Any adverse event
|
22 (81.5)
|
23 (100)
|
35 (74.5)
|
41 (89.1)
|
Any serious adverse event
|
1 (3.7)
|
4 (17.4)
|
1 (2.1)
|
0 (0.0)
|
Any adverse event leading to discontinuation of study drug
|
5 (18.5)
|
3 (13.0)
|
2 (4.3)
|
0 (0.0)
|
Any infection or infestation adverse event
|
11 (40.7)
|
14 (60.9)
|
23 (48.9)
|
28 (60.9)
|
Most commonly reported adverse events
b
|
Nasopharyngitis
|
7 (25.9)
|
7 (30.4)
|
16 (34.0)
|
19 (41.3)
|
Liver function test abnormal
|
4 (14.8)
|
9 (39.1)
|
3 (6.4)
|
4 (8.7)
|
Leukopenia
|
4 (14.8)
|
1 (4.3)
|
0 (0.0)
|
3 (6.5)
|
Bradycardia
|
0 (0.0)
|
3 (13.0)
|
0 (0.0)
|
0 (0.0)
|
Influenza
|
0 (0.0)
|
3 (13.0)
|
0 (0.0)
|
2 (4.3)
|
Second-degree atrioventricular block
|
0 (0.0)
|
3 (13.0)
|
0 (0.0)
|
0 (0.0)
|
Headache
|
0 (0.0)
|
2 (8.7)
|
5 (10.6)
|
0 (0.0)
|
Lymphocyte count decreased
|
1 (3.7)
|
2 (8.7)
|
1 (2.1)
|
2 (4.3)
|
Lymphopenia
|
0 (0.0)
|
2 (8.7)
|
0 (0.0)
|
3 (6.5)
|
γ-glutamyltransferase increased
|
1 (3.7)
|
2 (8.7)
|
1 (2.1)
|
0 (0.0)
|
White blood cell count decreased
|
0 (0.0)
|
2 (8.7)
|
0 (0.0)
|
1 (2.2)
|
Eczema
|
0 (0.0)
|
1 (4.3)
|
1 (2.1)
|
4 (8.7)
|
Rash
|
2 (7.4)
|
1 (4.3)
|
1 (2.1)
|
0 (0.0)
|
Alanine aminotransferase increased
|
2 (7.4)
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
Blood triglycerides increased
|
2 (7.4)
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
Dental caries
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
3 (6.5)
|
Diarrhea
|
1 (3.7)
|
0 (0.0)
|
2 (4.3)
|
3 (6.5)
|
Stomatitis
|
1 (3.7)
|
1 (4.3)
|
0 (0.0)
|
3 (6.5)
|
Pharyngitis
|
0 (0.0)
|
1 (4.3)
|
1 (2.1)
|
3 (6.5)
|
Tinea pedis
|
1 (3.7)
|
1 (4.3)
|
3 (6.4)
|
0 (0.0)
|
Skin papilloma
|
0 (0.0)
|
0 (0.0)
|
3 (6.4)
|
0 (0.0)
|
Serious adverse events
| | | | |
Bradycardia
|
0 (0.0)
|
2 (8.7)
|
0 (0.0)
|
0 (0.0)
|
Leukoencephalopathyc
|
0 (0.0)
|
1 (4.3)
|
0 (0.0)
|
0 (0.0)
|
Multiple sclerosis relapse
|
0 (0.0)
|
0 (0.0)
|
1 (2.1)
|
0 (0.0)
|
Neuromyelitis optica
|
1 (3.7)
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
Abortion induced
|
0 (0.0)
|
1 (4.3)
|
0 (0.0)
|
0 (0.0)
|