Table 4 Adverse reactions to peanut OIT off ketotifen (week 4–44)
From: Effect of ketotifen premedication on adverse reactions during peanut oral immunotherapy
Adverse reactions and treatment | Build-up doses in clinic | Home doses | ||
|---|---|---|---|---|
Ketotifen | Placebo | Ketotifen | PlaceboC | |
Total no. of doses of OIT, n | 61 | 19 | 1221 | 373 |
Total no. of missed OIT doses, n | - | - | 1/1221 (.08%) | - |
Total no. of doses with symptoms, n (% of total OIT doses) | 19/61 (31%) | 15/19 (79%) | 156/1221 (13%) | 97/373 (26%) |
Anaphylaxis, n (% of total OIT doses) | - | - | 5/1221 (0.4%) | - |
Symptoms n, (% of OIT doses) | Ketotifen | Placebo | Ketotifen | Placebo |
Gastrointestinal | 9/61 (15%) | 15/19 (79%) | 95/1221 (8%) | 83/373 (22%) |
Cutaneous | - | - | 12/1221 (0.9%) | 15/373 (4%) |
Lower respiratory | 2/61 (3%) | 2/19 (11%) | 23/1221 (2%) | 12/373 (3%) |
Upper respiratory | 4/61 (6%) | - | 55/1221 (5%) | - |
Oropharyngeal | 2/61 (3%) | - | 12/1221 (0.9%) | - |
Cardiovascular | - | - | - | - |
Other | 8/61 (13%) | - | 122/1221 (10%)D | 12/373 (3%)D |
Treatment n, (% of OIT doses) | Ketotifen | Placebo | Ketotifen | Placebo |
Epinephrine | - | - | 1/1221 (0.08%) | - |
Diphenhydramine | - | - | 11/1221 (0.9%) | - |
Cetirizine** | - | - | 44/1221 (4%) | 1/373 (0.2%) |
Prednisone | - | - | 2/1221 (0.1%) | - |
Salbutamol or other inhaled medication | - | - | 27/1221 (2%) | 9/373 (2%) |