Post Marketing Surveillance Study to Observe Safety and Effectiveness of BOSULIF
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Incidence of AEs
研究概览
简要总结
The purpose of this study is to look at how safe and effective is bosulif in routine clinical practice.
This study is seeking for participants who are:
- Patients who are being treated* or will be treated with Bosulif according to it's local product document under routine clinical practice (*Patients who initiated Bosulif treatment within one year before consent)
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
All participants in this study will receive bosulif. All participants who have entered this study should meet the usual prescribing criteria for bosulif as per the LPD. The participants will be treated with bosulif under routine clinical practice in Korea.
The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.
In this study all treatment and checking of the patients will be done as per the study doctor. The study can be performed in Korean health care centers where bosulif is prescribed to treat CML after the patients have agreed to take part in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are being treated* or will be treated with Bosulif according to it's local product document under routine clinical practice (*Patients who initiated Bosulif treatment within one year before consent)
- •Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
排除标准
- •- Patients to whom bosulif is contraindicated as per the local labeling- Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information
研究组 & 干预措施
Patients with newly diagnosed CP Ph+ CML
Patients newly-diagnosed with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML)
干预措施: Bosulif (Drug)
结局指标
主要结局
Incidence of AEs
时间窗: From the date of bosulif treatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028)
次要结局
- Molecular response: 'Molecular response (MR) 1', 'MR 2', 'MR3/Major MR(MMR)', 'MR 4.0', 'MR4.5', 'MR5'(From the date of bosulif treatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028))
- Relapse(From the date of bosulif reatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028))
- Cytogenetic response: CCyR, PCyR, mCyR, not achieved(From the date of bosulif treatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028))
- Hematologic response: CHR, not achieved(From the date of bosulif treatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028))
- Molecular response: EMR, MMR, MR4.0, MR4.5, not achieved(From the date of bosulif treatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028))
- Relapse after Bosulif response(From the date of bosulif treatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028))