Table 3. All grades AEs suspected to be study drug related occurring in at least 5% of all patients (safety cohort).
|
Weekly schedule |
Twice-weekly schedule |
|
|||||||
|---|---|---|---|---|---|---|---|---|---|
| |
2.5 mg (N=3) |
5 mg (N=5) |
10 mg (N=7) |
20 mg (N=6) |
30 mg (N=5) |
50 mg (N=22) |
60 mg (N=5) |
25 mg (N=11) |
All pts (N=64) |
| n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | |
| Pts with ≥1 drug-related AEs |
1 (33) |
3 (60) |
4 (57) |
6 (100) |
5 (100) |
22 (100) |
5 (100) |
11 (100) |
57 (89) |
|
Constitutional | |||||||||
| Asthenia | 0 | 2 (40) | 2 (29) | 2 (33) | 2 (40) | 11 (50) | 3 (60) | 4 (36) | 26 (41) |
| Insomnia |
0 |
0 |
0 |
0 |
1 (20) |
9 (41) |
2 (40) |
4 (36) |
16 (25) |
|
Gastrointestinal | |||||||||
| Diarrhoea | 0 | 3 (60) | 2 (29) | 6 (100) | 4 (80) | 18 (82) | 5 (100) | 9 (82) | 47 (73) |
| Nausea | 0 | 0 | 0 | 3 (50) | 1 (20) | 6 (27) | 2 (40) | 2 (18) | 14 (22) |
| Anorexia | 1 (33) | 0 | 2 (29) | 1 (17) | 1 (20) | 7 (32) | 2 (40) | 2 (18) | 16 (25) |
| Abdominal pain | 0 | 0 | 0 | 4 (67) | 1 (20) | 3 (14) | 1 (20) | 1 (9) | 10 (16) |
| Vomiting | 0 | 1 (20) | 0 | 1 (17) | 0 | 5 (23) | 2 (40) | 0 | 9 (14) |
| Weight loss |
0 |
0 |
1 (14) |
0 |
0 |
2 (9) |
1 (20) |
0 |
4 (6) |
|
Neurology | |||||||||
| Dizziness | 0 | 2 (40) | 0 | 1 (17) | 0 | 6 (27) | 1 (20) | 2 (18) | 12 (19) |
| Tremor | 0 | 0 | 0 | 0 | 0 | 6 (27) | 3 (60) | 3 (27) | 12 (19) |
| Ataxia | 0 | 0 | 0 | 0 | 0 | 3 (14) | 0 | 3 (27) | 6 (10) |
| Cerebellar syndrome | 0 | 0 | 0 | 0 | 0 | 1 (4) | 2 (40) | 2 (18) | 5 (8) |
| Balance disorder | 0 | 0 | 0 | 0 | 0 | 3 (14) | 1 (20) | 0 | 4 (6) |
| Headache | 0 | 0 | 0 | 1 (17) | 0 | 2 (9) | 0 | 1 (9) | 4 (6) |
| Muscle spasms |
0 |
0 |
0 |
0 |
1 (20) |
2 (9) |
1 (20) |
0 |
4 (6) |
|
Laboratory | |||||||||
| ALT increase | 0 | 0 | 0 | 1 (17) | 0 | 2 (9) | 1 (20) | 1 (9) | 5 (8) |
| AST increase | 0 | 0 | 0 | 1 (17) | 0 | 2 (9) | 1 (20) | 1 (9) | 5 (8) |
Abbreviations: AE=adverse events; ALT=alanine transaminase; AST=aspartate aminotransferase; pts=patients.