Table 1.

Summary of the high-dose HDM allergoid clinical trials included in the pooled safety analysis

Study	Population		Treatment	n	Included in safety set of
	Indication	Age (years)			HDM-ALL	HDM-DBPC	HDM-RCT(UC)	Placebo
					(n = 279)	(n = 214)	(n = 65)	(n = 221)
97-09 Ma	Allergic rhinitis/rhinoconjunctivitis	18–58	1800 PNU	20	Yes	Yes	–	–
			Placebo	20	–	–	–	Yes
97-09 UKa	Allergic rhinitis/rhinoconjunctivitis	22–54	1800 PNU	15	Yes	Yes	–	–
			Placebo	15	–	–	–	Yes
AL0106ac EudraCT: 2006-000934-11	Allergic rhinitis/rhinoconjunctivitis	19–46	1800 PNU	51	Yes	Yes	–	–
			Placebo	57	–	–	–	Yes
Al0400ava	Allergic rhinitis/rhinoconjunctivitis	18–54	1800 PNU	69	Yes	Yes	–	–
			Placebo	66	–	–	–	Yes
Al1009ac EurdraCT: 2011-002248-29	Controlled allergic bronchial asthma and rhinitis/rhinoconjunctivitis	18–40	600 PNU	24	–	–	–	–
			1800 PNU	31	Yes	Yes	–	–
			3000 PNU	28	–	–	–	–
			5400 PNU	31	–	–	–	–
			Placebo	32	–	–	–	Yes
AL0104av EudraCT: 2004-003892-35	Allergic asthma with or without allergic rhinitis/rhinoconjunctivitis	6–406–40	–	–	–	–	–	–
		≥18	1800 PNU	28	Yes	Yes	–	–
		≥18	Placebo	31	–	–	–	Yes
		<12	1800 PNU	39	Yes	–	Yes	–
		12–17	1800 PNU	26	Yes	–	Yes	–
		6–17	Usual care	32	–	–	–	–

^aPerformed before introduction of the EudraCT database

HDM house dust mites, HDM-DBPC high-dose HDM allergoid AIT double-blind placebo controlled, HDM-RCT(UC) high-dose HDM allergoid AIT usual care controlled, HDM-ALL HDM-DBPC plus HDM-RCT(UC), PNU protein nitrogen units