|
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. |