A prospective, open-label, non-comparative study of palivizumab prophylaxis in children at high risk of serious respiratory syncytial virus disease in the Russian Federation

Table 2 **Most common adverse events* (≥4% of subjects) by severity and relationship to study drug (N = 100)**

Adverse event,% of subjects^†	Total	Mild	Moderate	Severe	Related to study drug
Gastrointestinal disorders^‡	5	2	3	0	0
Infections	36	20	14	2^\|\|	1^¶
Bronchitis	7	0	7	0	0
Rhinitis	19	16	3	0	1^¶
Upper respiratory tract infection	9	6	3	0	0
Respiratory, thoracic, and mediastinal disorders^§	4	3	1	0	0
Dermatitis	4	4	0	0	1^¶

*Adverse events were defined as treatment-emergent events, occurring after study drug initiation and within 100 days after the last dose of study drug.
^†Subjects could have experienced more than 1 adverse event.
^‡Includes anal stenosis, enteritis, and teething.
^§Includes bronchopulmonary dysplasia, rhinorrhea, and tonsillar hypertrophy.
^||One case each of pneumonia and tonsillitis.
^¶Possibly related to study drug.

ISSN: 1756-0500