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Table 5 Adverse events experienced by 5% or more of all treated subjects

From: A phase 3 trial assessing the efficacy and safety of grass allergy immunotherapy tablet in subjects with grass pollen-induced allergic rhinitis with or without conjunctivitis, with or without asthma

  Treatment-emergent AEs Treatment-related AEs
AEs, no. (% of subjects experiencing) Placebo (n = 166) Grass AIT (n = 163) Placebo (n = 166) Grass AIT (n = 163)
Ear pruritus 1 (<1) 16 (10) 1 (<1) 16 (10)
Mouth edema 0 (0) 9 (6) 0 (0) 9 (6)
Oral pruritus 1 (<1) 29 (18) 1 (<1) 28 (17)
Nasopharyngitis 24 (14) 23 (14) 0 (0) 1 (<1)
Sinusitis 6 (4) 12 (7) 1 (<1) 0 (0)
URTI 15 (9) 17 (10) 0 (0) 0 (0)
Headache 12 (7) 8 (5) 1 (<1) 1 (<1)
Paraesthesia oral 2 (1) 14 (9) 2 (1) 14 (9)
Throat irritation 4 (2) 24 (15) 4 (2) 23 (14)
Urticaria 0 (0) 8 (5) 0 (0) 6 (4)
  1. AE Adverse event, AIT Allergy immunotherapy tablet, URTI Upper respiratory tract infection.