Physicians’ knowledge on the risks associated with Odomzo® exposure after the implementation of a risk minimization program (CLDE225A2405)

Study type

• Study type:
  Not applicable
• Scope of the study:
  Effectiveness study (incl. comparative)
• If ‘Not applicable’, further details on the study type:
  Physicians'knowledge test, Questionnaire

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
• Estimated number of subjects:
  5

Study design details

• Main study objective:
  Asessment of Physician's knowledge on the risks associated with Odomzo
• Outcomes:
  Primary objective: -To assess HCPs’ knowledge on the risk of teratogenicity associated with sonidegib exposure during pregnancy and impaired fertility after the delivery of the HCP educational materials including the DHCP letter. Secondary objective: To evaluate the delivery of educational materials to HCPs consisting of DCHP letter and HCP educational brochure.
• Data analysis plan:
  Milestones Dates when data collection starts and ends, and also final study reports dates will vary between the countries where the study is conducted and will depend on Odomzo®’s National Competent Authorities approval. Start of data collection: approximately one year after the drug is locally approved and available for prescription End of data collection: six months of local data collection. This may be extended to 12 months, if relevant data collection is not possible within 6 months, e.g. if more followup/reminders are needed in case of a low response rate Final report of study results: one year after the end of data collection in all countries which participate in this survey. Date of final study report submission Final study report: - one year after the end of data collection in all countries which participate in this survey