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)
|