Table 2.
Dose-limiting toxicities per dose level
| |
Dose level |
|
|||||
|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | Total | ||||
| Number of patients |
4 (100%) |
13 (100%) |
7 (100%) |
24 (100%) |
|||
| Any DLTs? |
|
|
|
|
|||
| No |
3 (75%) |
12 (92%) |
2 (29%) |
17 (71%) |
|||
| Yes |
1 (25%) |
1 (8%) |
5 (71%) |
7 (29%) |
|||
| If yes: |
|
|
|
|
|||
| CTC-Grade |
III |
IV |
III |
IV |
III |
IV |
|
| Non-haematological toxicity grade ≥ 3: |
|
|
|
|
|
|
6 (25%) |
| - Dehydration, syncope |
1 |
|
|
|
|
|
|
| - Heartburn/dyspepsia |
|
|
|
|
|
1 |
|
| - Fatigue |
|
|
|
|
2 |
|
|
| - Diarrhea |
|
|
|
|
1 |
|
|
| - Infection |
|
|
|
|
1 |
|
|
| Haematological toxicity: |
|
|
|
|
|
|
1 (4%) |
| - Thrombocytpenia | 1 | ||||||
DLT, dose limiting toxicity.