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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