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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.
All the patients whom an investigator prescribes the first Exemestane (Aromasin) should be registered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exemestane | Patients taking Exemestane Tablets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exemestane | 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." |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Factors Considered to Affect the Safety and/or Efficacy 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). | 24 weeks |
| 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 | Scale 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) | 24 weeks |
| Number of Participants With Adverse Drug Reaction | 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. | 24 weeks |
| Number of Tumor Responders in Progressive Breast Cancer or Recurrent Breast Cancer to Exemestane Treatment | 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Unexpected Adverse Drug Reaction | 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). | 24 weeks |
| Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction |
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Inclusion Criteria:
Exclusion Criteria:
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The patients whom an investigator involving A5991078 prescribes the Exemestane (Aromasin).
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Patients need to be administered Exemestane (Aromasin) in order to be enrolled in the surveillance.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exemestane | Exemestane(Aromasin) as prescribed by subject's physician |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exemestane | Exemestane(Aromasin) as prescribed by subject's physician |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants With Unexpected Adverse Drug Reaction | 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). | Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of exemestane. | Posted | Number | participants | 24 weeks |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exemestane | Exemestane(Aromasin) as prescribed by subject's physician |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA/J12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA/J12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C056516 | exemestane |
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|
| Number of Post-operative Adjuvant Therapy Participants With Breast Cancer Recurrence Status |
| 24 weeks |
The participants who were diagnosed by the investigator as the participants with hepatic dysfunction, and observed for safety information. |
| 24 weeks |
| Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction | The participants who were diagnosed by the investigator as the participants with renal dysfunction, and observed for safety information. | 24 weeks |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Number of Participants With Factors Considered to Affect the Safety and/or Efficacy 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). | Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of exemestane. | Posted | Number | participants | 24 weeks |
|
|
|
| Secondary | Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction | The participants who were diagnosed by the investigator as the participants with hepatic dysfunction, and observed for safety information. | Subjects with hepatic Dysfunction. | Posted | Number | participants | 24 weeks |
|
|
|
| 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 | Scale 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) | Posted | Number | participants | 24 weeks |
|
|
|
| Primary | Number of Participants With Adverse Drug Reaction | 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. | Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of exemestane. | Posted | Number | participants | 24 weeks |
|
|
|
| Secondary | Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction | The participants who were diagnosed by the investigator as the participants with renal dysfunction, and observed for safety information. | Subjects with renal Dysfunction. | Posted | Number | participants | 24 weeks |
|
|
|
| Primary | Number of Tumor Responders in Progressive Breast Cancer or Recurrent Breast Cancer to Exemestane Treatment | 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. | N = number of participants with tumor response | Posted | Number | participants | 24 weeks |
|
|
|
| Primary | Number of Post-operative Adjuvant Therapy Participants With Breast Cancer Recurrence Status | The participants who were evaluated for efficacy of Aromasin for the post-operative adjuvant therapy. | Posted | Number | participants | 24 weeks |
|
|
|
| 2 |
| 450 |
| 58 |
| 450 |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA/J12.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA/J12.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA/J12.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase abnormal | Investigations | MedDRA/J12.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA/J12.0 | Systematic Assessment |
|
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.
| D017437 |
| Skin and Connective Tissue Diseases |
| Title | Measurements |
|---|---|
|
| Past history (presence of at least one disease) |
|
| Unknown history |
|
|
| Arthralgia |
|
| Musculoskeletal stiffness |
|
| Aspartate aminotransferase increased |
|
| Gamma-glutamyltransferase increased |
|
| Title | Measurements |
|---|---|
|
| Symptomatic, >50% in bed |
|
| Bedbound |
|
| Measurements |
|---|
|
| Back pain |
|
| Gamma-glutamyltransferase abnormal |
|
| Title | Measurements |
|---|---|
|
| Progressive disease (PD) |
|