Study type

Study topic

DiseaseĀ /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Disease epidemiology

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Retrospective cohort study
Study drug and medical condition

Name of medicine

KYPROLIS

Medical condition to be studied

Plasma cell myeloma
Population studied

Short description of the study population

Newly diagnosed multiple myeloma patients treated with carfilzomib beginning in January 1, 2005 through June 30, 2015.

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)

Special population of interest

Other

Special population of interest, other

Multiple myeloma patients

Estimated number of subjects

350
Study design details

Main study objective

The aim of this observational study is to describe the differences between carfilzomib-treated Multiple Myeloma (MM) patients who do and do not have cardiac events in the Marketscan administrative database in the United States.

Outcomes

Aim 1: Identify and estimate the incidence rate of defined cardiac events in carfilzomib-treated MM patients during the treatment period and 30 day period after termination of treatment.Aim 2: Compare the demographic and clinical characteristics of carfilzomib-treated patients with and without the occurrence of defined cardiac events, Aim 1: Assess defined cardiac event incidence and association by cumulative duration of carfilzomib treatment and by line of treatment that carfilzomib is administered Exploratory Objective: Compare the incidence rates of defined cardiac events from the carfilzomib-treated cohort to non-carfilzomib-treated cohort.

Data analysis plan

The primary outcomes of interest in this study will be any cardiac events. Cardiac events will be defined as hypertension including malignant hypertension, heart failure, ischemic heart disease including acute myocardial infarction, cardiac arrhythmias and conduction disorders, or cardiomyopathy. Incidence rates for each type of defined cardiac event will be estimated using traditional methods (eliminating those with prevalent cardiac events at treatment start date from the numerator and denominator, prevalent cardiac conditions is defined by occurrence of a claim for the cardiac events in the baseline period). A patient will be counted in the numerator of the incidence rate at the time of the first diagnosis. Patient follow up begins at treatment index and continues until first occurrence of the outcome for those experiencing an event of interest. For event-free patients, follow-up begins at treatment index and ends 30 days after the end of active carfilzomib-treatment. Explorator
Documents
Study results
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