Maximum severity of adverse events (regardless of attribution)
| Body system/toxicity* . | 2-mg cohort, % . | 4-mg cohort, % . | ||||||
|---|---|---|---|---|---|---|---|---|
| Group 1 . | Group 2 . | Group 3 . | Group 4 . | Group 1 . | Group 2 . | Group 3 . | Group 4 . | |
| Hematology | ||||||||
| Anemia | 26 | 49 | 26 | 0 | 37 | 37 | 23 | 3 |
| Leukopenia | 11 | 31 | 31 | 9 | 9 | 23 | 54 | 6 |
| Lymphocyte count decreased | 0 | 3 | 26 | 6 | 0 | 6 | 34 | 3 |
| Neutrophil count decreased | 11 | 23 | 40 | 11 | 6 | 20 | 34 | 31 |
| Platelet count decreased | 34 | 23 | 29 | 3 | 40 | 14 | 14 | 17 |
| Infection/febrile neutropenia | ||||||||
| Febrile neutropenia | 0 | 0 | 0 | 0 | 0 | 0 | 11 | 0 |
| Pneumonia | 0 | 0 | 31 | 0 | 0 | 3 | 3 | 0 |
| Upper respiratory infection | 0 | 0 | 6 | 0 | 0 | 0 | 0 | 0 |
| Metabolic/laboratory | ||||||||
| Hyperglycemia | 0 | 3 | 9 | 0 | 0 | 6 | 3 | 0 |
| Hypercalcemia | 0 | 0 | 3 | 3 | 0 | 0 | 0 | 3 |
| Musculoskeletal | ||||||||
| Fracture | 0 | 0 | 6 | 0 | 0 | 0 | 6 | 0 |
| Neurology | ||||||||
| Agitation | 0 | 6 | 3 | 0 | 0 | 0 | 0 | 0 |
| Anxiety | 0 | 6 | 0 | 0 | 0 | 3 | 0 | 0 |
| Confusion | 0 | 3 | 3 | 0 | 0 | 0 | 0 | 0 |
| Dizziness | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 |
| Depression | 0 | 3 | 0 | 0 | 0 | 9 | 0 | 0 |
| Insomnia | 0 | 6 | 6 | 0 | 0 | 3 | 0 | 0 |
| Peripheral sensory neuropathy | 51 | 29 | 0 | 0 | 69 | 17 | 3 | 0 |
| Tremor | 0 | 6 | 0 | 0 | 0 | 0 | 3 | 0 |
| Pain | ||||||||
| Back pain | 0 | 0 | 3 | 0 | 0 | 0 | 9 | 0 |
| Pulmonary | ||||||||
| Dyspnea | 0 | 3 | 3 | 0 | 0 | 3 | 3 | 0 |
| Renal/genitourinary | ||||||||
| Renal failure | 0 | 0 | 11 | 0 | 0 | 0 | 0 | 0 |
| Cardiovascular | ||||||||
| Atrial fibrillation | 0 | 3 | 9 | 0 | 0 | 0 | 0 | 0 |
| Thrombosis | 0 | 3 | 3 | 0 | 0 | 0 | 3 | 0 |
| Dermatology/skin | ||||||||
| Rash | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 |
| Constitutional symptoms | ||||||||
| Fatigue | 11 | 69 | 9 | 0 | 31 | 51 | 9 | 0 |
| Sweating | 0 | 0 | 0 | 0 | 0 | 6 | 0 | 0 |
| Gastrointestinal | ||||||||
| Anorexia | 26 | 3 | 0 | 0 | 26 | 9 | 0 | 0 |
| Diarrhea | 26 | 6 | 0 | 0 | 14 | 9 | 0 | 0 |
| Dyspepsia | 0 | 0 | 0 | 0 | 0 | 6 | 0 | 0 |
| Nausea | 23 | 9 | 0 | 0 | 11 | 6 | 0 | 0 |
| Vomiting | 20 | 0 | 0 | 0 | 9 | 3 | 0 | 0 |
| Body system/toxicity* . | 2-mg cohort, % . | 4-mg cohort, % . | ||||||
|---|---|---|---|---|---|---|---|---|
| Group 1 . | Group 2 . | Group 3 . | Group 4 . | Group 1 . | Group 2 . | Group 3 . | Group 4 . | |
| Hematology | ||||||||
| Anemia | 26 | 49 | 26 | 0 | 37 | 37 | 23 | 3 |
| Leukopenia | 11 | 31 | 31 | 9 | 9 | 23 | 54 | 6 |
| Lymphocyte count decreased | 0 | 3 | 26 | 6 | 0 | 6 | 34 | 3 |
| Neutrophil count decreased | 11 | 23 | 40 | 11 | 6 | 20 | 34 | 31 |
| Platelet count decreased | 34 | 23 | 29 | 3 | 40 | 14 | 14 | 17 |
| Infection/febrile neutropenia | ||||||||
| Febrile neutropenia | 0 | 0 | 0 | 0 | 0 | 0 | 11 | 0 |
| Pneumonia | 0 | 0 | 31 | 0 | 0 | 3 | 3 | 0 |
| Upper respiratory infection | 0 | 0 | 6 | 0 | 0 | 0 | 0 | 0 |
| Metabolic/laboratory | ||||||||
| Hyperglycemia | 0 | 3 | 9 | 0 | 0 | 6 | 3 | 0 |
| Hypercalcemia | 0 | 0 | 3 | 3 | 0 | 0 | 0 | 3 |
| Musculoskeletal | ||||||||
| Fracture | 0 | 0 | 6 | 0 | 0 | 0 | 6 | 0 |
| Neurology | ||||||||
| Agitation | 0 | 6 | 3 | 0 | 0 | 0 | 0 | 0 |
| Anxiety | 0 | 6 | 0 | 0 | 0 | 3 | 0 | 0 |
| Confusion | 0 | 3 | 3 | 0 | 0 | 0 | 0 | 0 |
| Dizziness | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 |
| Depression | 0 | 3 | 0 | 0 | 0 | 9 | 0 | 0 |
| Insomnia | 0 | 6 | 6 | 0 | 0 | 3 | 0 | 0 |
| Peripheral sensory neuropathy | 51 | 29 | 0 | 0 | 69 | 17 | 3 | 0 |
| Tremor | 0 | 6 | 0 | 0 | 0 | 0 | 3 | 0 |
| Pain | ||||||||
| Back pain | 0 | 0 | 3 | 0 | 0 | 0 | 9 | 0 |
| Pulmonary | ||||||||
| Dyspnea | 0 | 3 | 3 | 0 | 0 | 3 | 3 | 0 |
| Renal/genitourinary | ||||||||
| Renal failure | 0 | 0 | 11 | 0 | 0 | 0 | 0 | 0 |
| Cardiovascular | ||||||||
| Atrial fibrillation | 0 | 3 | 9 | 0 | 0 | 0 | 0 | 0 |
| Thrombosis | 0 | 3 | 3 | 0 | 0 | 0 | 3 | 0 |
| Dermatology/skin | ||||||||
| Rash | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 |
| Constitutional symptoms | ||||||||
| Fatigue | 11 | 69 | 9 | 0 | 31 | 51 | 9 | 0 |
| Sweating | 0 | 0 | 0 | 0 | 0 | 6 | 0 | 0 |
| Gastrointestinal | ||||||||
| Anorexia | 26 | 3 | 0 | 0 | 26 | 9 | 0 | 0 |
| Diarrhea | 26 | 6 | 0 | 0 | 14 | 9 | 0 | 0 |
| Dyspepsia | 0 | 0 | 0 | 0 | 0 | 6 | 0 | 0 |
| Nausea | 23 | 9 | 0 | 0 | 11 | 6 | 0 | 0 |
| Vomiting | 20 | 0 | 0 | 0 | 9 | 3 | 0 | 0 |
Common Terminology Criteria for Adverse Events Version 3.0.