Risk Evaluation and Mitigation Strategy (REMS) Assessment Protocol - Zydelig (idelalisib) tablets (Zydelig REMS KAB)

Study type

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

  Other
• If ‘other’, further details on the scope of the study:
  KAB survey of risk minimization messages
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Survey of prescribers

Study drug and medical condition

• Name of medicine:
  ZYDELIG

Population studied

• Short description of the study population:
  Healthcare professionals in the U.S. who could potentially prescribe or have prescribed Zydelig (“intended users”). Intended users were identified using Zydelig targeted prescriber information or prescribing data provided by the Sponsor. Only intended users who have not participated in the survey pretesting or a prior assessment survey for Zydelig were invited to participate.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  The objective of this healthcare provider (HCP) assessment is to evaluate the effectiveness of the Zydelig REMS as determined by HCP knowledge and understanding of the risks of Zydelig, specifically that Zydelig can cause fatal and/or serious hepatotoxicity, fatal and/or serious and severe diarrhea or colitis, fatal and serious pneumonitis, and fatal and serious intestinal perforations.
• Data analysis plan:
  Responses to questions for all completed surveys will be tabulated, and summary tables will include simple descriptive statistics (e.g. mean, median, and standard deviations for continuous variables, and frequencies with percentages for categorical variables as appropriate). All results will be reported in aggregate and, where applicable, subanalyses of practice specialty, Zydelig prescription volume, and receipt of REMS materials will be included.