progressive Breast Cancer or Recurrent Breast Cancer to Exemestane Treatment
Partial response (PR)
|
5 participants
|
|
Number of Tumor Responders in Progressive Breast Cancer or Recurrent Breast Cancer to Exemestane Treatment
Stable disease (SD)
|
12 participants
|
|
Number of Tumor Responders in Progressive Breast Cancer or Recurrent Breast Cancer to Exemestane Treatment
Progressive disease (PD)
|
32 participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: The participants who were evaluated for efficacy of Aromasin for the post-operative adjuvant therapy.
Outcome measures
| Measure |
Exemestane
n=320 Participants
Exemestane(Aromasin) as prescribed by subject's physician
|
|---|---|
|
Number of Post-operative Adjuvant Therapy Participants With Breast Cancer Recurrence Status
Recurrence present
|
3 participants
|
|
Number of Post-operative Adjuvant Therapy Participants With Breast Cancer Recurrence Status
Recurrence absent
|
317 participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of exemestane.
Adverse drug reaction that is not included in the "precautions for use"or "undesirable effects" section in the package insert (same as Local Product Document).
Outcome measures
| Measure |
Exemestane
n=450 Participants
Exemestane(Aromasin) as prescribed by subject's physician
|
|---|---|
|
Number of Participants With Unexpected Adverse Drug Reaction
Gastritis
|
2 participants
|
|
Number of Participants With Unexpected Adverse Drug Reaction
Hyperlipidaemia
|
1 participants
|
|
Number of Participants With Unexpected Adverse Drug Reaction
Angina pectoris
|
1 participants
|
|
Number of Participants With Unexpected Adverse Drug Reaction
Asthenia
|
1 participants
|
|
Number of Participants With Unexpected Adverse Drug Reaction
Dyspepsia
|
1 participants
|
|
Number of Participants With Unexpected Adverse Drug Reaction
Abdominal discomfort
|
1 participants
|
|
Number of Participants With Unexpected Adverse Drug Reaction
Constipation
|
1 participants
|
|
Number of Participants With Unexpected Adverse Drug Reaction
Hiatus hernia
|
1 participants
|
|
Number of Participants With Unexpected Adverse Drug Reaction
Erythema
|
1 participants
|
|
Number of Participants With Unexpected Adverse Drug Reaction
Urticaria
|
1 participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Subjects with hepatic Dysfunction.
The participants who were diagnosed by the investigator as the participants with hepatic dysfunction, and observed for safety information.
Outcome measures
| Measure |
Exemestane
n=54 Participants
Exemestane(Aromasin) as prescribed by subject's physician
|
|---|---|
|
Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction
Hot flush
|
1 participants
|
|
Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction
Abdominal discomfort
|
1 participants
|
|
Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction
Rash
|
1 participants
|
|
Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction
Arthralgia
|
1 participants
|
|
Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction
Musculoskeletal stiffness
|
1 participants
|
|
Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction
Aspartate aminotransferase increased
|
1 participants
|
|
Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction
Gamma-glutamyltransferase increased
|
1 participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Subjects with renal Dysfunction.
The participants who were diagnosed by the investigator as the participants with renal dysfunction, and observed for safety information.
Outcome measures
| Measure |
Exemestane
n=50 Participants
Exemestane(Aromasin) as prescribed by subject's physician
|
|---|---|
|
Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction
Hot flush
|
1 participants
|
|
Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction
Hepatic function abnormal
|
1 participants
|
|
Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction
Osteoporosis
|
2 participants
|
|
Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction
Back pain
|
1 participants
|
|
Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction
Gamma-glutamyltransferase abnormal
|
1 participants
|
Adverse Events
Exemestane
Serious adverse events
| Measure |
Exemestane
n=450 participants at risk
Exemestane(Aromasin) as prescribed by subject's physician
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
0.22%
1/450 • 1 year
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.22%
1/450 • 1 year
|
Other adverse events
| Measure |
Exemestane
n=450 participants at risk
Exemestane(Aromasin) as prescribed by subject's physician
|
|---|---|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.22%
1/450 • 1 year
|
|
Psychiatric disorders
Insomnia
|
0.22%
1/450 • 1 year
|
|
Nervous system disorders
Hypoaesthesia
|
0.22%
1/450 • 1 year
|
|
Nervous system disorders
Somnolence
|
0.44%
2/450 • 1 year
|
|
Nervous system disorders
Headache
|
0.22%
1/450 • 1 year
|
|
Nervous system disorders
Dizziness
|
0.22%
1/450 • 1 year
|
|
Vascular disorders
Hot flush
|
0.89%
4/450 • 1 year
|
|
Gastrointestinal disorders
Gastritis
|
0.44%
2/450 • 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
0.22%
1/450 • 1 year
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.22%
1/450 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.22%
1/450 • 1 year
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.22%
1/450 • 1 year
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.0%
9/450 • 1 year
|
|
Hepatobiliary disorders
Liver disorder
|
0.22%
1/450 • 1 year
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.22%
1/450 • 1 year
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.1%
5/450 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.22%
1/450 • 1 year
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.22%
1/450 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.22%
1/450 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
12/450 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.67%
3/450 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.44%
2/450 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.44%
2/450 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.44%
2/450 • 1 year
|
|
General disorders
Oedema
|
0.22%
1/450 • 1 year
|
|
General disorders
Oedema peripheral
|
0.22%
1/450 • 1 year
|
|
General disorders
Asthenia
|
0.22%
1/450 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
0.67%
3/450 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
0.89%
4/450 • 1 year
|
|
Investigations
Gamma-glutamyltransferase abnormal
|
0.22%
1/450 • 1 year
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.1%
5/450 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
- Publication restrictions are in place
Restriction type: OTHER