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Table 3 Incidence of Severe Neutropenia

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

Reference

Difference(RGB-02 - Reference)

Cycle 1, PP population

 n

117

113

 

 n (%) with severe neutropenia

99 (84.6)

87 (77.0)

 

 Proportion (95% CI) with severe neutropenia

0.846 (0.768, 0.906)

0.770 (0.681, 0.844)

0.076 (−0.055, 0.204)

Cycle 2, PP population

 n

111

103

 

 n (%) with severe neutropenia

60 (54.1)

45 (43.7)

 

 Proportion (95% CI) with severe neutropenia

0.541(0.443, 0.636)

0.437(0.339, 0.538)

0.104(−0.031, 0.236)