Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin (Regulatory Post Marketing Commitment Plan)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 451
- 主要终点
- Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane
研究概览
简要总结
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.
详细描述
All the patients whom an investigator prescribes the first Exemestane (Aromasin) should be registered.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with postmenopausal breast cancer (including ovariectomy etc.).
排除标准
- •Patients cannot be evaluated.For example, not administered Exemestane (Aromasin).
研究组 & 干预措施
Exemestane
Patients taking Exemestane Tablets.
干预措施: Exemestane (Drug)
结局指标
主要结局
Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane
时间窗: 24 weeks
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).
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
时间窗: 24 weeks
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)
Number of Participants With Adverse Drug Reaction
时间窗: 24 weeks
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.
Number of Tumor Responders in Progressive Breast Cancer or Recurrent Breast Cancer to Exemestane Treatment
时间窗: 24 weeks
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.
Number of Post-operative Adjuvant Therapy Participants With Breast Cancer Recurrence Status
时间窗: 24 weeks
次要结局
- Number of Participants With Unexpected Adverse Drug Reaction(24 weeks)
- Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction(24 weeks)
- Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction(24 weeks)