TABLE II.

Overall safety data

Milk doses per child, mean (range)		209 (36-334)
Total doses		2301
Symptom/treatment	No. (%) of total doses	No. of reactions per child, mean (range)
Total reactions	41 (1.8)	3.7 (1-7)
Grade 1 (mild) symptoms	29 (1.3)	2.6 (1-5)
On rush desensitization day	14
During weekly dose  escalation phase	10
During maintenance dosing	5
Grade 2 (moderate) symptoms	8 (0.3)	0.7 (0-2)
On rush desensitization day	5
During weekly dose  escalation phase	1
During maintenance dosing	2
Grade 3 (severe) symptoms	4 (0.1)	0.3 (0-1)
On rush desensitization day	2
During weekly dose  escalation phase	1
During maintenance dosing	1

Total number of subjects = 11.

Grading of reactions was defined by Bock et al.¹ Grade 1 (mild) reactions did not require medications, whereas for any grade 2 (moderate) reaction, antihistamine was administered, and, in 2 cases, epinephrine was administered (by parent). Grade 3 (severe) reactions included 1 reaction during rush desensitization with severe rhinitis and moderate urticaria, treated with epinephrine (by physician); 1 reaction of generalized urticaria and severe rhinitis during the DBPCFC treated with antihistamines; 1 reaction of tongue swelling during the rush desensitization responding to oral antihistamines; and a reaction of severe abdominal pain during the home maintenance dosing, resolving with antihistamines. Reactions occurring at home were self-reported in diaries up to 24 to 28 weeks and were reported by phone or electronic mail throughout the study. Ten subjects have completed all 52 weeks of the study; reporting is complete for all subjects up to 36 weeks of the study.