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Table 2.

Safety summary.

E7389-LF Q3WE7389-LF Q2W
Parameters1.0 mg/m2 (n = 3)1.5 mg/m2 (n = 3)2.0 mg/m2 (n = 6)Total (n = 12)1.0 mg/m2 (n = 3)1.5 mg/m2 (n = 6)Total (n = 9)
Median duration of treatment, monthsa 1.38 1.38 3.12 2.78 2.83 5.59 2.89 
 Range 1.4–9.7 1.4–13.2 1.4–25.5 1.4–25.5 1.8–15.6 0.9–13.8 0.9–15.6 
Any TEAEs, n (%) 3 (100) 3 (100) 6 (100)b 12 (100) 3 (100) 6 (100) 9 (100) 
 Grade 1 1 (33.3) 1 (8.3) 1 (33.3) 1 (11.1) 
 Grade 2 1 (33.3) 1 (16.7) 2 (16.7) 
 Grade 3 1 (33.3) 1 (8.3) 2 (66.7) 2 (33.3) 4 (44.4) 
 Grade 4 3 (100) 4 (66.7) 7 (58.3) 4 (66.7) 4 (44.4) 
SAEs, n (%)c 1 (33.3) 2 (33.3) 3 (25.0) 1 (16.7) 1 (11.1) 
 Upper limb fracture 1 (16.7) 1 (8.3) 
 Hematuria 1 (16.7) 1 (11.1) 
 Hemoptysis 1 (33.3) 1 (8.3) 
 Respiratory failure 1 (16.7) 1 (8.3) 
Treatment-related TEAEs, n (%) 3 (100) 3 (100) 6 (100) 12 (100) 2 (66.7) 6 (100) 8 (88.9) 
 Grade 1 1 (33.3) 1 (8.3) 
 Grade 2 1 (33.3) 1 (16.7) 2 (16.7) 1 (33.3) 1 (11.1) 
 Grade 3 1 (33.3) 1 (8.3) 1 (33.3) 2 (33.3) 3 (33.3) 
 Grade 4 3 (100) 5 (83.3) 8 (66.7) 4 (66.7) 4 (44.4) 
E7389-LF Q3WE7389-LF Q2W
Parameters1.0 mg/m2 (n = 3)1.5 mg/m2 (n = 3)2.0 mg/m2 (n = 6)Total (n = 12)1.0 mg/m2 (n = 3)1.5 mg/m2 (n = 6)Total (n = 9)
Median duration of treatment, monthsa 1.38 1.38 3.12 2.78 2.83 5.59 2.89 
 Range 1.4–9.7 1.4–13.2 1.4–25.5 1.4–25.5 1.8–15.6 0.9–13.8 0.9–15.6 
Any TEAEs, n (%) 3 (100) 3 (100) 6 (100)b 12 (100) 3 (100) 6 (100) 9 (100) 
 Grade 1 1 (33.3) 1 (8.3) 1 (33.3) 1 (11.1) 
 Grade 2 1 (33.3) 1 (16.7) 2 (16.7) 
 Grade 3 1 (33.3) 1 (8.3) 2 (66.7) 2 (33.3) 4 (44.4) 
 Grade 4 3 (100) 4 (66.7) 7 (58.3) 4 (66.7) 4 (44.4) 
SAEs, n (%)c 1 (33.3) 2 (33.3) 3 (25.0) 1 (16.7) 1 (11.1) 
 Upper limb fracture 1 (16.7) 1 (8.3) 
 Hematuria 1 (16.7) 1 (11.1) 
 Hemoptysis 1 (33.3) 1 (8.3) 
 Respiratory failure 1 (16.7) 1 (8.3) 
Treatment-related TEAEs, n (%) 3 (100) 3 (100) 6 (100) 12 (100) 2 (66.7) 6 (100) 8 (88.9) 
 Grade 1 1 (33.3) 1 (8.3) 
 Grade 2 1 (33.3) 1 (16.7) 2 (16.7) 1 (33.3) 1 (11.1) 
 Grade 3 1 (33.3) 1 (8.3) 1 (33.3) 2 (33.3) 3 (33.3) 
 Grade 4 3 (100) 5 (83.3) 8 (66.7) 4 (66.7) 4 (44.4) 

Note: Percentages are based on the total number of patients in the safety analysis set within the relevant treatment group. A patient with two or more adverse events in the same preferred term was counted only once for that preferred term. Adverse-event terms were coded using the Medical Dictionary for Regulatory Activities version 23.1. Adverse events were graded using CTCAE version 4.03. Treatment-related TEAEs include TEAEs with missing causality and TEAEs that were considered by the investigator to have a reasonable possibility of relation to the study drug.

Abbreviations: CTCAE, Common Terminology Criteria for Adverse Events; E7389-LF, eribulin liposomal formulation; Q2W, every 2 weeks; Q3W, every 3 weeks; SAE, serious adverse event; TEAE, treatment-emergent adverse event.

aDuration of Q3W treatment = (date of day 1 of final cycle + 21 – date of first dose)/(365.25/12). Duration of Q2W treatment = (date of day 1 of final cycle + 28 – date of first dose)/(365.25/12).

bOne grade 5 TEAE of respiratory failure was also reported.

cAll SAEs were unrelated to study drug except for hemoptysis, and all were rated as grade 3 except for respiratory failure, which was grade 5.

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