Table 5.
Sandoz proposed biosimilar pegfilgrastim N = 176, n (%) |
Reference pegfilgrastim N = 178, n (%) | |
---|---|---|
Total number of subjects with at least one TEAE | 170 (97) | 172 (97) |
Musculoskeletal and connective tissue disorders | 163 (93) | 161 (90) |
Nervous system disorders | 107 (61) | 109 (61) |
General disorders and administration site conditions | 79 (45) | 75 (42) |
Gastrointestinal disorders | 39 (22) | 44 (25) |
Infections and infestations | 19 (11) | 21 (12) |
Respiratory, thoracic and mediastinal disorders | 16 (9) | 19 (11) |
N, number of subjects in treatment group; n, number of subjects with event; TEAE, treatment‐emergent adverse event