Treatment-emergent AEs regardless of attribution in patients on maintenance
| Toxicity grade CTCAE version 5.0 . | Dose level . | All N = 22 . | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DL1 42-day cycles n = 11 . | DL2 28-day cycles n = 11 . | |||||||||||
| 1 . | 2 . | 3 . | 4 . | 1 . | 2 . | 3 . | 4 . | 1 . | 2 . | 3 . | 4 . | |
| N . | N . | N . | N . | N . | N . | N . | N . | N . | N . | N . | N . | |
| Hematologic | ||||||||||||
| Anemia | 4 | - | 4 | - | 1 | 4 | 6 | - | 5 | 4 | 10 | - |
| Neutrophil count decreased | - | 2 | 1 | 7 | 1 | - | 1 | 9 | 1 | 2 | 2 | 16 |
| Platelet count decreased | 1 | 2 | 4 | 3 | - | 1 | 2 | 8 | 1 | 3 | 6 | 11 |
| WBC count decreased | - | - | 4 | 6 | - | - | - | 11 | - | - | 4 | 17 |
| Nonhematologic | ||||||||||||
| Abdominal pain | 1 | - | - | - | - | - | - | - | 1 | - | - | - |
| ALT increased | 5 | 1 | - | - | 4 | 1 | - | - | 9 | 2 | - | - |
| Alk Phos increased | 2 | - | - | - | 2 | - | - | - | 4 | - | - | - |
| Anorexia | 1 | 1 | - | - | 3 | - | - | - | 4 | 1 | - | - |
| Arthralgia | - | - | - | - | 1 | - | - | - | 1 | - | - | - |
| AST increased | 2 | - | - | - | 4 | - | - | - | 6 | - | - | - |
| Bloating | - | - | - | - | 1 | - | - | - | 1 | - | - | - |
| Blood bilirubin increased | 1 | 1 | - | - | - | - | - | - | 1 | 1 | - | - |
| Bone pain | - | - | - | - | 1 | - | - | - | 1 | - | - | - |
| Constipation | 1 | - | - | - | 4 | - | - | - | 5 | - | - | - |
| Cough | - | - | - | - | 1 | - | - | - | 1 | - | - | - |
| Creatinine increased | 3 | - | - | - | 5 | 1 | - | - | 8 | 1 | - | - |
| Diarrhea | 7 | 2 | - | - | 7 | 1 | - | - | 14 | 3 | - | - |
| Dizziness | 1 | - | - | - | 2 | - | - | - | 3 | - | - | - |
| Dysgeusia | 3 | - | - | - | 2 | - | - | - | 5 | - | - | - |
| Dyspepsia | - | - | - | - | 2 | - | - | - | 2 | - | - | - |
| Dyspnea | 1 | 1 | - | - | - | - | - | - | 1 | 1 | - | - |
| Dysuria | - | - | - | - | 1 | - | - | - | 1 | - | - | - |
| Fatigue | 2 | 3 | - | - | 9 | - | - | - | 11 | 3 | - | - |
| Febrile neutropenia | - | - | - | - | - | - | 1 | - | - | - | 1 | - |
| Headache | 1 | - | - | - | - | - | - | - | 1 | - | - | - |
| Hyperkalemia | 1 | - | - | - | 1 | 1 | - | - | 2 | 1 | - | - |
| Hyperuricemia | 1 | - | - | - | 1 | - | - | - | 2 | - | - | - |
| Hypocalcemia | - | - | - | - | 2 | 1 | - | - | 2 | 1 | - | - |
| Hypomagnesemia | 1 | 1 | - | - | 3 | - | - | - | 4 | 1 | - | - |
| Lip pain | 1 | - | - | - | - | - | - | - | 1 | - | - | - |
| Mucositis oral | - | - | - | - | 3 | - | - | - | 3 | - | - | - |
| Nail discoloration | - | - | - | - | 1 | - | - | - | 1 | - | - | - |
| Nausea | 3 | 3 | - | - | 7 | 3 | - | - | 10 | 6 | - | - |
| Parainfluenza infection | - | - | - | - | 1 | - | - | - | 1 | - | - | - |
| Peripheral sensory neuropathy | - | - | - | - | 1 | - | - | - | 1 | - | - | - |
| Pruritus | 1 | - | - | - | 1 | - | - | - | 2 | - | - | - |
| Rash maculopapular | 1 | 1 | - | - | - | - | - | - | 1 | 1 | - | - |
| Urinary frequency | - | - | - | - | 1 | - | - | - | 1 | - | - | - |
| Vomiting | - | 1 | - | - | 1 | - | - | - | 1 | 1 | - | - |
| Weight loss | - | - | - | - | 1 | - | - | - | 1 | - | - | - |
| Toxicity grade CTCAE version 5.0 . | Dose level . | All N = 22 . | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DL1 42-day cycles n = 11 . | DL2 28-day cycles n = 11 . | |||||||||||
| 1 . | 2 . | 3 . | 4 . | 1 . | 2 . | 3 . | 4 . | 1 . | 2 . | 3 . | 4 . | |
| N . | N . | N . | N . | N . | N . | N . | N . | N . | N . | N . | N . | |
| Hematologic | ||||||||||||
| Anemia | 4 | - | 4 | - | 1 | 4 | 6 | - | 5 | 4 | 10 | - |
| Neutrophil count decreased | - | 2 | 1 | 7 | 1 | - | 1 | 9 | 1 | 2 | 2 | 16 |
| Platelet count decreased | 1 | 2 | 4 | 3 | - | 1 | 2 | 8 | 1 | 3 | 6 | 11 |
| WBC count decreased | - | - | 4 | 6 | - | - | - | 11 | - | - | 4 | 17 |
| Nonhematologic | ||||||||||||
| Abdominal pain | 1 | - | - | - | - | - | - | - | 1 | - | - | - |
| ALT increased | 5 | 1 | - | - | 4 | 1 | - | - | 9 | 2 | - | - |
| Alk Phos increased | 2 | - | - | - | 2 | - | - | - | 4 | - | - | - |
| Anorexia | 1 | 1 | - | - | 3 | - | - | - | 4 | 1 | - | - |
| Arthralgia | - | - | - | - | 1 | - | - | - | 1 | - | - | - |
| AST increased | 2 | - | - | - | 4 | - | - | - | 6 | - | - | - |
| Bloating | - | - | - | - | 1 | - | - | - | 1 | - | - | - |
| Blood bilirubin increased | 1 | 1 | - | - | - | - | - | - | 1 | 1 | - | - |
| Bone pain | - | - | - | - | 1 | - | - | - | 1 | - | - | - |
| Constipation | 1 | - | - | - | 4 | - | - | - | 5 | - | - | - |
| Cough | - | - | - | - | 1 | - | - | - | 1 | - | - | - |
| Creatinine increased | 3 | - | - | - | 5 | 1 | - | - | 8 | 1 | - | - |
| Diarrhea | 7 | 2 | - | - | 7 | 1 | - | - | 14 | 3 | - | - |
| Dizziness | 1 | - | - | - | 2 | - | - | - | 3 | - | - | - |
| Dysgeusia | 3 | - | - | - | 2 | - | - | - | 5 | - | - | - |
| Dyspepsia | - | - | - | - | 2 | - | - | - | 2 | - | - | - |
| Dyspnea | 1 | 1 | - | - | - | - | - | - | 1 | 1 | - | - |
| Dysuria | - | - | - | - | 1 | - | - | - | 1 | - | - | - |
| Fatigue | 2 | 3 | - | - | 9 | - | - | - | 11 | 3 | - | - |
| Febrile neutropenia | - | - | - | - | - | - | 1 | - | - | - | 1 | - |
| Headache | 1 | - | - | - | - | - | - | - | 1 | - | - | - |
| Hyperkalemia | 1 | - | - | - | 1 | 1 | - | - | 2 | 1 | - | - |
| Hyperuricemia | 1 | - | - | - | 1 | - | - | - | 2 | - | - | - |
| Hypocalcemia | - | - | - | - | 2 | 1 | - | - | 2 | 1 | - | - |
| Hypomagnesemia | 1 | 1 | - | - | 3 | - | - | - | 4 | 1 | - | - |
| Lip pain | 1 | - | - | - | - | - | - | - | 1 | - | - | - |
| Mucositis oral | - | - | - | - | 3 | - | - | - | 3 | - | - | - |
| Nail discoloration | - | - | - | - | 1 | - | - | - | 1 | - | - | - |
| Nausea | 3 | 3 | - | - | 7 | 3 | - | - | 10 | 6 | - | - |
| Parainfluenza infection | - | - | - | - | 1 | - | - | - | 1 | - | - | - |
| Peripheral sensory neuropathy | - | - | - | - | 1 | - | - | - | 1 | - | - | - |
| Pruritus | 1 | - | - | - | 1 | - | - | - | 2 | - | - | - |
| Rash maculopapular | 1 | 1 | - | - | - | - | - | - | 1 | 1 | - | - |
| Urinary frequency | - | - | - | - | 1 | - | - | - | 1 | - | - | - |
| Vomiting | - | 1 | - | - | 1 | - | - | - | 1 | 1 | - | - |
| Weight loss | - | - | - | - | 1 | - | - | - | 1 | - | - | - |
ALT, alanine aminotransferase; Alk Phos, alkaline phosphatase; AST, aspartate aminotransferase; CTCAE, Common Terminology Criteria for Adverse Events; WBC, white blood cell.