Skip to main content

Table 5 Overall Frequency of Adverse Events

From: Efficacy and safety of RGB-02, a pegfilgrastim biosimilar to prevent chemotherapy-induced neutropenia: results of a randomized, double-blind phase III clinical study vs. reference pegfilgrastim in patients with breast cancer receiving chemotherapy

  RGB-02(N = 121)
n (%)
Reference(N = 117)
n (%)
Number (%) of patients with:
 Any AE 111 (91.7) 113 (96.6)
 Any Grade ≥ 3 AE 23 (19.0) 18 (15.4)
 Any AE related to IMP 26 (21.5) 32 (27.4)
 Any serious AE 13 (10.7) 12 (10.3)
 Any IMP-related serious AE 0 0
 Any AE leading to withdrawal 2 (1.7) 4 (3.4)
 Any IMP-related AE leading to withdrawal 0 0
 Any AE with an outcome of death 2 (1.7) 0
 Any IMP-related AE with an outcome of death 0 0
 Any injection site reaction AE 2 (1.7) 2 (1.7)