Table1: Profiles of
patients in the full analysis set for safety assessment (N=20)
|
Clinical
variables |
|
0.3
mg (n=7) |
1.0
mg (n=7) |
3.0
mg (n=6) |
Total
(n=20) |
|
Gender |
Men: Women |
2:5 |
5:2 |
3:3 |
10:10 |
|
Age |
Median (min-max) |
69.5
(53-78) |
63.0
(59-84) |
64.4
(41-66) |
65.1(41-84) |
|
Type of cancer |
Pancreatic
cancer |
5 |
2 |
5 |
12 |
|
|
Colon
cancer |
2 |
3 |
1 |
6 |
|
|
Gastric
cancer |
0 |
1 |
0 |
1 |
|
|
Bile duct cancer |
0 |
1 |
0 |
1 |
|
Metastasis |
(positive: negative) |
7:0 |
5:2 |
5:1 |
17:3 |
|
Prior surgery |
(positive: negative) |
4:3 |
5:2 |
3:3 |
12:8 |
|
Prior radiation therapy |
(positive: negative) |
2:5 |
2:5 |
3:3 |
7:13 |
|
Prior chemotherapy |
(positive: negative) |
6:1 |
6:1 |
6:0 |
18:2 |
|
ECOG PS |
(0:1) |
1:6 |
1:6 |
2:4 |
4:16 |
|
Treatment-related AEs |
|
|
|||
|
Fever |
Grade
1 |
1 |
|
|
1 |
|
Injection site extravasation |
Grade
2 |
|
|
1 |
1 |
|
Injection site reaction |
Grade
1 |
1 |
|
1 |
2 |
|
Skin induration |
Grade
1 |
1 |
1 |
|
2 |