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 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.