Post-Market Claims-Based Study of Allergic Reactions and Eosinophilic Esophagitis in Marketed Use of GRASTEK? in the United States (MK-7243-025)

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:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  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)
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  To further describe the safety profile of GRASTEK in marketed use in the US and to monitor the incidence of serious allergic reactions and EoE in participants using GRASTEK.
• Outcomes:
  Describe the characteristics of participants initiating GRASTEK (demographics, concomitant medications, co-morbidities).Estimate the incidences of the following in participants newly receiving GRASTEK: 1) serious allergic reactions and 2) EoE.Conduct an analysis of exposed participants to describe potential baseline risk factors for serious allergic reactions and EoE.
• Data analysis plan:
  Participants treated with GRASTEK and participants experiencing events of interest will be described according to all available demographic characteristics, prescription medications, co-morbidities and characteristics of GRASTEK 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.