Post-Market Claims-Based Study of Serious Allergic Reactions and Eosinophilic Esophagitis in Marketed Use of RAGWITEK? in the United States (MK-3641-010)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Case-series

Study drug and medical condition

• Medical condition to be studied:
  Anaphylactic reaction

  Eosinophilic oesophagitis

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  To further describe the safety profile of RAGWITEK in marketed use in the United States and to monitor the incidence of serious allergic reactions and EoE in participants using RAGWITEK
• Outcomes:
  To describe the characterisitics of participants initiating RAGWITEK with respect to demographics, concomitant medications and co-morbidities.To estimate the incidences of: 1) serious allergic reactions resulting in hospitalization, emergency department care or epinephrine injection in the ambulatory setting and 2) EoE, in participants newly receiving RAGWITEK.
• Data analysis plan:
  Participants treated with RAGWITEK and participants experiencing events of interest will be described according to all available demographic characteristics, presecription medications, comorbidities and characteristics of RAGWITEK treatment. For each of the two end points (serious allergic reactions and cases of EoE), multivariate models will be constructed using confirmed cases as the dependent variable and various baseline factors as potential independent variables among new users. Results of case series analyses will be presented as estimates of rate ratios and 95% confidence intervals for each identified risk factor.