POST AUTHORIZATION SAFETY STUDY OF FEXINIDAZOLE FOR HUMAN AFRICAN TRYPANOSOMIASIS : Analysis of real-life safety and effectiveness data on fexinidazole, collected by NSSCP & WHO as part of NSSCP activity as per WHO interim guidelines 2019 (FEXINC09395)

Study type

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

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Database analysis

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  FEXINIDAZOLE
• Anatomical Therapeutic Chemical (ATC) code:
  (P01CA03) fexinidazole

  fexinidazole
• Medical condition to be studied:
  African trypanosomiasis

Population studied

• Age groups:
  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)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  To evaluate safety of fexinidazole when used in field conditions of the National sleeping sickness control program.
• Outcomes:
  Occurrence of any adverse events during the treatment period at end of treatment(EOT) and at end of hospitalization (EOH) if different of EOT and 6 months follow-up visit with special focus on AE included in the safety specifications in the RMP, Relapse occurrence according to relapse characteristics: date of occurrence, clinical or biological diagnosis, and rescue treatment.
• Data analysis plan:
  Baseline demographic and clinical characteristics, treatment given as well as safety and effectiveness outcomes will be the object of descriptive analysis. Analysis will include treatment provided, dose, duration, compliance to instruction. The safety analysis will include the number and percentage of patients with any adverse events, the stratifications by intensity (severity), seriousness and other characteristics, deaths during treatment and their description, pregnancy outcomes, as well as outcomes of children exposed in utero to fexinidazole, within two years following the birth. Major AEs will be defined as those with intensity described as severe, very severe, or lethal, by the reporter.