Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(V01AA03) house dust mites
house dust mites

Medical condition to be studied

Rhinitis allergic
Conjunctivitis allergic
Perennial allergy
Population studied

Age groups

Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)

Estimated number of subjects

1500
Study design details

Main study objective

To further describe the safety and tolerability of ORYLMYTE® during the first treatment year in adolescents and adults suffering from moderate to severe House Dust Mites (HDM)-induced allergic rhinitis (AR) or allergic rhinoconjunctivitis (ARC), with or without controlled asthma.

Outcomes

All adverse events (AEs) having occurred from the first intake of ORYLMYTE® until the end of the study. Effect of the treatment on the allergic symptoms and on the use of symptomatic medication, patient’s well-being, effect of the treatment on sleep, pharmacoeconomic impact of the treatment (in terms of absenteeism).

Data analysis plan

AE will be classified by Preferred Term (PT) and corresponding System Organ Class (SOC) using the current MedDRA terminology. Patients with AEs will be summarized as follows: - Patients with at least one Adverse Event (AE), at least one Adverse Drug Reaction (ADR, i.e. an event related to ORYLMYTE), at least one Serious Adverse Event (SAE), at least one Serious Adverse Drug Reaction (SADR) - Patients with at least one ADR leading to definitive discontinuation of ORYLMYTE Numbers and percentages of patients with at least one reported AE will be tabulated by MedDRA SOC and PT as follows: - All AEs, SAEs, ADRs, SADRs - All ADRs by intensity, severe ADRs, ADRs leading to definitive discontinuation of ORYLMYTE