Safety and tolerability of etirinotecan pegol in advanced breast cancer: analysis of the randomized, phase 3 BEACON trial

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Table 6 Safety profiles in populations of interest

Adverse event, n (%)	Etirinotecan pegol (n = 425) (%)	Eribulin-treated patients (n = 164) (%)
Safety among eribulin-treated patients
Neutropenia^a, overall	26.1	39.0
Neutropenia^a, grade 3 or higher	9.6	32.3
Neuropathy^b, overall	7.8	32.3
Neuropathy^b, grade 3 or higher	0.5	4.3

Grade 3 or higher TEAE, n (%)^c	Etirinotecan pegol (n = 34)	TPC (n = 27)
Safety among patients with history of brain metastases
At least one TEAE	17 (50.0)	19 (70.4)
Nausea	2 (5.9)	0
Pleural effusion	2 (5.9)	0
Syncope	2 (5.9)	0

Adverse event, n (%)	Etirinotecan pegol (n = 425) (%)	Eribulin-treated patients (n = 164) (%)
Safety among eribulin-treated patients
Diarrhea	2 (5.9)	1 (3.7)
Neutropenia	5 (14.7)	9 (33.3)
Hyponatremia	0	2 (7.4)

TEAE treatment-emergent adverse event
^aComposite term encompassing neutropenia, febrile neutropenia, neutropenic sepsis, and neutrophil count decreased
^bComposite term encompassing acute polyneuropathy, critical illness polyneuropathy, mononeuropathy, mononeuropathy multiplex, multifocal motor neuropathy, neuronal neuropathy, neuropathy peripheral, peripheral motor neuropathy, peripheral sensorimotor neuropathy, peripheral sensory neuropathy, polyneuropathy, polyneuropathy idiopathic progressive, and polyneuropathy in malignant disease
^cAdverse events reported in 5 % of more of patients in at least one treatment arm