Table 2. Treatment-emergent grade 3 or 4 adverse events in ⩾10% of patients.
|
Phase I
|
Phase II
|
|||
|---|---|---|---|---|
| Event | Cohort 1 (n=3) n (%) | Cohort 2a (n=15) n (%) | Total (N=18) n (%) | Total (N=83) n (%) |
| Blood/bone marrow | ||||
| Neutrophils | 0 | 2 (13) | 2 (11) | 30 (36) |
| Leukocytes | 0 | 2 (13) | 2 (11) | 6 (7) |
| Platelets | 0 | 0 | 0 | 18 (22) |
| Cardiac | ||||
| Hypertension | 2 (67) | 1 (7) | 3 (17) | 2 (2) |
| Fatigue | 0 | 4 (27) | 4 (22) | 7 (8) |
| Infection | ||||
| Febrile neutropenia | 0 | 3 (20) | 3 (17) | 1 (1) |
| Metabolic/laboratory any event | ||||
| Lipase | 1 (33) | 2 (13) | 3 (17) | 2 (2) |
| Neurology | ||||
| Seizure | 1 (33) | 0 | 1 (6) | NR |
| Pain | ||||
| Tumour pain | 0 | 2 (13) | 2 (11) | 0 |
| Other | 0 | 2 (13) | 2 (11) | NR |
| Renal failure | 0 | 2 (13) | 2 (11) | NR |
Abbreviation: NR=not reported.
a
Includes cohort 2 and expansion cohort 2.