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Table 5 Adverse event (Safety population)

From: Comparing efficacy and safety of P013, a proposed pertuzumab biosimilar, with the reference product in HER2-positive breast cancer patients: a randomized, phase III, equivalency clinical trial

Variable P013 (N = 107) Reference pertuzumab (N = 107)
The most common AEs
 Anaemia 103 (96.26) 100 (93.46)
 Thrombocytopenia 69 (64.49) 70 (65.42)
 Nausea 64 (59.81) 71 (66.36)
 Diarrhoea 61 (57.01) 67 (62.62)
 Leukopenia 56 (52.34) 51 (47.66)
 Neutropenia 49 (45.79) 47 (43.93)
 Vomiting 46 (42.99) 56 (52.34)
 Abdominal pain 43 (40.19) 37 (34.58)
 Pain 38 (35.51) 34 (31.78)
 Dyspepsia 37 (34.58) 31 (28.97)
The most common Grade 3, 4 AEs
 Anaemia 15 (14.02) 10 (9.35)
 Thrombocytopenia 13 (12.15) 14 (13.08)
 Neutropenia 11 (10.28) 10 (9.35)
 Diarrhoea 10 (9.35) 12 (11.21)
 Alanine aminotransferase increased 3 (2.80) 5 (4.67)
 Abdominal pain 2 (1.87) 1 (0.93)
 Diarrhoea infectious 2 (1.87) 1 (0.93)
 Pyrexia 2 (1.87) 1 (0.93)
 Vomiting 0 (0.00) 3 (2.80)
Serious AEs
  24 (22.43) 15 (14.02)
  1. Data are presented as No (%) of patients