Table 3. Adverse reactions duringto peanut OIT build-up and home doses while on Ketotifen (initial 4 weeksday 2-week 4)

Adverse reactions and treatment / Build-up doses in clinic / Home doses
Ketotifen / Placebo / Ketotifen / Placebo
Total no. of doses of OIT, n / 4 / 2 / 108 / 33
Total no. of missed OIT doses, n / - / - / - / -
Total no. of patients reporting symptoms / 3 / 1 / 4 / 2
Total no. of doses with symptoms, n (% of total OIT doses) / 3/4 (75%) / 2/2 (100%) / 54/108 (50%) / 27/33 (82%)
Anaphylaxis, n (% of total OIT doses) / - / - / 1/108 (1%) / 1/33 (3%)
Symptoms
n, (% of OIT doses) / Ketotifen n, (% of total OIT doses) / Placebo n, (% of total OIT doses) / Ketotifen n, (% of total OIT doses) / Placebo n, (% of total OIT doses)
Gastrointestinal / 3/4 (75%) / 2/2 (100%) / 50/108 (46%) / 27/33 (82%)
Mild / 1/4 (25%) / - / 23/108 (21%) / 8/33 (24%)
Moderate / - / 2/2 (100%) / 9/108 (8%) / 12/33 (36%)
Severe / - / - / 5/108 (5%) / 6/33 (18%)
Unspecified severity / 2/4 (50%) / - / 13/108 (12%) / 1/33 (3%)
Cutaneous / - / 1/2 (50%) / 1/108 (1%) / 6/33 (18%)
Mild / - / 1/2 (50%) / - / 3/33 (9%)
Moderate / - / - / - / 1/33 (3%)
Severe / - / - / - / 1/33 (3%)
Unspecified severity / - / - / 1/108 (1%) / 1/33 (3%)
Lower respiratory / - / - / 6/108 (6%) / 2/33 (6%)
Mild / - / - / 4/108 (4%) / -
Moderate / - / - / 1/108 (1%) / -
Severe / - / - / - / -
Unspecified severity / - / - / 1/108 (1%) / 2/33 (6%)
Upper respiratory / - / - / 2/108 (2%) / -
Mild / - / - / 2/108 (2%) / -
Moderate / - / - / - / -
Severe / - / - / - / -
Unspecified severity / - / - / - / -
Oropharyngeal / - / - / 1/108 (1%) / -
Mild / - / - / - / -
Moderate / - / - / - / -
Severe / - / - / - / -
Unspecified severity / - / - / 1/108 (1%) / -
Cardiovascular / - / - / - / -
Other / - / - / 14/108 (13%) B / 2/33 (6%)B
Treatment
n, (% of OIT doses) / Ketotifen n, (% of total OIT doses) / Placebo n, (% of total OIT doses) / Ketotifen n, (% of total OIT doses) / Placebo n, (% of total OIT doses)
Epinephrine / - / - / - / 1/33 (3%)
Diphenhydramine / - / - / 1/108 (1%) / 1/33 (3%)
Cetirizine or other** / 1/4 (25%) / - / 7/108 (6%) / 5/33 (15%)
Prednisone / - / - / - / 1/33 (3%)
Salbutamol or other inhaled medication / - / - / 1/108 (1%) / -

B Other reported symptoms included: fever, headache, fatigue, pallor

**Other second generation antihistamine