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Table 4 Adverse events in ITT population

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

 

AC

TH

ACTH

TA4415V N (%)

Reference trastuzumab N (%)

TA4415V N (%)

Reference trastuzumab N (%)

At least possibly related AE

–

53 (98.15)

49 (90.74)

24 (44.44)

28 (51.85)

Serious AE

1 (0.93)

0 (0.00)

0 (0.00)

0 (0.00)

0 (0.00)

Number of subjects reporting at least one grade 3 or 4 AE

32 (29.63)

27 (50.00)

29 (53.70)

1 (1.85)

1 (1.85)

AEs leading to drug discontinuation

1 (0.93)

1 (1.85)

0 (0.00)

0 (0.00)

0 (0.00)