Table 4.

SAEs by SOC and PT 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 events]
SAEs	3 (10.00%) [6]	5 (16.67%) [11]	8 (13.33%) [17]	.7065
Infections and infestations	0 (00.00%) [0]	3 (10.00%) [7]	3 (5.00%) [7]
Bronchitis	0	1 (3.33%) [1]	1 (1.67%) [1]
Chronic tonsillitis	0	1 (3.33%) [1]	1 (1.67%) [1]
Herpangina	0	1 (3.33%) [1]	1 (1.67%) [1]
Influenza	0	1 (3.33%) [1]	1 (1.67%) [1]
Otitis media	0	1 (3.33%) [1]	1 (1.67%) [1]
Rhinitis	0	1 (3.33%) [1]	1 (1.67%) [1]
Tonsillitis	0	1 (3.33%) [1]	1 (1.67%) [1]
Respiratory, thoracic and mediastinal disorders	2 (6.67%) [4]	1 (3.33%) [2]	3 (5.00%) [6]
Adenoidal hypertrophy	2 (6.67%) [2]	1 (3.33%) [1]	3 (5.00%) [3]
Tonsillar hypertrophy	2 (6.67%) [2]	1 (3.33%) [2]	3 (5.00%) [3]
Congenital, familial and genetic disorders	1 (3.33%) [1]	1 (3.33%) [1]	2 (3.33%) [2]
Atrial septal defect	1 (3.33%) [1]	0	1 (1.67%) [1]
Hydrocele	0	1 (3.33%) [1]	1 (1.67%) [1]
Gastrointestinal disorders	0	1 (3.33%) [1]	1 (1.67%) [1]
Inguinal hernia	0	1 (3.33%) [1]	1 (1.67%) [1]
General disorders and administration site conditions	1 (3.33%) [1]	0	1 (1.67%) [1]
Pyrexia	1 (3.33%) [1]	0	1 (1.67%) [1]