Table 3. Adverse events.
| Adverse events | Active | Placebo | p-value |
|---|---|---|---|
|
| |||
| Number of AEs reported per subject – median (range) | 4 (0-34) | 5 (0-19) | 0.88 |
|
| |||
| Type of AE: | |||
| GI | 61 (23%) | 28 (23%) | 1 |
| Cutaneous | 17 (6.4%) | 6 (4.9%) | 0.65 |
| Respiratory | 56 (21.1%) | 22 (18%) | 0.59 |
| Ocular | 4 (1.5%) | 1 (0.8%) | 1 |
| Sinusitis | 4 (1.5%) | 2 (1.6%) | 1 |
| Pharyngitis | 15 (5.7%) | 13 (10.7%) | 0.09 |
| Headache | 29 (11%) | 8 (6.6%) | 0.20 |
| Lab abnormality | 11 (4.2%) | 3 (2.5%) | 0.56 |
| Food allergic reaction | 28 (10.6%) | 17 (13.9%) | 0.39 |
| SCIT reaction for AR | 0 | 3 (2.5%)* | 0.03 |
| Fever, no other symptoms | 2 (0.8%) | 1 (0.8%) | 1 |
| Other** | 38 (14.3%) | 18 (14.8%) | 1 |
|
| |||
| Severity: | |||
| Mild | 250 | 113 | |
| Moderate | 15 | 9 | 0.50 |
| Severe | 0 | 0 | |
|
| |||
| Relatedness: | |||
| Definitely | 1 | 0 | |
| Probably | 7 | 0 | |
| Possibly | 45 | 18 | 0.66 |
| Unrelated | 212 | 104 | 0.26 |
*
Reported for a single subject
**
Other symptoms included: tooth infection, yeast infection, neck pain, orthopedic injury, ingrown toenail, ingrown hair, epistaxis, general malaise, insect bite, cold sore, otitis externa, black eye, hot flashes, sun sensitivity, difficulty sleeping, UTI, salivary gland infection, fatigue, concussion, pain from braces, thrush