ETUDE POST AUTORISATION NON INTERVENTIONNELLE EN VIE REELLE DE SECURITE DES PATIENTS TRAITES PAR BACLOFÈNE ZENTIVA (BACLOFÈNE) (baclosafe)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Post authorization safety study on patient treated by zentiva baclofen for addictions

Study drug and medical condition

• Medicinal product name, other:
  baclofène
• Medical condition to be studied:
  Dependence

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:
  1000

Study design details

• Main study objective:
  incidence of SAEs related or not to Baclofene Zentiva in real life during one year follow up
• Outcomes:
  ncidence of SAEs related or not to Baclofene Zentiva in real life during one year follow up, incidence of AEs during one year association of AE and Demography or clinical data prescription in real life evolution of patients treated with Baclofene Zetniva SAEs related to drug according to investigator AEs related treatment stop specific situations with drugs
• Data analysis plan:
  incidenc will be calculated in patient/year with associated IC 95%