Post-injection Syndrome in Patients with Schizophrenia Receiving Olanzapine Long-Acting Injection (F1D-MC-B034)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N05AH03) olanzapine

  olanzapine
• Medical condition to be studied:
  Schizophrenia

Population studied

• Short description of the study population:
  Adult patients with schizophrenia whose physician has decided to treat with olanzapine LAI.; Male or female patients, at least 18 years of age who have been diagnosed with schizophrenia and willing to participate in the study and have signed a consent form to release medical information were included.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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:
  Patients with schizophrenia
• Estimated number of subjects:
  5000

Study design details

• Main study objective:
  The primary objective is to estimate the incidence per injection and per patient of post-injection syndrome events in schizophrenia patients receiving olanzapine long-acting injection.
• Outcomes:
  Post-injection syndrome, - Clinical presentation and outcomes of post-injection syndrome- Potential risk factors association with post-injection syndrome- Hospitalization at baseline and post-baseline
• Data analysis plan:
  For primary analysis, the crude incidence of post-injection syndrome events and 95% confidence intervals will be calculated based on the total number of patients enrolled in the study and the total number of injections given in the study period. Post-injection syndrome events used in the incidence will be based on adjudicated cases. Secondary analyses will include descriptive statistics of the study population and characterize the clinical presentation of post-injection syndrome events, including outcome. Adjusted odds ratios and 95% confidence intervals will be calculated using logistic regression to identify risk factors for patients experiencing post-injection syndrome events. Hospitalization at baseline (previous 6- or 12-months) and post-baseline will be tabulated for all enrolled patients. Descriptive statistics will be used to describe the frequency and duration of hospitalization.Additional analyses include the summarization of adverse events and serious adverse events.