Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Study drug and medical condition

Medical condition to be studied

Food allergy
Population studied

Age groups

Children (2 to < 12 years)
Adolescents (12 to < 18 years)

Estimated number of subjects

200
Study design details

Main study objective

This observational study is being conducted to collect data on safety, health related quality of life (HRQoL), and health resource utilization (HRU) in patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy treated with Palforzia® over a 24-month period in a real-world setting in Germany.

Outcomes

• Incidence and description of all AEs and SAEs, related or not to Palforzia® • Incidence and description of all serious and non serious adverse drug reaction (ADRs) suspected to be related to Palforzia®, • Change in quality of life (EuroQol EQ-5D and Food Allergy Quality of Life Questionnaire FAQLQ) from baseline (i.e. enrollment visit) • Direct HRU (all-cause and related to Palforzia®): count and length (days) of hospitalizations and intensive care unit (ICU) stays, count of emergency room visits, outpatient visits, and epinephrine injections, and a

Data analysis plan

Statistical analysis will be descriptive. No formal hypothesis testing will be performed. Continuous variables will be summarized with non-missing observations, mean and standard deviation, median and interquartile range, minimum and maximum, and number of missing data. Categorical variables will be summarized by the frequency and percent distribution in each category for non-missing data and missing data, as appropriate. 95% confidence intervals of means and percentages will be provided as appropriate. Time-to-event outcomes will be assessed using Kaplan-Meier analysis, as appropriate. Additional details, including subgroups of interest, will be described in the statistical analysis plan.