Table 2.
Phase I | Phase II | ||||
---|---|---|---|---|---|
Dose level 1 |
Dose level 2 |
Dose level 3 |
RS | CLL | |
No. of patients (%) | 3 (25) | 6 (50) | 3 (25) | 30 (33) | 60 (67) |
Hematologic | |||||
Neutropenia | 2 (67) | 5 (83) | 3 (100) | 25 (89) | 46 (77) |
Anemia | 1 (33) | 3 (50) | 1 (33) | 15 (50) | 29 (48) |
Thrombocytopenia | 3 (100) | 6 (100) | 3 (100) | 23 (77) | 49 (82) |
Non-hematologic | |||||
Neutropenic fever | 2(33) | 1(33) | 6 (20) | 6 (10) | |
Non-neutropenic fever | 3 (5) | ||||
Dehydration | 1 (3) | 6 (10) | |||
Fatigue | 1 (2) | ||||
Infection | 3(50) | 1(33) | 5 (17) | 12 (20) |
|
Diarrhea | 1(17) | 1 (3) | 2 (3) | ||
Nausea/vomiting | 2 (6) | 4 (6) | |||
Hemorrhage | 1 (3) | 2 (3) | |||
Dyspnea | 3 (9) | ||||
ARDS | 1 (2) | ||||
Airway obstruction | 1 (3) | ||||
Atrial fibrillation | 1 (3) | ||||
Hypotension | 1 (3) | 1 (2) | |||
Acute renal failure | 1 (3) | ||||
Altered mental status | 1 (3) | ||||
Syncope | 1 (3) | ||||
Tumor lysis syndrome | 2 (3) | ||||
Multiorgan failure | 1 (2) | ||||
Hyperglycemia | 1 (2) |
Abbreviations: ARDS = Adult Respiratory Distress Syndrome