Table 3.
Summary of toxicity in Trial 2 using the CDCA1 containing vaccine
|
Vaccine doses |
1.0 mg (n=3) |
3.0 mg (n=3) |
Total patients (n=6) |
|||
|---|---|---|---|---|---|---|
| |
Grade |
Grade |
(%) |
|||
| 1-2 | 3(4) | 1-2 | 3(4) | |||
| Blood/bone marrow |
|
|
|
|
|
|
| Anemia |
2 |
0 |
2 |
0 |
4 |
(67) |
| Thrombocytopenia |
0 |
0 |
1 |
0 |
1 |
(17) |
| Hepatic |
|
|
|
|
|
|
| Elevated AST |
0 |
0 |
0 |
(1) |
1 |
(17) |
| Elevated ALT |
0 |
0 |
0 |
(1) |
1 |
(17) |
| Constitutional symptoms |
|
|
|
|
|
|
| Fatigue |
0 |
0 |
3 |
0 |
3 |
(50) |
| Fever |
1 |
0 |
1 |
0 |
2 |
(33) |
| Gastrointestinal |
|
|
|
|
|
|
| Nausea/vomiting |
0 |
0 |
2 |
0 |
2 |
(33) |
| Anorexia |
0 |
0 |
2 |
0 |
2 |
(33) |
| Constipation |
1 |
0 |
0 |
0 |
1 |
(17) |
| Dermatology/skin |
|
|
|
|
|
|
| Rash |
3 |
0 |
3 |
0 |
6 |
(100) |
| Pruritus |
3 |
0 |
2 |
0 |
5 |
(83) |
| Reaction at the injection site | 3 | 0 | 3 | 0 | 6 | (100) |