Table 5.

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)	–

–, 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.