Evaluation of the safety profile of lurasidone: a post-authorization safety study using United States administrative claims databases (Lurasidone PASS program)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  LATUDA
• Medical condition to be studied:
  Schizophrenia

Population studied

• Age groups:
  Adolescents (12 to < 18 years)

  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:
  6611

Study design details

• Main study objective:
  The primary objective is to compare the incidence of important identified risks and important potential risks in patients treated with lurasidone to patients treated with other second generation oral atypical antipsychotics (OAAs).
• Outcomes:
  The primary outcomes include important risks to patients receiving OAAs, and those risks can be regarded as identified or potential
• Data analysis plan:
  The primary analyses will include:• Patient attrition• Descriptive statistics on the demographics and clinical characteristics of the two study cohorts • The number and percent of patients exposed to lurasidone and other OAAs• The number and percent of patients experiencing the outcomes of interest among the two study cohortsAnalyses will be conducted overall and for the subgroups specified.