Table 2.

Summary of the most common adverse events (> 5 events/100 patient-years).

System Organ Class	Condition^*	Events, n	Events per 100 Patient-Years
Infections and infestations	Nasopharyngitis	305	133.8
	Upper respiratory tract infection	167	73.3
	Gastroenteritis	111	48.7
	Pharyngitis	46	20.2
	Bronchitis	37	16.2
	Influenza	25	11.0
	Otitis media	19	8.3
	Hordeolum	16	7.0
	Bronchitis, acute	13	5.7
	Gastroenteritis, viral	13	5.7
	Pneumonia	12	5.3
	Rhinitis	12	5.3
Laboratory test abnormalities	Alanine aminotransferase increased	33	14.5
	Aspartate aminotransferase increased	27	11.8
	Blood lactate dehydrogenase increased	21	9.2
	Neutrophil count decreased	18	7.9
	Lymphocyte count decreased	17	7.5
	Blood cholesterol increased	15	6.6
	Beta-N-acetyl-D-glucosaminidase increased	12	5.3
Gastrointestinal disorders	Diarrhea	17	7.5
	Vomiting	16	7.0
	Constipation	15	6.6
	Stomatitis	15	6.6
	Abdominal pain	13	5.7
Skin and subcutaneous tissue disorders	Eczema	46	20.2
	Urticaria	28	12.3
	Heat rash	14	6.1
	Rash	12	5.3
Respiratory, thoracic, and mediastinal disorders	Upper respiratory tract inflammation	59	25.9
Respiratory, thoracic, and mediastinal disorders	Rhinitis, allergic	12	5.3
Injury, poisoning, and procedural complications	Arthropod sting	35	15.4
Injury, poisoning, and procedural complications	Contusion	14	6.1
Nervous system disorders	Headache	13	5.7