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