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临床试验/NCT05912933
NCT05912933已完成不适用

Evaluation of Incidence of Myelosuppression (Grade 4 Neutropenia) in Breast Cancer Patients With Mild, Moderate or Severe Hepatic Impairment Treated With Palbociclib Compared to Patients With Reserved Hepatic Function in the Post-marketing Setting: Cohort Study Using the Medical Information Database Network (MID-NET) Database

Pfizer2 个研究点 分布在 1 个国家目标入组 1,342 人开始时间: 2024年8月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Pfizer
入组人数
1,342
试验地点
2
主要终点
Number of Participants With/Without Hepatic Impairment for Grade 4 Neutropenia in New Users of Palbociclib

研究概览

简要总结

The purpose of this study is to evaluate incidence of grade 4 neutropenia in patients who have hepatic impairment and use the study medicine Palbociclib.This study is seeking participants: - treated with the study medicine Palbociclib - having any breast cancer records in same month as the index date (the first prescription date) - having prescription records of palbociclib from 20 December 2016 to 29 February 2024The study design is a cohort study. This study design uses de-identified patient data from a hospital based electronic medical record and claim database in Japan.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 relationship between neutropenia caused by Palbociclib and hepatic impairment 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 baselineThe 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.

研究设计

研究类型
Observational
观察模型
Cohort
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

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. - Having laboratory tests and visit records (SS-MIX2) on or before 180 days prior to the first prescription date- Having SS-MIX2 hospital-visit records within 180 days before the first prescription date

排除标准

  • Having an absolute neutrophil count (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/Without Hepatic Impairment for Grade 4 Neutropenia in New Users of Palbociclib

时间窗: 20 Dec 2016 through 29 Feb 2024

Grade 4 neutropenia, as the outcome of this study, will be defined as an ANC of less than 0.5 × 10\^9 cells/L or less than 500 cells/mL during the "on-treatment" period.

次要结局

  • Number of Participants With/Without Hepatic Impairment for Grade 3-4 Neutropenia in New Users of Palbociclib(20 Dec 2016 through 29 Feb 2024)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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