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Table 4 Adverse events reported with a least a possible relationship to SCIT for both study groups, classified in accordance with MedDRA

From: Allergy immunotherapy with a hypoallergenic recombinant birch pollen allergen rBet v 1-FV in a randomized controlled trial

System organ class AEs reported (Preferred terms) rBet v 1-FV (n = 24) Comparator (n = 27)
No. of patients with at least one AE (%) No. of Events No. of patients with at least one AE (%) No. of Events
Cardiac disorders Cardiovascular disorder 1 (4) 1 0 (0) 0
Eye disorders Eye pruritus, Lacrimation increased, Conjunctivitis 2 (8) 3 3 (11) 3
Gastrointestinal disorders Oral pruritus, Nausea 1 (4) 1 1 (4) 1
General disorders and administration site conditions Fatigue, Injection site erythema, Injection site swelling, Injection site pruritus, Injection site induration, Injection site pain, Injection site warmth 16 (67) 101 20 (74) 151
Immune system disorders Eyelid oedema, CSF monocyte count, Conjunctivitis allergic, Rhinitis allergic, Urticaria, Allergic cough, Asthma 7 (29) 23 5 (19) 11
Infections and infestations Herpes simplex, Rhinitis 2 (8) 3 2 (7) 2
Investigations Peak expiratory flow rate decreased 1 (4) 1 1 (4) 2
Psychiatric disorders Nervousness 0 (0) 0 1 (4) 1
Respiratory, thoracic and mediastinal disorders Asthma, Nasal congestion, Nasal discomfort, Pharyngolaryngeal pain, Chest discomfort, Cough, Dyspnoea 3 (12) 5 7 (26) 12
Skin and subcutaneous tissue disorders Erythema, Exanthem, Neurodermatitis, Rash pruritic, Swelling face, Urticaria, Urticaria generalised 6 (25) 8 1 (4) 1