MedDRA system organ class MedDRA preferred term | Concomitant AIT n (%), E | No concomitant AIT n (%), E | All patients treated n (%), E |
---|---|---|---|
Patients | 160 | 21 | 181 |
All patients with ADRs | 49 (30.6), 358 | 8 (38.1), 37 | 57 (31.5), 395 |
Ear and labyrinth disorders | 8 (5.0), 18 | – | 8 (4.4), 18 |
Ear pruritus | 7 (4.4), 17 | – | 7 (3.9), 17 |
Eye disorders | 6 (3.8), 11 | – | 6 (3.3), 11 |
Eye pruritus | 3 (1.9), 4 | – | 3 (1.7), 4 |
Eye irritation | 2 (1.3), 6 | – | 2 (1.1), 6 |
Gastrointestinal disorders | 35 (21.9), 131 | 5 (23.8), 29 | 40 (22.1), 160 |
Oral pruritus | 14 (8.8), 34 | 1 (4.8), 6 | 15 (8.3), 40 |
Oedema mouth | 10 (6.3), 16 | 3 (14.3), 3 | 13 (7.2), 19 |
Paraesthesia oral | 8 (5.0), 21 | 3 (14.3), 10 | 11 (6.1), 31 |
Dysphagia | 6 (3.8), 11 | – | 6 (3.3), 11 |
Hypoaesthesia oral | 4 (2.5), 5 | 1 (4.8), 2 | 5 (2.8), 7 |
Oral discomfort | 4 (2.5), 6 | – | 4 (2.2), 6 |
Lip swelling | 2 (1.3), 2 | 2 (9.5), 6 | 4 (2.2), 8 |
Tongue pruritus | 3 (1.9), 4 | – | 3 (1.7), 4 |
Nausea | 3 (1.9), 4 | – | 3 (1.7), 4 |
Swollen tongue | 2 (1.3), 2 | – | 2 (1.1), 2 |
Lip pruritus | 2 (1.3), 2 | – | 2 (1.1), 2 |
Glossodynia | 2 (1.3), 4 | – | 2 (1.1), 4 |
Abdominal pain upper | 2 (1.3), 2 | – | 2 (1.1), 2 |
General disorders and administration site conditions | 11 (6.9), 38 | – | 11 (6.1), 38 |
Fatigue | 3 (1.9), 13 | _ | 3 (1.7), 13 |
Sensation of foreign body | 3 (1.9), 8 | – | 3 (1.7), 8 |
Injection site pruritus | 2 (1.3), 2 | – | 2 (1.1), 2 |
Infections and infestations | 2 (1.3), 6 | – | 2 (1.1), 6 |
Nasopharyngitis | 2 (1.3), 6 | – | 2 (1.1), 6 |
Nervous system disorders | 6 (3.8), 26 | 2 (9.5), 3 | 8 (4.4), 29 |
Headache | 3 (1.9), 19 | 2 (9.5), 3 | 5 (2.8), 22 |
Dizziness | 2 (1.3), 3 | – | 2 (1.1), 3 |
Respiratory, thoracic and mediastinal disorders | 30 (18.8), 94 | 3 (14.3), 4 | 33 (18.2), 98 |
Throat irritation | 13 (8.1), 34 | – | 13 (7.2), 34 |
Sneezing | 7 (4.4), 11 | – | 7 (3.9), 11 |
Cough | 5 (3.1), 8 | – | 5 (2.8), 8 |
Oropharyngeal pain | 3 (1.9), 8 | – | 3 (1.7), 8 |
Pharyngeal oedema | 2 (1.3), 3 | 1 (4.8), 2 | 3 (1.7), 5 |
Nasal discomfort | 2 (1.3), 2 | 1 (4.8), 1 | 3 (1.7), 3 |
Rhinorrhea | 3 (1.9), 4 | – | 3 (1.7), 4 |
Dyspnoea | 2 (1.3), 5 | – | 2 (1.1), 5 |
Nasal congestion | 2 (1.3), 5 | – | 2 (1.1), 5 |
Rhinitis allergic | 2 (1.3), 2 | – | 2 (1.1), 2 |
Dry throat | 2 (1.3), 2 | – | 2 (1.1), 2 |
Skin and subcutaneous disorders | 9 (5.6), 23 | 1 (4.8), 1 | 10 (5.5), 24 |
Pruritus | 6 (3.8), 17 | – | 6 (3.3), 17 |
Rash | 3 (1.9), 3 | – | 3 (1.7), 3 |