Table 2. Adverse events Table 2. Adverse events Table 2. Adverse events Table 2. Adverse events Table 2. Adverse events Table 2. Adverse events Table 2. Adverse events Table 2. Adverse events Table 2. Adverse events
ILIT after SCIT- 10 000 Events (No. patients) ILIT after SCIT- 10 000 Events (No. patients) ILIT after SCIT- 10 000 Events (No. patients) ILIT after SCIT- 10 000 Events (No. patients) ILIT after SCIT- 10 000 Events (No. patients) ILIT after SCIT- 10 000 Events (No. patients) ILIT after SCIT- 10 000 Events (No. patients) ILIT after SCIT- 10 000 Events (No. patients) ILIT de novo- 3000 Events (No. patients) ILIT de novo- 3000 Events (No. patients) ILIT de novo- 3000 Events (No. patients) ILIT de novo- 3000 Events (No. patients) ILIT de novo- 3000 Events (No. patients) ILIT de novo- 3000 Events (No. patients) ILIT de novo- 3000 Events (No. patients) ILIT de novo- 3000 Events (No. patients)
Treatment Number of injection Dose SQ-U
Active
Active
Active
Active
Placebo
Placebo
Placebo
Placebo
Active
Active
Active
Active
Placebo
Placebo
Placebo
Placebo
1st 1000 2nd 3000 2nd 3000 3rd 10 000
1st
2nd
2nd
3rd
1st 1000 2nd 3000 2nd 3000 3rd 3000
1st
2nd
2nd
3rd
edness or itching ≤ 1 cm at injection site
5 (13) 6 (13) 6 (13)
7 (13)
2 (12)
0 (12)
0 (12)
0 (12)
9 (20†)
3 (18)
3 (18)
6 (13)
5 (20)
5 (19)
5 (19)
4 (19)
Redness >1cm ≤10 cm at injection site
1 (13)
0 (13)
0 (13)
2 (13)
0 (12)
1 (12)
1 (12)
0 (12)
2 (20†)
4 (18)
4 (18)
3 (13)
0 (20)
0 (19)
0 (19)
0 (19)
Redness > 10 cm ≤20 cm at injection site
0 (13)
0 (13)
0 (13)
0 (13)
0 (12)
0 (12)
0 (12)
0 (12)
0 (20†)
0 (18)
0 (18)
2 (13)
0 (20)
0 (19)
0 (19)
0 (19)
Sneezing, rhinorrhea, itchy eyes/nose/ throat
2 (13)
1 (13)
1 (13)
1 (13)
2 (12)
2 (12)
2 (12)
2 (12)
3 (20†)
4 (18)
4 (18)
0 (13)
4 (20)
5 (19)
5 (19)
4 (19)
Heavy breathing or tightness over the chest
0 (13)
0 (13)
0 (13)
0 (13)
0 (12)
0 (12)
0 (12)
0 (12)
1 (20†)
2 (18)
2 (18)
0 (13)
0 (20)
1 (19)
1 (19)
1 (19)
Mild abdominal symptoms or nausea
0 (13)
0 (13)
0 (13)
0 (13)
0 (12)
0 (12)
0 (12)
0 (12)
2 (20†)
0 (18)
0 (18)
0 (13)
1 (20)
0 (19)
0 (19)
1 (19)
Fatigue
0 (13)
1 (13)
1 (13)
1 (13)
2 (12)
3 (12)
3 (12)
2 (12)
1 (20†)
0 (18)
0 (18)
1 (13)
5 (20)
1 (19)
1 (19)
2 (19)
Headache
0 (13)
0 (13)
0 (13)
0 (13)
0 (12)
0 (12)
0 (12)
0 (12)
0 (20†)
1 (18)
1 (18)
0 (13)
0 (20)
2 (19)
2 (19)
0 (19)
Fever/muscle pain
0 (13)
0 (13)
0 (13)
0 (13)
0 (12)
1 (12)
1 (12)
0 (12)
1 (20†)
1 (18)
1 (18)
0 (13)
1 (20)
0 (19)
0 (19)
0 (19)
Skin itching distant from injection site
0 (13)
0 (13)
0 (13)
1 (13)
0 (12)
0 (12)
0 (12)
0 (12)
0 (20†)
4 (18)
4 (18)
0 (13)
1 (20)
2 (19)
2 (19)
0 (19)
Palpitations or dizziness
0 (13)
0 (13)
0 (13)
0 (13)
0 (12)
0 (12)
0 (12)
0 (12)
0 (20†)
1 (18)
1 (18)
0 (13)
0 (20)
0 (19)
0 (19)
1 (19)
Reactivation of herpes zoster
0 (13)
0 (13)
0 (13)
0 (13)
0 (12)
0 (12)
0 (12)
1 (12)
0 (20†)
0 (18)
0 (18)
0 (13)
0 (20) 0 (19) 0 (19) 0 (19)
Follow up after treatment
4 weeks
4 weeks
8 months 8 months
4 weeks
4 weeks
8 months
8 months
4 weeks 4 weeks
8 months
8 months
4 weeks 4 weeks
8 months
8 months
Low Lymphocytes in blood
0 (13) 0 (13) 0 (13) 0 (13) 0 (12) 0 (12) 1 (12‡) 1 (12‡) 0 (19) 0 (19) 1 (19 ‡) 1 (19 ‡) 0 (20) 0 (20) 0 (20) 0 (20)
Low Neutrophils in blood
1 (13§) 1 (13§) 0 (13) 0 (13) 0 (12) 0 (12) 0 (12) 0 (12) 0 (19) 0 (19) 1 (19 §) 1 (19 §) 0 (20) 0 (20) 1 (20 §) 1 (20 §)
† One patient received 1000 SQ-U two times. ‡ Lymphocytes in blood 1.0-1.02 x109/L. § Neutrophils in blood 1.6 x109/L. † One patient received 1000 SQ-U two times. ‡ Lymphocytes in blood 1.0-1.02 x109/L. § Neutrophils in blood 1.6 x109/L. † One patient received 1000 SQ-U two times. ‡ Lymphocytes in blood 1.0-1.02 x109/L. § Neutrophils in blood 1.6 x109/L. † One patient received 1000 SQ-U two times. ‡ Lymphocytes in blood 1.0-1.02 x109/L. § Neutrophils in blood 1.6 x109/L. † One patient received 1000 SQ-U two times. ‡ Lymphocytes in blood 1.0-1.02 x109/L. § Neutrophils in blood 1.6 x109/L. † One patient received 1000 SQ-U two times. ‡ Lymphocytes in blood 1.0-1.02 x109/L. § Neutrophils in blood 1.6 x109/L. † One patient received 1000 SQ-U two times. ‡ Lymphocytes in blood 1.0-1.02 x109/L. § Neutrophils in blood 1.6 x109/L. † One patient received 1000 SQ-U two times. ‡ Lymphocytes in blood 1.0-1.02 x109/L. § Neutrophils in blood 1.6 x109/L. † One patient received 1000 SQ-U two times. ‡ Lymphocytes in blood 1.0-1.02 x109/L. § Neutrophils in blood 1.6 x109/L. † One patient received 1000 SQ-U two times. ‡ Lymphocytes in blood 1.0-1.02 x109/L. § Neutrophils in blood 1.6 x109/L. † One patient received 1000 SQ-U two times. ‡ Lymphocytes in blood 1.0-1.02 x109/L. § Neutrophils in blood 1.6 x109/L. † One patient received 1000 SQ-U two times. ‡ Lymphocytes in blood 1.0-1.02 x109/L. § Neutrophils in blood 1.6 x109/L. † One patient received 1000 SQ-U two times. ‡ Lymphocytes in blood 1.0-1.02 x109/L. § Neutrophils in blood 1.6 x109/L. † One patient received 1000 SQ-U two times. ‡ Lymphocytes in blood 1.0-1.02 x109/L. § Neutrophils in blood 1.6 x109/L. † One patient received 1000 SQ-U two times. ‡ Lymphocytes in blood 1.0-1.02 x109/L. § Neutrophils in blood 1.6 x109/L. † One patient received 1000 SQ-U two times. ‡ Lymphocytes in blood 1.0-1.02 x109/L. § Neutrophils in blood 1.6 x109/L. † One patient received 1000 SQ-U two times. ‡ Lymphocytes in blood 1.0-1.02 x109/L. § Neutrophils in blood 1.6 x109/L.