An Observational Post-Authorization Modified Prescription-Event Monitoring Safety Study To Monitor The Safety And Utilization Of Asenapine (Sycrest) In The Primary Care Setting In England

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prescription event monitoring

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ASENAPINE MALEATE

Population studied

• Short description of the study population:
  Patients newly initiated on treatment with asenapine in the primary care setting in England.
• 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:
  5000

Study design details

• Main study objective:
  To study the utilisation and safety of asenapine in (asenapine naïve) new user patients and patients initiated in secondary care with shared care GP prescribing arrangements under normal conditions of use in primary care in England.
• Data analysis plan:
  Data analysis will include: • Hazard rates to explore the incidence of selected events • Descriptive analyses of baseline health profile of patients • Description of the risk profile of events reported in the 12 month observation period in the overall cohort and in patient subgroups of special interest • An assessment of clinical features and management of cases of suicide/ self injury (including overdose) in the cohort exposed to asenapine • Quantification of the incidence of frequently and rarely reported events and to identify previously unrecognised adverse drug reactions (ADRs)