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Table 5 Descriptive Data for LVEF

From: A randomized, double-blind, phase III, non-inferiority clinical trial comparing the efficacy and safety of TA4415V (a proposed Trastuzumab biosimilar) and Herceptin (Trastuzumab reference product) in HER2-positive early-stage breast Cancer patients

Visit and Statistic

TA4415V

Reference trastuzumab

Baseline

 

Change from Baseline

 

Change from Baseline

 Mean (95% CI)

57.94 (56.91,59.03)

 

56.92 (55.42,58.41)

 

 Median (Range)

60 (55,60)

 

55 (55,60)

 

Visit 5

 Mean (95% CI)

55.58 (56.72,58.43)

0.30 (− 0.92,1.52)

55.63 (54.10,57.16)

1.92 (− 0.02,3.896)

 Median (Range)

58.25 (55,60)

0 (0,1)

55 (55,60)

0 (− 1.25,5)

Visit 9

 Mean (95% CI)

56.83 (55.40,58.26)

0.39 (−0.89,1.67)

55.02 (52.98,57.05)

1.39 (−0.54,5.22)

 Median (Range)

57.5 (55,60)

0 (−2.5,2.5)

55 (55,57.5)

0 (−1,5)