Table 2.

Safety outcomes: treatment-emergent adverse events

	r-hGH 12 months (n = 59)		Control (n = 30)
	with event, n (%)	events, n	with event, n (%)	events, n
12 months of treatment (baseline to last visit)
Any TEAE	42 (71.2)	179	18 (60.0)	83
Any serious TEAE	3 (5.1)	5	1 (3.3)	3
Any treatment-related TEAE	0 (0)	0	1 (3.3)	2
Any treatment-related serious TEAE	0 (0)	0	0 (0)	0
Any TEAE leading to study treatment discontinuation	0 (0)	0	0 (0)	0
Any TEAE leading to death	0 (0)	0	0 (0)	0
6 months of treatment (baseline to 6-month visit)
Any TEAE	38 (64.4)	93	15 (50.0)	42
Any serious TEAE	3 (5.1)	5	1 (3.3)	3
Any treatment-related TEAE	0 (0)	0	0 (0)	0
Any treatment-related serious TEAE	0 (0)	0	0 (0)	0
Any TEAE leading to study treatment discontinuation	n/a	n/a	n/a	n/a
Any TEAE leading to death	0 (0)	0	0 (0)	0

r-hGH, recombinant human growth hormone; TEAE, treatment-emergent adverse event; n/a, not applicable.