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Table 2 Adverse drug reactions in the safety analysis set (n = 186)

From: Long-term safety and efficacy of Omnitrope®, a somatropin biosimilar, in children requiring growth hormone treatment: Italian interim analysis of the PATRO Children study

Adverse drug reactiona,b Patients,
n (%)
Incidence (patient-yearsc = 438.8)
Increased blood creatine phosphokinase 4 (2.2) 11.4
Impaired glucose tolerance 2 (1.1) 4.56
Craniopharyngioma 1 (0.5) 2.28
Drug administration error 1 (0.5) 2.28
Exostosis 1 (0.5) 2.28
Gait disturbance 1 (0.5) 2.28
Headache 1 (0.5) 2.28
Hyperinsulinism 1 (0.5) 2.28
Increased insulin-like growth factor 1 (0.5) 2.28
Metabolic disorder 1 (0.5) 2.28
Sleep apnoea syndrome 1 (0.5) 2.28
Snoring 1 (0.5) 2.28
  1. aPreferred term/MedDRA dictionary
  2. bMild or moderate
  3. cUntil cut-off date