Non-interventional multi-country prospective cohort study to investigate patterns of use of Selincro® and frequency of adverse drug reactions in routine clinical practice (START)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Alcohol use

Population studied

• 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:
  2000

Study design details

• Main study objective:
  - Patterns of use of Selincro® in routine clinical practice,- Frequency of adverse drug reactions of special interest inpatients treated with Selincro® in routine clinical practice in theentire study population and in the subpopulations of interest.
• Outcomes:
  Characteristics at initiation of Selincro®: socio-demographics, % with alcohol dependence diagnosis, psychiatric comorbidities or somatic comorbidities, % with increased ALAT/ASAT (>3ULN, if available), % with psychosocial support, % with CNS-active medicines and opioids, pregnancy and lactation, off-label use. Patterns of use overall and by sub-group.Occurrence of adverse drug reactions, overall and by sub-group.
• Data analysis plan:
  In this non-comparative cohort study, all data analyses will be purely descriptive and no statistical testing will be performed as the primary study objectives are to investigate the patterns of use of Selincro® and the frequency of ADRs of special interest in patients treated with Selincro® in routine clinical practice in the entire study population and in the subpopulations of interest.These descriptive analyses will be conducted in the entire study population and in the subpopulations of interest (if relevant), and by country.Summary statistics (mean, standard deviation SD, median, interquartile range IQR, minimum, and maximum values) will be presented for continuous variables and counts and, if relevant, percentages will be presented for categorical and binary variables.