Table 3.
Treatment-emergent adverse events (≥10% of patients)
| Number of Patients With Specified Adverse Event |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Dose Level 1 (n=6) | Dose Level 2 (n=5) | Dose Level 3 (n=6) | Dose Level 4 (n=10) | Total (%)(n = 27) | Total (%) Grade 3/4 | |||||
| Total | Grade 3/4 | Total | Grade 3/4 | Total | Grade 3/4 | Total | Grade 3/4 | |||
| Diarrhea | 3* | 0 | 2 | 1 | 5 | 0 | 8 | 1 | 18 (67) | 2 (7) |
| Infection/febrile | ||||||||||
| neutropenia | 5 | 5 | 5 | 3 | 2 | 2 | 4 | 2 | 16 (59) | 12 (4) |
| Nausea/vomiting | 2 | 0 | 2 | 1 | 5 | 0 | 7 | 0 | 16 (59) | 1 (4) |
| Fatigue | 2 | 0 | 5 | 2 | 8 | 5* | 0 | 0 | 15 (56) | 7 (26) |
| Anorexia | 3 | 0 | 3 | 1 | 3 | 0 | 4 | 0 | 13 (48) | 1 (4) |
| Muscle weakness | 2 | 1 | 1 | 1 | 3 | 0 | 4 | 0 | 10 (37) | 2 (7) |
| Dizziness | 1 | 0 | 1 | 0 | 3 | 0 | 3 | 0 | 8 (30) | 0 (0) |
| Dyspnea | 3 | 1 | 1 | 1 | 2 | 0 | 2 | 0 | 8 (30) | 2 (7) |
| Abdominal pain | 1 | 0 | 2 | 0 | 0 | 0 | 4 | 1 | 7 (26) | 1 (4) |
| Dehydration | 1 | 0 | 1 | 0 | 2 | 0 | 3 | 0 | 7 (26) | 0 (0) |
| Rash | 1 | 0 | 1 | 0 | 2 | 0 | 3 | 0 | 7 (26) | 0 (0) |
| Hypokalemia | 1 | 1 | 1 | 0 | 2 | 0 | 2 | 1 | 6 (22) | 2 (7) |
| Insomnia | 0 | 0 | 1 | 0 | 2 | 0 | 3 | 0 | 6 (22) | 0 (0) |
| Bone pain | 0 | 0 | 2 | 0 | 2 | 0 | 1 | 0 | 5 (19) | 0 (0) |
| Limb pain | 0 | 0 | 3 | 1 | 1 | 0 | 1 | 1 | 5 (19) | 2 (7) |
| Mucositis | 2 | 0 | 2 | 1 | 1 | 0 | 0 | 0 | 5 (19) | 1 (4) |
| Rigors/chills | 2 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 5 (19) | 0 (0) |
| Sensory neuropathy | 1 | 1 | 1 | 0 | 1 | 0 | 2 | 1* | 5 (19) | 2 (7) |
| Altered mental status | 0 | 0 | 2 | 1 | 0 | 0 | 2 | 0 | 4 (15) | 1 (4) |
| Constipation | 0 | 0 | 1 | 0 | 1 | 0 | 2 | 0 | 4 (15) | 0 (0) |
| Cough | 2 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 4 (15) | 0 (0) |
| Dyspepsia | 1 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 4 (15) | 0 (0) |
| Joint pain | 1 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 4 (15) | 0 (0) |
| Cardiac arrhythmia | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 3 (11) | 0 (0) |
| Creatinine | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 3 (11) | 0 (0) |
| Dysphagia | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 3 (11) | 1 (4) |
| Edema | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 3 (11) | 0 (0) |
| Hyperbilirubinemia | 0 | 0 | 1 | 1 | 0 | 0 | 2 | 0 | 3 (11) | 1 (4) |
| Motor neuropathy | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 3 (11) | 2 (7) |
| Muscle pain | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 3 (11) | 0 (0) |
| Pleural effusion | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 3 (11) | 0 (0) |
*
Dose-limiting toxicity.