Safety summary.
| . | E7389-LF Q3W . | E7389-LF Q2W . | |||||
|---|---|---|---|---|---|---|---|
| Parameters . | 1.0 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) | 0 | 0 | 1 (8.3) | 1 (33.3) | 0 | 1 (11.1) |
| Grade 2 | 1 (33.3) | 0 | 1 (16.7) | 2 (16.7) | 0 | 0 | 0 |
| Grade 3 | 1 (33.3) | 0 | 0 | 1 (8.3) | 2 (66.7) | 2 (33.3) | 4 (44.4) |
| Grade 4 | 0 | 3 (100) | 4 (66.7) | 7 (58.3) | 0 | 4 (66.7) | 4 (44.4) |
| SAEs, n (%)c | 0 | 1 (33.3) | 2 (33.3) | 3 (25.0) | 0 | 1 (16.7) | 1 (11.1) |
| Upper limb fracture | 0 | 0 | 1 (16.7) | 1 (8.3) | 0 | 0 | 0 |
| Hematuria | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (11.1) |
| Hemoptysis | 0 | 1 (33.3) | 0 | 1 (8.3) | 0 | 0 | 0 |
| Respiratory failure | 0 | 0 | 1 (16.7) | 1 (8.3) | 0 | 0 | 0 |
| 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) | 0 | 0 | 1 (8.3) | 0 | 0 | 0 |
| Grade 2 | 1 (33.3) | 0 | 1 (16.7) | 2 (16.7) | 1 (33.3) | 0 | 1 (11.1) |
| Grade 3 | 1 (33.3) | 0 | 0 | 1 (8.3) | 1 (33.3) | 2 (33.3) | 3 (33.3) |
| Grade 4 | 0 | 3 (100) | 5 (83.3) | 8 (66.7) | 0 | 4 (66.7) | 4 (44.4) |
| . | E7389-LF Q3W . | E7389-LF Q2W . | |||||
|---|---|---|---|---|---|---|---|
| Parameters . | 1.0 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) | 0 | 0 | 1 (8.3) | 1 (33.3) | 0 | 1 (11.1) |
| Grade 2 | 1 (33.3) | 0 | 1 (16.7) | 2 (16.7) | 0 | 0 | 0 |
| Grade 3 | 1 (33.3) | 0 | 0 | 1 (8.3) | 2 (66.7) | 2 (33.3) | 4 (44.4) |
| Grade 4 | 0 | 3 (100) | 4 (66.7) | 7 (58.3) | 0 | 4 (66.7) | 4 (44.4) |
| SAEs, n (%)c | 0 | 1 (33.3) | 2 (33.3) | 3 (25.0) | 0 | 1 (16.7) | 1 (11.1) |
| Upper limb fracture | 0 | 0 | 1 (16.7) | 1 (8.3) | 0 | 0 | 0 |
| Hematuria | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (11.1) |
| Hemoptysis | 0 | 1 (33.3) | 0 | 1 (8.3) | 0 | 0 | 0 |
| Respiratory failure | 0 | 0 | 1 (16.7) | 1 (8.3) | 0 | 0 | 0 |
| 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) | 0 | 0 | 1 (8.3) | 0 | 0 | 0 |
| Grade 2 | 1 (33.3) | 0 | 1 (16.7) | 2 (16.7) | 1 (33.3) | 0 | 1 (11.1) |
| Grade 3 | 1 (33.3) | 0 | 0 | 1 (8.3) | 1 (33.3) | 2 (33.3) | 3 (33.3) |
| Grade 4 | 0 | 3 (100) | 5 (83.3) | 8 (66.7) | 0 | 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.