Table 3a. Incidence of treatment emergent Grade 3 or 4 haematological and nonhaematological toxicities for all cycles observed.
| Level 1 | Level 2 | Level 3 | Level 4 | Level 5 | Total | |
|---|---|---|---|---|---|---|
| Cohort | 1 | 2 | 3 | 4 | 5 | |
| n | n | n | n | n | n (%) | |
| Total no. of subjects | 4 | 11 | 6 | 7 | 3 | 31 |
| No. of subjects with Grade 3–4 toxicity | 2 | 11 | 4 | 7 | 3 | 27 (87) |
| Haematological | ||||||
| Neutropeniaa | 1 | 3 | 2 | 4 | 1 | 11 (35) |
| Anaemia | — | 3 | — | 1 | — | 4 (13) |
| Thrombocytopenia | — | 1 | 2 | 1 | 1 | 5 (16) |
| Nonhaematological | ||||||
| Nausea | — | 3 | 2 | 2 | 1 | 8 (26) |
| Vomiting | — | 3 | 2 | 2 | — | 7 (23) |
| Constipation | — | — | — | 2 | — | 2 (6) |
| Fatigue | — | 2 | 1 | 1 | 2 | 6 (19) |
| Hypokalemia | — | — | — | 3 | — | 3 (10) |
| Thrombophlebitis | — | 2 | — | — | — | 2 (6) |
| Pulmonary embolism | 1 | — | — | — | — | 1 (3) |
| ALAT elevation | — | 1 | — | — | — | 1 (3) |
a
One patient treated at dose level 4 developed febrile neutropenia.