Risk factors for cardiac events in carfilzomib-treated patients in the Marketscan database (20160186)

Study type

• Study topic:
  Disease /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

Abstract 20160186_Carfilzomib_31May2017