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

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

Adverse drug reaction^a,^b	Patients, n (%)	Incidence (patient-years^c = 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

ISSN: 1824-7288