| |
e
|
n (%)
|
|---|
|
IMP-related adverse events
|
95
|
34 (36.6)
|
|
Severity
|
|
Mild
|
95
|
34 (36.6)
|
|
Moderate
|
0
|
0
|
|
Severe
|
0
|
0
|
|
Change in treatment schedule
|
|
None
|
93
|
33 (35.5)
|
|
Temporarily interrupted
|
2
|
1 (1.1)
|
|
Discontinued
|
0
|
0
|
|
Prior to first intake
|
0
|
0
|
|
Classification according to EAACI guideline
|
|
LR
|
85
|
32 (34.4)
|
|
SR
|
9
|
4 (4.3)
|
|
Grade 0/Nonspecific
|
1
|
1 (1.1)
|
|
Dose
|
|
300 SQ+
|
16
|
13 (14.0)
|
|
600 SQ+
|
11
|
11 (11.8)
|
|
3,000 SQ+
|
24
|
22 (23.7)
|
|
6,000 SQ+
|
17
|
17 (18.3)
|
|
15,000 SQ+
|
26
|
15 (16.1)
|
|
Dose unknown
|
1
|
1 (1.1)
|
-
ADR adverse drug reaction, e number of events, EAACI European Academy of Allergy and Clinical Immunology, n (%) number and percentage of subjects, LR local reactions, SQ+ standardized quality units, SR systemic reactions
