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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)