Table 2: Treatment-emergent adverse events (TEAEs) during oral immunotherapy (OIT).

From: Safety and efficacy of short-term oral immunotherapy with Cry j 1-galactomannan conjugate for Japanese cedar pollinosis: a randomized controlled trial

TEAE, No. (%)Treat (N = 26)Placebo (N = 28)
TotalBuild-up phaseMaintenance phaseTotalBuild-up phaseMaintenance phase
Total6 (23.0)5 (19.2)2 (7.6)5 (17.8)4 (14.2)2 (7.1)
 Mild (Grade 1)6 (23.0)5 (19.2)2 (7.6)5 (17.8)4 (14.2)2 (7.1)
 Moderate (Grade 2)0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)
 Severe (Grade 3)0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)
Discontinued immunotherapy0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)
Preferred term, No. (%)
Oral dysesthesia0 (0)0 (0)0 (0)1 (3.5)1 (3.5)0 (0)
Diarrhea1 (3.8)1 (3.8)0 (0)0 (0)0 (0)0 (0)
Loose stools0 (0)0 (0)0 (0)1 (3.5)1 (3.5)0 (0)
Abdominal pain1 (3.8)1 (3.8)0 (0)2 (7.1)0 (0)2 (7.1)
Abdominal discomfort1 (3.8)1 (3.8)0 (0)0 (0)0 (0)0 (0)
Bloating1 (3.8)1 (3.8)0 (0)0 (0)0 (0)0 (0)
Stomach pain2 (7.6)1 (3.8)2 (7.6)0 (0)0 (0)0 (0)
Chest discomfort0 (0)0 (0)0 (0)1 (3.5)1 (3.5)0 (0)
Laryngopharyngeal dysesthesia0 (0)0 (0)0 (0)1 (3.5)1 (3.5)0 (0)
Rhinorrhoea1 (3.8)1 (3.8)0 (0)0 (0)0 (0)0 (0)
Watering eyes0 (0)0 (0)0 (0)1 (3.5)1 (3.5)0 (0)
  1. AEs were graded according to Co mmon Terminology Criteria for Adverse Event (CTCAE) v4.0/MedDRA v12.0.