Surveillance of Synagis in Korean Pediatric Patients
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|ClinicalTrials.gov Identifier: NCT01537198|
Recruitment Status : Completed
First Posted : February 23, 2012
Results First Posted : July 10, 2015
Last Update Posted : July 10, 2015
|Condition or disease|
|Respiratory Syncytial Virus Infection|
|Study Type :||Observational|
|Actual Enrollment :||618 participants|
|Official Title:||Post-Marketing Surveillance of Synagis in Korean Pediatric Patients Under the "New Drug Re-Examination"|
|Study Start Date :||January 2012|
|Primary Completion Date :||June 2014|
|Study Completion Date :||June 2014|
Pediatric Participants at High Risk of RSV
Pediatric participants at high risk of respiratory syncytial virus (RSV) in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant's enrollment in the study.
- Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs) [ 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01537198
|Study Director:||SoRa Lee, MD||AbbVie|