| |
Start of updosing |
|
| |
Up to peak GPS |
After peak GPS |
Total |
| |
N (%) E* |
N (%) E* |
N (%) E* |
| Total number of patients |
198 |
52 |
250 |
| Injection site swelling
(entire observation period) |
112 (56.6%) 734 |
25 (48.1%) 162 |
137 (54.8%) 896 |
| Injection site swelling
(short-time up-dosing to 10,000 SQ-U) |
98 (49.5%) 326 |
24 (46.2%) 96 |
122 (48.8%) 422 |
| Other ADR (entire observation period) |
47 (23.7%) 163 |
6 (11.5%) 46 |
53 (21.2%) 209 |
| ≤ 30 min after injection |
11 ( 5.6%) 46 |
1 ( 1.9%) 3 |
12 ( 4.8%) 49 |
| > 30 min after injection |
31 (15.7%) 98 |
3 ( 5.8%) 10 |
34 (13.6%) 108 |
| Missing values |
5 ( 2.5%) 19 |
2 ( 3.8%) 33 |
7 ( 2.8%) 52 |
| Intensity |
|
|
|
| mild |
24 (12.1%) 94 |
1 ( 1.9%) 34 |
25 (10.0%) 128 |
| moderate |
16 ( 8.1%) 48 |
1 ( 1.9%) 5 |
17 ( 6.8%) 53 |
| severe |
5 ( 2.5%) 9 |
4 ( 7.7%) 7 |
9 ( 3.6%) 16 |
| missing values |
2 ( 1.0%) 19 |
- |
2 ( 0.8%) 12 |
| Treated by medication |
30 (15.2%) 100 |
5 ( 9.6%) 35 |
35 (14.0%) 120 |
| Serious |
4 ( 2.0%) 10 |
1 ( 1.9%) 4 |
5 ( 2.0%) 14 |
| Treatment terminated |
7 ( 3.5%) 12 |
- |
7 ( 2.8%) 16 |
*E: Number of events |
