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.
Study Type
OBSERVATIONAL
Enrollment
4,184
Pfizer New York
New York, New York, United States
Number of Participants With Risk Factors for Grade 4 Neutropenia in Users of Palbociclib
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.
Time frame: 01 Jun 2017 through 29 Feb 2024
Number of Participants With Risk Factors for Grade 4 Neutropenia in New Users of Palbociclib
Grade 4 neutropenia, as the outcome of this study, will be defined as an ANC of less than 0.5 × 109 cells/L or less than 500 cells/mL during the "on-treatment" period.
Time frame: 20 Dec 2016 through 29 Feb 2024
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.