|
Any AE, n (%)
|
3 (100)
|
10 (67)
|
13 (72)
|
3 (60)
|
17 (61)
|
20 (61)
|
|
Any SAE, n (%)
|
0
|
0
|
0
|
0
|
2 (7)
|
2 (6)
|
|
Eye disorder
|
|
Retinal vein thrombosis
|
0
|
0
|
0
|
0
|
1 (4)
|
1 (3)
|
|
Injury, poisoning and procedural complications
|
|
Multiple fractures
|
0
|
0
|
0
|
0
|
1 (4)
|
1 (3)
|
|
Any AE leading to withdrawal, n (%)
|
0
|
0
|
0
|
0
|
3 (11)
|
3 (9)
|
|
Infections and infestations
|
|
Bronchitis
|
0
|
0
|
0
|
0
|
1 (4)
|
1 (3)
|
|
Eye disorder
|
|
Retinal vein thrombosis (SAE)
|
0
|
0
|
0
|
0
|
1 (4)
|
1 (3)
|
|
Injury, poisoning, and procedural complications
|
|
Multiple fractures (SAE)
|
0
|
0
|
0
|
0
|
1 (4)
|
1 (3)
|
|
Any treatment-related AEs, n (%)
|
3 (100)
|
2 (13)
|
5 (28)
|
1 (20)
|
6 (21)
|
7 (21)
|
|
Severe
|
0
|
0
|
0
|
0
|
1 (4)
|
1 (3)
|
|
Moderate
|
1 (33)
|
1 (7)
|
2 (11)
|
1 (20)
|
4 (14)
|
5 (15)
|
|
Mild
|
2 (67)
|
1 (7)
|
3 (17)
|
0
|
1 (4)
|
1 (3)
|
|
AEs occurring in > 10% of combined groups, n (%)
|
|
Musculoskeletal and connective tissue disorders
|
|
Arthralgia
| |
2 (11)
| |
2 (6)
|
|
Nervous system disorders
|
|
Headache
| |
2 (11)
| |
1 (3)
|
|
General disorders and administration site conditions
| |
|
Peripheral swellinga
| |
2 (11)
| |
0
|