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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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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Inclusion Criteria:
Pediatric patients at high risk of RSV disease, who need the prevention of serious lower respiratory tract disease caused by RSV, and meet any of the following criteria:
Obtained authorization form to use personal and/or health data from legal representative prior to the entry into the study.
Exclusion Criteria:
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General hospital
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| Name | Affiliation | Role |
|---|---|---|
| SoRa Lee, MD | AbbVie | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 618 participants were enrolled; 1 participant was a duplicate enrollment and the duplicate data was excluded from the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pediatric Participants at High Risk of RSV | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 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 |
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pediatric Participants at High Risk of RSV | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| Other |
|
| months |
|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | 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.
|
|
| 46 |
| 617 |
| 32 |
| 617 |
| Bronchiolitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Rhinovirus infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Pneumonia adenoviral | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Adenovirus infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| H1N1 influenza | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| Parainfluenzae virus infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Urinary tract infection bacterial | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Death | General disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Clonic convulsion | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Hydrocephalus | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Retinopathy of prematurity | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Cyanosis | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Feeding disorder neonatal | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
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.
| D014777 | Virus Diseases |
| D007239 | Infections |