Table 2. Treatment-emergent adverse events (TEAEs) during oral immunotherapy (OIT).
| TEAE, No. (%) | Treat (N = 26) |
Placebo (N = 28) |
||||
|---|---|---|---|---|---|---|
| Total | Build-up phase | Maintenance phase | Total | Build-up phase | Maintenance phase | |
| Total | 6 (23.0) | 5 (19.2) | 2 (7.6) | 5 (17.8) | 4 (14.2) | 2 (7.1) |
| Mild (Grade 1) | 6 (23.0) | 5 (19.2) | 2 (7.6) | 5 (17.8) | 4 (14.2) | 2 (7.1) |
| Moderate (Grade 2) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Severe (Grade 3) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Discontinued immunotherapy | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Preferred term, No. (%) | ||||||
| Oral dysesthesia | 0 (0) | 0 (0) | 0 (0) | 1 (3.5) | 1 (3.5) | 0 (0) |
| Diarrhea | 1 (3.8) | 1 (3.8) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Loose stools | 0 (0) | 0 (0) | 0 (0) | 1 (3.5) | 1 (3.5) | 0 (0) |
| Abdominal pain | 1 (3.8) | 1 (3.8) | 0 (0) | 2 (7.1) | 0 (0) | 2 (7.1) |
| Abdominal discomfort | 1 (3.8) | 1 (3.8) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Bloating | 1 (3.8) | 1 (3.8) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Stomach pain | 2 (7.6) | 1 (3.8) | 2 (7.6) | 0 (0) | 0 (0) | 0 (0) |
| Chest discomfort | 0 (0) | 0 (0) | 0 (0) | 1 (3.5) | 1 (3.5) | 0 (0) |
| Laryngopharyngeal dysesthesia | 0 (0) | 0 (0) | 0 (0) | 1 (3.5) | 1 (3.5) | 0 (0) |
| Rhinorrhoea | 1 (3.8) | 1 (3.8) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Watering eyes | 0 (0) | 0 (0) | 0 (0) | 1 (3.5) | 1 (3.5) | 0 (0) |
AEs were graded according to Co mmon Terminology Criteria for Adverse Event (CTCAE) v4.0/MedDRA v12.0.