Table 3.

Incidence of unsolicited adverse events.

System organ class Preferred term, n (%)	Number (%) of subjects [number of events] in
	6–35 months group (n = 118)	3–17 y group (n = 118)	Overall (N = 236)
General disorders and administration site conditions
Pyrexia	7 (5.9) [8]	–	7 (3.0) [8]
Malaise	2 (1.7) [2]	–	2 (0.8) [2]
Infections and infestations
Nasopharyngitis	3 (2.5) [3]	3 (2.5) [3]	6 (2.5) [6]
Bronchitis	1 (0.8) [1]	–	1 (0.4) [1]
Respiratory, thoracic and mediastinal disorders
Cough	2 (1.7) [3]	2 (1.7) [2]	4 (1.7) [5]
Rhinorrhea	1 (0.8) [1]	–	1 (0.4) [1]
Throat irritation	1 (0.8) [1]	–	1 (0.4) [1]
Musculoskeletal and connective tissue disorders
Pain in extremity	–	1 (0.8) [1]	1 (0.4) [1]
Nervous system disorders
Generalized tonic-clonic seizure	–	1 (0.8) [1]	1 (0.4) [1]
Gastrointestinal disorders
Diarrhea	3 (2.5) [3]	–	3 (1.3) [3]