Study of the safety and tolerability of STALORAL® Birch and STALORAL® Birch/Alder/Hazel with a maximum dose of 300 IR daily in routine application in adults (GO FOR 300)

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:
  (V01AA05) tree pollen

  tree pollen
• Medical condition to be studied:
  Rhinitis allergic

  Conjunctivitis allergic

Population studied

• Age groups:
  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:
  450

Study design details

• Main study objective:
  To further describe the safety and tolerability of STALORAL® Birch and STALORAL® Birch/Alder/Hazel at a maximum dose of 300 IR/daily in routine practice in adults suffering from allergic rhinitis, conjunctivitis or rhinoconjunctivitis induced by tree pollen.
• Outcomes:
  All adverse events (AEs) that occur on or after the day of first intake of the medicinal product and up to the end of the observation period. Effect of the treatment on the allergic symptoms and on the use of symptomatic medication, patient’s well-being
• Data analysis plan:
  An overall summary of all AEs, including the number of events and the number and percentage of patients with AEs is drawn up. AEs are summarised on the basis of MedDRA SOC and PT. Further tabular summaries are compiled for SAEs, ADRs (events with a possible causal relationship with STALORAL® Birch or STALORAL® Birch/Alder/Hazel), SADRs, ADRs by severity, ADRs leading to withdrawal from the study, ADRs during the initiation phase (dose escalation phase) or during the course of the treatment (maintenance phase), ADRs requiring medical treatment and ADRs or situations of special interest. Also analysed are the time to occurrence of the ADRs (time interval from the last administration of STALORAL® Birch or STALORAL® Birch/Alder/Hazel), duration and time course of the ADRs. The statistical evaluation of further outcomes takes place descriptively.