Table 3.
TEAE related to AIT and intensity of TEAEs
| 1-Strength (n = 45) |
Standard (n = 41) |
Overall (n = 86) |
||||
|---|---|---|---|---|---|---|
| n (%) | e | n (%) | e | n (%) | e | |
| Overall | 27 (60.0) | 129 | 20 (48.8) | 132 | 47 (54.7) | 261 |
| Mild | 110 (85.3) | 120 (90.9) | 230 (88.1) | |||
| Moderate | 16 (12.4) | 12 (9.1) | 28 (10.7) | |||
| Severe | 3 (2.3) | 0 | 3 (1.1) | |||
| General disorders and injection-site conditions | 26 (57.8) | 111 | 20 (48.8) | 124 | 46 (53.5) | 235 |
| At the injection site | 21 (46.7) | 49 | 14 (34.1) | 38 | 35 (40.7) | 87 |
| Swelling | ||||||
| Erythema | 13 (28.9) | 28 | 15 (36.6) | 51 | 28 (32.6) | 79 |
| Pruritus | 14 (31.1) | 24 | 7 (17.1) | 26 | 21 (24.4) | 50 |
| Pain | 2 (4.4) | 2 | 3 (7.3) | 7 | 5 (5.8) | 9 |
| Warmth | 3 (6.7) | 5 | 0 | 0 | 3 (3.5) | 5 |
| Hemorrhage | 1 (2.2) | 1 | 1 (2.4) | 1 | 2 (2.3) | 2 |
| Investigations | 1 (2.2) | 2 | 2 (4.9) | 7 | 3 (3.5) | 9 |
| Forced expiratory volume decreased | 1 (2.2) | 2 | 1 (2.4) | 1 | 2 (2.3) | 3 |
| Respiratory, thoracic, and mediastinal disorders | 3 (6.7) | 6 | 0 | 0 | 3 (3.5) | 6 |
| Nervous system disorders | 1 (2.2) | 1 | 1 (2.4) | 1 | 2 (2.3) | 2 |
| Headache | 1 (2.2) | 1 | 1 (2.4) | 1 | 2 (2.3) | 2 |
| Skin and subcutaneous tissue disorders | 2 (4.4) | 3 | 0 | 0 | 2 (2.3) | 3 |
n (%) refers to patients who experienced at least one TEAE. e, number of events (TEAEs); AIT allergen immunotherapy; IMP, investigational medicinal product; TEAE, treatment-emergent adverse event.