|
Total AEs
|
546 (89.2)
|
3789
|
163.0
|
87.4
|
|
Infections and infestationsb
|
420 (68.6)
|
1257
|
54.1
|
36.4
|
|
Tuberculosisc
|
6 (1.0)
|
6
|
0.26
|
0.26
|
|
Herpes zosterc
|
10 (1.6)
|
11
|
0.47
|
0.43
|
|
Neoplasms (benign, malignant and unspecified)b
|
19 (3.1)
|
20
|
0.9
|
0.8
|
|
Most frequent AEs by preferred term (ER >4.0 per 100 PYs)
|
|
Upper respiratory tract infections
|
93 (15.2)
|
154
|
6.6
|
4.4
|
|
Nasopharyngitis
|
67 (10.9)
|
101
|
4.3
|
3.1
|
|
Urinary tract infections
|
65 (10.6)
|
94
|
4.0
|
3.0
|
|
AEs leading to withdrawal
|
119 (19.4)
|
157
|
N/A
|
5.2
|
|
AEs leading to death by system organ class
|
19 (3.1)
|
25
|
N/A
|
0.8
|
|
Neoplasms (benign, malignant and unspecified)
|
5 (0.8)
|
5
|
N/A
|
0.2
|
|
Cardiac disorders
|
4 (0.7)
|
6
|
N/A
|
0.2
|
|
Nervous system disorders
|
4 (0.7)
|
4
|
N/A
|
0.2
|
|
Injury, poisoning and procedural complications
|
4 (0.7)
|
4
|
N/A
|
0.2
|
|
Infections and infestations
|
2 (0.3)
|
2
|
N/A
|
0.03
|
|
Hepatobiliary disorders
|
1 (0.2)
|
1
|
N/A
|
0.04
|
|
Musculoskeletal and connective tissue disorders
|
1 (0.2)
|
1
|
N/A
|
0.04
|
|
Total SAEs by system organ class
|
219 (35.8)
|
364
|
15.7
|
11.2
|
|
Infections/infestations
|
90 (14.7)
|
105
|
4.5
|
4.1
|
|
Musculoskeletal and connective tissue disorders
|
47 (7.7)
|
65
|
2.8
|
2.1
|
|
Neoplasms (benign, malignant and unspecified)
|
27 (4.4)
|
29
|
1.3
|
1.2
|
|
Injury, poisoning and procedural complications
|
23 (3.8)
|
25
|
1.1
|
1.0
|
