SHP617-404: A SWEDISH RETROSPECTIVE STUDY EVALUATING THE PATTERN OF PLENADREN USE FROM SWEDISH QUALITY REGISTRIES (SWE-DUS)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Open-ended, non-interventional, retrospective study, prescription event monitoring, case-series

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  HYDROCORTISONE
• Medical condition to be studied:
  Adrenal insufficiency

Population studied

• Short description of the study population:
  Patients treated with PLENADREN.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  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:
  20

Study design details

• Main study objective:
  The main objective of this study is to monitor any off-label use of PLENADREN.
• Outcomes:
  Percentage of patients prescribed PLENADREN who are <18 years of age, andPercentage of patients receiving PLENADREN for reasons other than treatment of AI (Adrenal insufficiency), Assessment of physician prescribing patterns for PLENADREN.
• Data analysis plan:
  A summary of the data incorporated in the analysis reports will be included in the annual Period Benefit-Risk Evaluation Report (PBRER) for PLENADREN.All continuous variables will be summarized using standard statistical measures (i.e number of observations, mean, standard deviation SD, median, minimum, and maximum). All categorical variables will be summarized in frequency tables. Demographic and baseline data, as well as disease and treatment characteristics data, will be summarized using descriptive statistics. The primary and secondary endpoints of the study will be presented descriptively and summarized using 95% CIs. Subgroup data will also be presented descriptively.