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Table 6 Serious Adverse Events in Cycles 1 or 2

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 (%)
Any Serious Adverse Event in Cycle 1 or 2 10 (8.3) 8 (6.8)
Blood and lymphatic system disorders 5 (4.1) 7 (6.0)
 Febrile neutropenia 5 (4.1) 6 (5.1)
 Neutropenia 0 2 (1.7)
Infections and infestations 2 (1.7) 1 (0.9)
 Cystitis 0 1 (0.9)
 Neutropenic infection 1 (0.8) 0
 Oesophageal candidiasis 1 (0.8) 0
Vascular disorders 2 (1.7) 0
 Lymphorrhoea 2 (1.7) 0
Gastrointestinal disorders 1 (0.8) 0
 Haemorrhagic duodenitis 1 (0.8) 0
 Erosive duodenitis 1 (0.8) 0
Neoplasms benign, malignant and unspecified (including cysts and polyps) 1 (0.8) 0
 Metastases to central nervous system 1 (0.8) 0