Approximately 600 pediatric patients prescribed palivizumab (Synagis) prophylaxis in usual practice according to the approved Korean product label will be registered into this observational study. Baseline data will be obtained at enrollment including demographics, gestational age, birth weight and underlying diseases and complications especially in regard to respiratory disease and cardiovascular disease. At routine visits for Synagis administration, which will occur according to usual medical practice, information on Synagis prophylaxis, concomitant medication, and adverse events will be collected for up to 30 days after the last administration of Synagis.
Study Type
OBSERVATIONAL
Enrollment
618
Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs)
An AE was defined as any untoward medical occurrence that did not necessarily have a causal relationship with treatment. An SAE was an event that resulted in death, was life-threatening, required or prolonged hospitalization, resulted in congenital anomaly or persistent or significant disability, important medical event requiring medical or surgical intervention to prevent serious outcome, or a spontaneous or elective abortion. AEs considered to be related to Synagis were classified as ADRs. The causality of ADRs were assessed by the investigator as 'Probable,' 'Possible' and 'others (unknown). 'Unexpected' AEs are those that are unlabeled.
Time frame: From the time of informed consent until 30 days after the final administration of Synagis, an expected average of 6 months from the start of Synagis
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