Trial Outcomes & Findings for Surveillance of Synagis in Korean Pediatric Patients (NCT NCT01537198)
NCT ID: NCT01537198
Last Updated: 2015-07-10
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
618 participants
Primary outcome timeframe
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
Results posted on
2015-07-10
Participant Flow
A total of 618 participants were enrolled; 1 participant was a duplicate enrollment and the duplicate data was excluded from the analysis.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
617
|
|
Overall Study
COMPLETED
|
463
|
|
Overall Study
NOT COMPLETED
|
154
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
|
Overall Study
RSV infection
|
2
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
No Further Visits to the Clinic
|
37
|
|
Overall Study
Other
|
111
|
Baseline Characteristics
Surveillance of Synagis in Korean Pediatric Patients
Baseline characteristics by cohort
| Measure |
Pediatric Participants at High Risk of RSV
n=617 Participants
Pediatric participants at high risk of 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.
|
|---|---|
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Age, Continuous
|
3.38 months
STANDARD_DEVIATION 3.39 • n=93 Participants
|
|
Age, Customized
Newborn infants (0 to 27 days)
|
166 participants
n=93 Participants
|
|
Age, Customized
Infants and toddlers (28 days to 23 months)
|
451 participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
281 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
336 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 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 SynagisAn 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.
Outcome measures
| Measure |
Pediatric Participants at High Risk of RSV
n=617 Participants
Pediatric participants at high risk of 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.
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|---|---|
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Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs)
Any AE
|
126 participants
|
|
Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs)
Any ADR
|
3 participants
|
|
Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs)
Any SAE
|
46 participants
|
|
Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs)
Any serious ADR
|
3 participants
|
|
Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs)
Any unexpected AE
|
67 participants
|
|
Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs)
Any unexpected ADR
|
0 participants
|
Adverse Events
Pediatric Participants at High Risk of RSV
Serious events: 46 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pediatric Participants at High Risk of RSV
n=617 participants at risk
Pediatric participants at high risk of 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.
|
|---|---|
|
Infections and infestations
Respiratory syncytial virus infection
|
1.8%
11/617 • 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
|
|
Infections and infestations
Bronchiolitis
|
0.97%
6/617 • 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
|
|
Infections and infestations
Pneumonia
|
0.65%
4/617 • 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
|
|
Infections and infestations
Rhinovirus infection
|
0.32%
2/617 • 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
|
|
Infections and infestations
Gastroenteritis
|
0.32%
2/617 • 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
|
|
Infections and infestations
Influenza
|
0.32%
2/617 • 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
|
|
Infections and infestations
Pneumonia adenoviral
|
0.16%
1/617 • 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
|
|
Infections and infestations
Adenovirus infection
|
0.16%
1/617 • 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
|
|
Infections and infestations
Bacteraemia
|
0.16%
1/617 • 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
|
|
Infections and infestations
Bronchitis
|
0.16%
1/617 • 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
|
|
Infections and infestations
H1N1 influenza
|
0.16%
1/617 • 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
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.16%
1/617 • 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
|
|
Infections and infestations
Upper respiratory tract infection
|
0.16%
1/617 • 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
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.16%
1/617 • 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
|
|
General disorders
Pyrexia
|
0.65%
4/617 • 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
|
|
General disorders
Condition aggravated
|
0.49%
3/617 • 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
|
|
General disorders
Death
|
0.16%
1/617 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.32%
2/617 • 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
|
|
Nervous system disorders
Clonic convulsion
|
0.16%
1/617 • 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
|
|
Nervous system disorders
Convulsion
|
0.16%
1/617 • 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
|
|
Nervous system disorders
Hydrocephalus
|
0.16%
1/617 • 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
|
|
Eye disorders
Retinopathy of prematurity
|
0.32%
2/617 • 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
|
|
Cardiac disorders
Cardiac failure
|
0.32%
2/617 • 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
|
|
Cardiac disorders
Arrhythmia
|
0.16%
1/617 • 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
|
|
Cardiac disorders
Cyanosis
|
0.16%
1/617 • 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
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.16%
1/617 • 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
|
|
Metabolism and nutrition disorders
Feeding disorder neonatal
|
0.16%
1/617 • 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
|
Other adverse events
| Measure |
Pediatric Participants at High Risk of RSV
n=617 participants at risk
Pediatric participants at high risk of 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.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
5.2%
32/617 • 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
|
Additional Information
Global Medical Information
AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER