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. 2018 Sep 28;84(12):2790–2801. doi: 10.1111/bcp.13731

Table 4.

Safety overview of AEs

Number of subjects with at least one Sandoz proposed biosimilar pegfilgrastim N = 176, n (%) Reference pegfilgrastim N = 178, n (%)
TEAE 170 (97) 172 (97)
Study drug‐related AE 168 (95) 170 (96)
Study drug‐related TEAE leading to study drug discontinuation 1 (1) 1 (1)
Serious TEAE 0 0
AE occurring ≥4 weeks after the last IMP administration leading to study drug discontinuation 1 (1) 1 (1)

N, number of subjects in treatment group; n, number of subjects with event; TEAE, treatment‐emergent adverse event; AE, adverse event; IMP, investigational medicinal product