Table 4.
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