Evaluation of Risk Factors Associated With Myelosuppression (Grade 4 Neutropenia) in Breast Cancer Patients Treated With Palbociclib in the Post-marketing Setting: Nested Case-control Study Using the Medical Information Database Network (MID-NET) Database
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 4,184
- 试验地点
- 1
- 主要终点
- Number of Participants With Risk Factors for Grade 4 Neutropenia in Users of Palbociclib
研究概览
简要总结
The purpose of this study is to explore risk factors for grade 4 neutropenia in users of the study medicine Palbociclib for the potential treatment of Palbociclib.
This study is seeking participants:
- treated with the study medicine Palbociclib
- having any breast cancer records in same month as the initiation date
- having prescription records of palbociclib from 15 December 2017 to 29 February 2024
The study design is a nested case control study. This study design uses de-identified patient data from a hospital based electronic medical record and claim database in Japan. This design was selected since the primary objective is to explore risk factors of Grade 4 neutropenia in users of the study medicine Palbociclib.
One of the important side effects of taking Palbociclib is neutropenia (decreased count of neutrophils - a type of white blood cell).
In this study the effect of Palbociclib in decreasing the neutrophil count was studied after it was released to the market.
To do that, the study gathered details of breast cancer patients newly treated with Palbociclib from 23 hospitals and 10 medical institutes across Japan.
The below patient details were collected:
- dose of Palbociclib
- other medicines prescribed for cancer
- age
- gender
- past information on cancer treatments
- laboratory findings at baseline
The result was based on the neutrophil count collected from the laboratory data.
Around 1300 patients newly treated with Palbociclib for breast cancer was calculated by the medical information database network (MID-NET) in 6 years from 15 December 2017.
Patients who develop grade 4 neutropenia after palbociclib initiation will be matched to controls who do not develop grade 4 neutropenia. A statistical model will be used to explore risk factors of grade 4 neutropenia adjusted for important potential confounding factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having prescription records of palbociclib from 15 December 2017 to 29 February
- •Having any breast cancer records in same month as the first prescription date.
排除标准
- •Having an ANC less than the threshold value for grade 4 neutropenia within 30 days of the first prescription of palbociclib
- •Having any records of anti-HER2 medication
结局指标
主要结局
Number of Participants With Risk Factors for Grade 4 Neutropenia in Users of Palbociclib
时间窗: 01 Jun 2017 through 29 Feb 2024
Grade 4 neutropenia, as the outcome of this study, will be defined as an absolute neutrophil count (ANC) of less than 0.5 × 109 cells/L or less than 500 cells/mL during the "on-treatment" period.
次要结局
- Number of Participants With Risk Factors for Grade 4 Neutropenia in New Users of Palbociclib(20 Dec 2016 through 29 Feb 2024)