Pharmaco-epidemiologic study on occurrence of adverse events

Study type

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

  Drug utilisation

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  EFFENTORA

Population studied

• Short description of the study population:
  a) Patients naive to Effentora® treatment;; b) patients about to start a titration with Effentora®;; c) patients who agreed to particpate in the study and provided a signed Informed Consent form
• 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:
  90

Study design details

• Main study objective:
  To estimate rates of AEs occurring during treatment initiation, titration and stabilisation of Effentora, over the first 3 months following initiation, in a real-life setting.
• Outcomes:
  Rate of AEs in Effentora patients, during the first 3 months of treatment, Effentora treatment effectiviness.Physician and patient satisfaction with educational brochures
• Data analysis plan:
  The prevalence of an AE was the proportion of patients reporting this AE at a specified time point among the total population. The incidence rate of an AE was the number of new cases in a population at risk in a given timeperiod. Descriptive statistics were used to evaluate all the pertinent variables collected. Tables were stratified where appropriate. Results were stratified to account for factors that may have affected the reporting of AEs (age, pain ateiology, type of pain, concomitant medication, physician specialty).