Table 2.
Adverse events
| Event | Grade 1/2 |
Grade 3/4 |
||||||
|---|---|---|---|---|---|---|---|---|
| Cohort 1 (n = 3) |
Cohort 2 (n = 3) |
Cohort 3/3E (n = 6) |
Cohort 4 (n = 3) |
Cohort 1 (n = 3) |
Cohort 2 (n = 3) |
Cohort 3/3E (n = 6) |
Cohort 4 (n = 3) |
|
| Neutropeniaa | 1 (33%) | 2 (67%) | 2 (33%) | 1 (33%)c | 1 (17%)d | 2 (67%)e | ||
| Hypophosphatemia | 1 (33%) | 1 (17%) | 1 (17%)f | 2 (67%)f | ||||
| AST elevation | 1 (33%) | 0 | 1 (17%) | 1 (33%) | 1 (33%)f | |||
| Fatigue | 3 (100%) | 3 (100%) | 6 (100%) | 3 (100%) | ||||
| Injection site reaction | 3 (100%) | 3 (100%) | 6 (100%) | 3 (100%) | ||||
| Flu-like symptoms | 1 (33%) | 3 (100%) | 6 (100%) | 3 (100%) | ||||
| Hyperglycemiab | 1 (33%) | 3 (100%) | 5 (83%) | 3 (100%) | ||||
| Thrombocytopeniaa | 1 (33%) | 3 (100%) | 5 (83%) | 2 (67%) | ||||
| Hyperuricemia | 2 (67%) | 2 (67%) | 4 (67%) | 1 (33%) | ||||
| Sweating | 2 (67%) | 4 (67%) | 2 (67%) | |||||
| Hypocalcemia | 1 (33%) | 2 (67%) | 3 (50%) | 1 (33%) | ||||
| Nausea | 1 (33%) | 1 (17%) | 2 (67%) | |||||
| ALT elevation | 2 (33%) | 2 (67%) | ||||||
| Constipation | 2 (33%) | 1 (33%) | ||||||
| Insomnia | 1 (17%) | 2 (67%) | ||||||
| Anorexia | 2 (33%) | |||||||
| Arthritis (nonseptic) | 1 (33%) | 1 (17%) | ||||||
| Diarrhea | 1 (33%) | 1 (33%) | ||||||
| Hypotension | 1 (33%) | 1 (33%) | ||||||
| Total events/patient | 5.3 | 8.6 | 8.6 | 9.3 | 0 | 0.3 | 0.3 | 1.7 |
| Total events | 16 | 26 | 52 | 28 | 0 | 1 | 2 | 5 |
a
Based on IWCLL 2008 criteria.
b
Patient with history of insulin-dependent diabetes mellitus (ID-DM) was not included.
c
Patient presented neutropenia grade 3 (not considered DLT).
d
Patient presented neutropenia grade 4 that lasted for 5 days (not considered DLT).
e
Patients presented neutropenia grade 3 (not considered DLTs).
f
Adverse events considered DLTs.