Treatment-related AEs reported in >15% of patients in the treated population (N = 64), plus all other events reported at grade 3-5 severity
| . | AEs, n (%) . | |||
|---|---|---|---|---|
| All grades . | Grade 3 . | Grade 4 . | Grade 5 . | |
| Neuropathy, sensory* | 34† (53) | – | – | – |
| Fatigue | 32 (50) | 3 (5) | – | – |
| Neutropenia | 27 (42) | 18 (28) | 1 (2) | – |
| Diarrhea without prior colostomy | 26 (41) | 2 (3) | – | – |
| Muscle pain | 25 (39) | – | – | – |
| Hyperglycemia | 24 (38) | 6 (9) | – | – |
| Edema, limb | 22 (34) | 2 (3) | – | – |
| Thrombocytopenia | 21 (33) | 8 (13) | 6 (9) | – |
| Constipation | 19 (30) | – | – | – |
| Insomnia | 18 (28) | – | – | – |
| Pain in extremity | 15 (23) | 1 (2) | – | – |
| Anemia | 15 (23) | 1 (2) | – | – |
| Nausea | 15 (23) | – | – | – |
| Leukopenia | 11 (17) | 6 (9) | – | – |
| Neuropathic pain | 11 (17) | – | – | – |
| Neuropathy, motor | 9 (14) | 2 (3) | – | – |
| Rash/desquamation | 9 (14) | 1 (2) | – | – |
| Dizziness | 9 (14) | 1 (2) | – | – |
| Lymphopenia | 7 (11) | 7 (11) | – | – |
| Hyponatremia | 7 (11) | 5 (8) | – | – |
| Fever without neutropenia | 7 (11) | 1 (2) | – | – |
| Hypophosphatemia | 6 (9) | 5 (8) | 1 (2) | – |
| Pulmonary/upper respiratory, other | 4 (6) | 2 (3) | 1 (2) | 1 (2) |
| Atrial fibrillation | 3 (5) | 2 (3) | – | – |
| Hypotension | 3 (5) | 1 (2) | – | – |
| Lung infection with grade 0-2 neutropenia | 2 (3) | 1 (2) | – | – |
| Confusion | 2 (3) | – | 1 (2) | – |
| Apnea | 1 (2) | 1 (2) | – | – |
| Psychosis | 1 (2) | – | 1 (2) | – |
| . | AEs, n (%) . | |||
|---|---|---|---|---|
| All grades . | Grade 3 . | Grade 4 . | Grade 5 . | |
| Neuropathy, sensory* | 34† (53) | – | – | – |
| Fatigue | 32 (50) | 3 (5) | – | – |
| Neutropenia | 27 (42) | 18 (28) | 1 (2) | – |
| Diarrhea without prior colostomy | 26 (41) | 2 (3) | – | – |
| Muscle pain | 25 (39) | – | – | – |
| Hyperglycemia | 24 (38) | 6 (9) | – | – |
| Edema, limb | 22 (34) | 2 (3) | – | – |
| Thrombocytopenia | 21 (33) | 8 (13) | 6 (9) | – |
| Constipation | 19 (30) | – | – | – |
| Insomnia | 18 (28) | – | – | – |
| Pain in extremity | 15 (23) | 1 (2) | – | – |
| Anemia | 15 (23) | 1 (2) | – | – |
| Nausea | 15 (23) | – | – | – |
| Leukopenia | 11 (17) | 6 (9) | – | – |
| Neuropathic pain | 11 (17) | – | – | – |
| Neuropathy, motor | 9 (14) | 2 (3) | – | – |
| Rash/desquamation | 9 (14) | 1 (2) | – | – |
| Dizziness | 9 (14) | 1 (2) | – | – |
| Lymphopenia | 7 (11) | 7 (11) | – | – |
| Hyponatremia | 7 (11) | 5 (8) | – | – |
| Fever without neutropenia | 7 (11) | 1 (2) | – | – |
| Hypophosphatemia | 6 (9) | 5 (8) | 1 (2) | – |
| Pulmonary/upper respiratory, other | 4 (6) | 2 (3) | 1 (2) | 1 (2) |
| Atrial fibrillation | 3 (5) | 2 (3) | – | – |
| Hypotension | 3 (5) | 1 (2) | – | – |
| Lung infection with grade 0-2 neutropenia | 2 (3) | 1 (2) | – | – |
| Confusion | 2 (3) | – | 1 (2) | – |
| Apnea | 1 (2) | 1 (2) | – | – |
| Psychosis | 1 (2) | – | 1 (2) | – |
–, event did not occur at this grade.
22 cases were grade 1, 12 cases were grade 2.
PN was reported in 28 of 41 patients who had no PN at baseline (22 had grade 1, 6 grade 2) and 6 of 23 patients with grade 1 PN at baseline (increasing to grade 2 during the study). Sensory PN was manageable and 16 of the 34 patients had improvement or resolution of their PN, including resolution to grade 0 in 10 patients who had no PN at baseline and in 1 patient with grade 1 PN at baseline. However, 2 patients with grade 1 events that resolved to grade 0 and 2 patients with grade 2 events that improved to grade 1 subsequently experienced another PN event or worsening to grade 2, respectively.