Table 2.
|
100 μg(n = 13) |
200 μg(n = 12) |
Total |
||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Adverse event |
Grade |
Grade |
|
||||||||||
1 | 2 | 3 | 4 | 5 | Subtotal | 1 | 2 | 3 | 4 | 5 | Subtotal | ||
Skin reaction |
12 |
0 |
0 |
0 |
0 |
12 |
12 |
0 |
0 |
0 |
0 |
12 |
24 |
Swallowing disturbance |
0 |
0 |
3 |
0 |
0 |
3 |
0 |
0 |
4 |
1 |
0 |
5 |
8 |
Diarrhea |
0 |
0 |
2 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
0 |
1 |
3 |
Fever |
2 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
Decreased lymphocytes count |
0 |
0 |
7 |
0 |
0 |
7 |
0 |
0 |
3 |
0 |
0 |
3 |
10 |
Decreased Na level |
0 |
0 |
2 |
0 |
0 |
2 |
0 |
0 |
2 |
0 |
0 |
2 |
4 |
Decreased Hb level |
0 |
0 |
3 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Elevated ALT/AST level |
0 |
0 |
2 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
Elevated uric acid level | 0 | 0 | 1 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
NOTE: Events occurring more than once are listed. Events of disease progression are not listed.