System Organ Class,
Preferred Term All Participants
(N=20) All Participants
(N=20)
Relationship Probably Possibly
All Treatment Related TEAEs 17 (85%) [118] (5.90) [58]a (2.90)
Gastrointestinal Disorders 12 (60%) [57] (2.85) 1 (5%) [14] (0.70)
Abdominal pain
7 (35%) [42] (2.10)
1 (5%) [7] (0.35)
Vomiting
8 (40%) [12] (0.60)
1 (5%) [7] (0.35)
Gastrointestinal disorder
3 (15%) [3] (0.15)
0
Immune System Disorders 11 (55%) [38] (1.90) 1 (5%) [26] (1.30)
Hypersensitivity
11 (55%) [38] (1.90)
1 (5%) [26] (1.30)
Skin and Subcutaneous Tissue Disorders 5 (25%) [15] (0.75) 2 (10%) [11] (0.55)
Urticaria
5 (25%) [15] (0.75)
2 (10%) [11] (0.55)
Respiratory, Thoracic and Mediastinal Disorders 3 (15%) [7] (0.35) 1 (5%) [6] (0.30)
Allergic respiratory symptoms
3 (15%) [4] (0.20)
[2] (0.10)