Table 3.

TEAEs by SOC in the safety set.

	Study group (Growtropin-II) (n = 30)	Control group (Genotropin) (n = 30)	Total (n = 60)	P value
	Number of subjects (%) [number of cases]
TEAEs	16 (53.33%) [76]	13 (43.33%) [66]	29 (48.33%) [142]	.4383
Infections and infestations	12 (40.00%) [52]	10 (33.33%) [45]	22 (36.67%) [97]
Respiratory, thoracic and mediatinal disorders	7 (23.33%) [9]	3 (10.00%) [6]	10 (16.67%) [15]
General disorders and administration site conditions	3 (10.00%) [3]	4 (13.33%) [5]	7 (11.67%) [8]
Gastrointestinal disorders	2 (6.67%) [2]	3 (10.00%) [4]	5 (8.33%) [6]
Eye disorders	4 (13.33%) [4]	1 (3.33%) [1]	5 (8.33%) [5]
Skin and subcutaneous disorders	2 (3.37%) [2]	1 (3.33%) [1]	3 (5.00%) [3]
Congenital, familial and genetic disorders	1 (3.33%) [1]	1 (3.33%) [1]	2 (3.33%) [2]
Injury, poisoning and procedural complications	1 (3.33%) [1]	1 (3.33%) [1]	2 (3.33%) [2]
Investigations	0	1 (3.33%) [1]	1 (1.67%) [1]
Musculoskeletal and connective tissue disorders	1 (3.33%) [1]	0	1 (1.67%) [1]
Psychiatric dis orders	1 (3.33%) [1]	0	1 (1.67%) [1]
Renal and urinary disorders	0	1 (3.33%) [1]	1 (1.67%) [1]