Intralymphatic immunotherapy with tyrosine-adsorbed allergens: a double-blind, placebo-controlled trial

Respiratory Research

Table 2 Adverse events associated with the intralymphatic injections in the cohort for testing procedural safety (n = 32)

	All subjects (94 injections)	Active group (55 injections)	Control group (39 injections)	P-value
Local reactions
Pain	12 (12.8)	9 (16.4)	3 (7.7)	0.178
Itch	8 (8.5)	6 (10.9)	2 (5.1)	0.275
Paresthesia	6 (6.4)	4 (7.3)	2 (5.1)	0.513
Wheal	1 (1.1)	0 (0.0)	1 (1.8)	0.415
Heat sensation	1 (1.1)	1 (1.8)	0 (0.0)	0.585
Systemic reaction
Dyspnea	5 (5.3)	3 (5.5)	2 (5.1)	0.660
Wheezing	5 (5.3)	3 (5.6)	2 (5.1)	0.660
Chest discomfort	4 (4.3)	4 (7.3)	0 (0.0)	0.112
Headache	3 (3.2)	2 (3.6)	1 (2.6)	0.628
Chills	3 (3.2)	2 (3.6)	1 (2.6)	0.628
Palpitation	2 (2.1)	2 (3.6)	0 (0.0)	0.340
Urticaria	2 (2.1)	1 (1.8)	1 (2.6)	0.660
Itchy eyes	2 (2.1)	0 (0.0)	2 (5.1)	0.170
Itchy palms	1 (1.1)	1 (1.8)	0 (0.0)	0.585
Abdominal discomfort	1 (1.1)	1 (1.8)	0 (0.0)	0.585
Fever	1 (1.1)	1 (1.8)	0 (0.0)	0.585
Rhinorrhea	1 (1.1)	0 (0.0)	1 (2.6)	0.415
Postnasal drip	1 (1.1)	0 (0.0)	1 (2.6)	0.415
Sneezing	1 (1.1)	0 (0.0)	1 (2.6)	0.415
Hypersensitivity reactions*				0.273
Grade 0 (none)	88 (94.6)	52 (94.5)	36 (94.7)
Grade 1 (mild)	4 (4.3)	1 (1.8)	3 (7.7)
Grade 2 (moderate)	0 (0.0)	0 (0.0)	0 (0.0)
Grade 3 (severe)	1 (1.1)	1 (1.8)	0 (0.0)
Grade 4 (anaphylactic)	0 (0.0)	0 (0.0)	0 (0.0)

Data are shown in frequencies (%). *Hypersensitivity reactions were graded according to Müller's classification

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