Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(L01EF03) abemaciclib
abemaciclib

Medical condition to be studied

Interstitial lung disease
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

3312
Study design details

Main study objective

The primary objective of this study is to investigate risk factors of ILD among patients with HR+/HER2– breast cancer receiving abemaciclib-containing regimens or endocrine monotherapy (both historical and concurrent cohorts) under the real world setting in Japan

Data analysis plan

The prevalence, incidence, and incidence rate of ILD for all treatment cohorts will be calculated. Kaplan-Meier method will be used to display the time until patients develop the first ILD (event-free period). The historical endocrine monotherapy cohort will be used for the primary comparator and the concurrent endocrine monotherapy cohort will be used.In the univariable Cox regression analysis, variables will be selected as candidates for the multivariable analysis based on statistical significance as well as clinical importance/relevance. Multivariable Cox proportional hazard analysis will be used to identify potential risk factors associated with time to ILD onset by each of the three treatment cohorts from variables identified from the univariable analysis, with or without potential interaction terms. Additional multivariable Cox regression analysis that will be conducted to include treatment cohorts as independent variable along with other candidate variables.