Table 2.
Adverse reactions to peanut OIT on initial escalation day (Day 1)
| Adverse reactions and treatment | Ketotifen | Placebo |
|---|---|---|
| Total no. of doses of OIT, n |
36 |
18 |
| Total no. of patients reporting symptoms |
3/4 |
2/2 |
| Total no. of doses with symptoms, n (% of total OIT doses) |
8/36 (22%) |
12/18 (67%) |
| Anaphylaxis, n (% of total OIT doses) |
-* |
1 (5%) |
|
Symptoms n, (% of OIT doses) |
Ketotifen |
Placebo |
| Gastrointestinal |
6/36 (17%) |
11/18 (61%) |
| Cutaneous |
- |
1/18 (6%) |
| Lower respiratory |
2/36 (6%) |
1/18 (6%) |
| Oropharyngeal |
- |
2/18 (11%) |
| Upper respiratory |
- |
- |
| Cardiovascular |
- |
- |
| OtherA |
- |
2/18 (11%) |
|
Treatment n, (% of OIT doses) |
Ketotifen |
Placebo |
| Epinephrine |
- |
- |
| Diphenhydramine |
- |
- |
| Cetirizine or other** |
- |
1/18 (6%) |
| Prednisone |
- |
- |
| Salbutamol or other inhaled medication | - | 1/18 (6%) |
*(-) indicates nil reported.
Aother symptoms reported: Grade 1 headache.
**Other second generation antihistamine.