Table 3.

Double-blind, randomized studies (versus placebo, comparator) selected in this systematic review addressing only the evaluation of the safety profile.

Ref*	Age†	Cohort size	Diagnosis	Allergen	Administration type	Study duration	Safety
Children and adults
Birk et al.23	19–61	70	RC	Birch pollen	Out of season	26–29 days	5 SAEs with 2 and 4 DU 1 Ax with 8 DU
Devillier et al.38	14–50	484	Asthma	House-dust mite	Continuous	12 months	No SAEs No Ax
Nayak et al.58	18–50	80	RC	Ragweed pollen	Out of season	28 days	10 SAEs No Ax
Sieber et al.62	8–65	209	R	5-grass pollen	Coseasonal	3 consecutive seasons	No SAEs No Ax
Pfaar et al.67	18–65	80	R	12 grass pollens	Outside season	8 weeks	No SAEs No Ax
Calderón et al.97	18–42	43	R + Asthma	5-grass pollen	Out of season	28 days	No SAEs No Ax
Larsen et al.100	18–50	30	R	5-grass pollen	Out of season	10 days	8 SAEs No Ax
Malling et al.102	18–65	47	RC	Grass pollen	Pre-/coseasonal	8 weeks (pre) until end of season	No SAEs No Ax
Kleine-Tebbe et al.104	18–65	84	RC	Grass pollen	Outside season	28 days	No SAEs No Ax
Grosclaude et al.115	5–46	64	RC	5-grass pollen	Out of season	5 months ahead season, for 8 months	3 SAEs No Ax
Children
Maloney et al.32	12–17	195	R/RC	6- or 12-SQ house-dust mite	Out of season	28 days	No SAEs No Ax
Mösges et al.68	6–14	54	R	Birch pollen	Out of season	3 months	No SAEs No Ax
Ibañez et al.90	5–12	60	RC	SQ standardized grass pollen	Out of season	28 days outside the grass pollen season	18 SAEs No Ax

^*Subanalyses (with redundant results), pooled studies, or references with not available full-text were not included in the table.

^†Age is shown as range (minimum–maximum).

Ax, anaphylactic reaction; R, rhinitis; RC, rhinoconjunctivitis; SAE, severe or serious adverse events (related to SLIT).