Trial Outcomes & Findings for A One-Year Observation of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America (NCT NCT01297504)
NCT ID: NCT01297504
Last Updated: 2014-10-01
Results Overview
Study participants were characterized at Baseline by history of bronchopulmonary dysplasia, history of prematurity (less than or equal to 35 weeks gestational age), children with hemodynamically significant congenital heart disease (CHD), the presence of cohabitants less than 6 years old, possible exposure to indoor tobacco smoke, day care attendance, asthmatic or atopic mother, smoking during pregnancy, breastfeeding, prenatal assistance (4 or more visits during pregnancy), neonatal hospitalization care, history of neonatal assisted ventilation, and mother education level (completed primary school).
Recruitment status
COMPLETED
Target enrollment
464 participants
Primary outcome timeframe
Baseline
Results posted on
2014-10-01
Participant Flow
Participant milestones
| Measure |
Palivizumab
Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
|
|---|---|
|
Overall Study
STARTED
|
464
|
|
Overall Study
Participants Studied
|
458
|
|
Overall Study
COMPLETED
|
397
|
|
Overall Study
NOT COMPLETED
|
67
|
Reasons for withdrawal
| Measure |
Palivizumab
Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
|
|---|---|
|
Overall Study
Invalid Consent
|
1
|
|
Overall Study
Received Palivizumab in Previous Season
|
1
|
|
Overall Study
No Study Visits
|
4
|
|
Overall Study
Death
|
3
|
|
Overall Study
Lost to Follow-up
|
43
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Site Closure
|
3
|
|
Overall Study
Protocol Violation
|
3
|
Baseline Characteristics
A One-Year Observation of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America
Baseline characteristics by cohort
| Measure |
Palivizumab
n=458 Participants
Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
|
|---|---|
|
Age, Continuous
|
55 days
n=99 Participants
|
|
Sex: Female, Male
Female
|
219 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
239 Participants
n=99 Participants
|
|
Region of Enrollment
Mexico
|
100 participants
n=99 Participants
|
|
Region of Enrollment
Ecuador
|
7 participants
n=99 Participants
|
|
Region of Enrollment
Argentina
|
149 participants
n=99 Participants
|
|
Region of Enrollment
Uruguay
|
10 participants
n=99 Participants
|
|
Region of Enrollment
Peru
|
13 participants
n=99 Participants
|
|
Region of Enrollment
Chile
|
32 participants
n=99 Participants
|
|
Region of Enrollment
Colombia
|
147 participants
n=99 Participants
|
|
Birth Weight
|
1344.6 g
STANDARD_DEVIATION 460.5 • n=99 Participants
|
PRIMARY outcome
Timeframe: BaselineStudy participants were characterized at Baseline by history of bronchopulmonary dysplasia, history of prematurity (less than or equal to 35 weeks gestational age), children with hemodynamically significant congenital heart disease (CHD), the presence of cohabitants less than 6 years old, possible exposure to indoor tobacco smoke, day care attendance, asthmatic or atopic mother, smoking during pregnancy, breastfeeding, prenatal assistance (4 or more visits during pregnancy), neonatal hospitalization care, history of neonatal assisted ventilation, and mother education level (completed primary school).
Outcome measures
| Measure |
Palivizumab
n=458 Participants
Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
|
LTRI Due to RSV
Hospitalizations due to lower respiratory tract infections (LRTI) caused by RSV
|
|---|---|---|
|
Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection
History of bronchopulmonary dysplasia
|
134 participants
|
—
|
|
Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection
Prematurity
|
449 participants
|
—
|
|
Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection
Congenital heart disease
|
46 participants
|
—
|
|
Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection
Presence of cohabitants <6 years of age
|
160 participants
|
—
|
|
Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection
Smoking at home
|
78 participants
|
—
|
|
Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection
Day care attendance
|
5 participants
|
—
|
|
Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection
Asthmatic / atopic mother
|
55 participants
|
—
|
|
Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection
Smoking during pregnancy
|
9 participants
|
—
|
|
Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection
Breastfeeding
|
336 participants
|
—
|
|
Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection
Prenatal assistance
|
386 participants
|
—
|
|
Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection
Neonatal care hospitalization
|
447 participants
|
—
|
|
Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection
History of neonatal assisted ventilation
|
257 participants
|
—
|
|
Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection
Mother education level
|
443 participants
|
—
|
PRIMARY outcome
Timeframe: BaselineThe percentage of participants with each and combinations of the three comorbidities for which palivizumab is indicated.
Outcome measures
| Measure |
Palivizumab
n=458 Participants
Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
|
LTRI Due to RSV
Hospitalizations due to lower respiratory tract infections (LRTI) caused by RSV
|
|---|---|---|
|
Distribution of Comorbidities in Study Participants
Prematurity only
|
64.63 percentage of participants
|
—
|
|
Distribution of Comorbidities in Study Participants
Bronchopulmonary dysplasia (BPD) only
|
0.87 percentage of participants
|
—
|
|
Distribution of Comorbidities in Study Participants
Congenital heart disease (CHD) only
|
0.87 percentage of participants
|
—
|
|
Distribution of Comorbidities in Study Participants
BPD + Prematurity
|
24.45 percentage of participants
|
—
|
|
Distribution of Comorbidities in Study Participants
Prematurity + CHD
|
5.24 percentage of participants
|
—
|
|
Distribution of Comorbidities in Study Participants
Prematurity + BPD + CHD
|
3.71 percentage of participants
|
—
|
|
Distribution of Comorbidities in Study Participants
BPD + CHD
|
0.22 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 12 monthsThe number of participants with hospitalizations due to lower respiratory tract infection (LRTI) and hospitalizations due to lower respiratory tract infection caused by RSV.
Outcome measures
| Measure |
Palivizumab
n=458 Participants
Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
|
LTRI Due to RSV
Hospitalizations due to lower respiratory tract infections (LRTI) caused by RSV
|
|---|---|---|
|
Number of Participants With Hospitalizations for Lower Respiratory Tract Infection and RSV
Hospitalization due to LRTI
|
52 participants
|
—
|
|
Number of Participants With Hospitalizations for Lower Respiratory Tract Infection and RSV
Hospitalization due to LRTI due to RSV
|
12 participants
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants with hospitalization due to LTRI and hospitalization due to LTRI and RSV.
Outcome measures
| Measure |
Palivizumab
n=61 Hospitalization episodes
Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
|
LTRI Due to RSV
n=12 Hospitalization episodes
Hospitalizations due to lower respiratory tract infections (LRTI) caused by RSV
|
|---|---|---|
|
Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV
Prematurity
|
60 hospitalization episodes
|
12 hospitalization episodes
|
|
Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV
Bronchopulmonary dysplasia
|
32 hospitalization episodes
|
9 hospitalization episodes
|
|
Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV
Congenital heart disease
|
7 hospitalization episodes
|
1 hospitalization episodes
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsVariables that could act as risk factors for hospitalization for lower respiratory tract infection were tested in univariate and multivariate Poisson regression models. Baseline characteristics, such as age, gender, birth weight and comorbidities were included as covariates in the Poisson regression model. Variables for multivariate analysis were added applying forward selection. Gestational age and birth weight were included as continuous variables, considering that the higher they were the better they could act as a protection factor for hospitalization due to respiratory infection.
Outcome measures
| Measure |
Palivizumab
n=458 Participants
Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
|
LTRI Due to RSV
n=458 Participants
Hospitalizations due to lower respiratory tract infections (LRTI) caused by RSV
|
|---|---|---|
|
Risk Factors for Hospitalization
Sex (Female)
|
0.919 rate ratio
Interval 0.553 to 1.528
|
0.925 rate ratio
Interval 0.545 to 1.569
|
|
Risk Factors for Hospitalization
Gestational Age
|
0.925 rate ratio
Interval 0.84 to 1.018
|
1.022 rate ratio
Interval 0.866 to 1.207
|
|
Risk Factors for Hospitalization
Bronchopulmonar Dysplasia
|
2.768 rate ratio
Interval 1.667 to 4.597
|
2.754 rate ratio
Interval 1.53 to 4.957
|
|
Risk Factors for Hospitalization
Birth Weight
|
0.9996 rate ratio
Interval 0.9989 to 1.0002
|
0.9998 rate ratio
Interval 0.999 to 1.001
|
|
Risk Factors for Hospitalization
Cardiopathy
|
1.149 rate ratio
Interval 0.494 to 2.671
|
0.925 rate ratio
Interval 0.378 to 2.265
|
|
Risk Factors for Hospitalization
Smoking
|
2.546 rate ratio
Interval 0.797 to 8.13
|
1.36 rate ratio
Interval 0.378 to 4.889
|
|
Risk Factors for Hospitalization
Compliance
|
1.004 rate ratio
Interval 0.995 to 1.013
|
1.005 rate ratio
Interval 0.996 to 1.014
|
|
Risk Factors for Hospitalization
Maternal Education (elementary)
|
2.108 rate ratio
Interval 1.038 to 4.282
|
1.84 rate ratio
Interval 0.849 to 3.989
|
SECONDARY outcome
Timeframe: 12 monthsCompliance to prescribed palivizumab was calculated based on the number of doses received versus the expected number of doses for each participant. The expected number of doses for each participant was estimated based on seasonality and current prescription guidelines for each country.
Outcome measures
| Measure |
Palivizumab
n=458 Participants
Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
|
LTRI Due to RSV
Hospitalizations due to lower respiratory tract infections (LRTI) caused by RSV
|
|---|---|---|
|
Compliance to Prescribed Palivizumab
|
83.66 Percentage of expected dose
Interval 80.83 to 86.48
|
—
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Palivizumab
n=458 Participants
Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
|
LTRI Due to RSV
Hospitalizations due to lower respiratory tract infections (LRTI) caused by RSV
|
|---|---|---|
|
Mean Number of Doses of Palivizumab Administered
|
3.8 doses
Standard Deviation 1.26
|
—
|
Adverse Events
Palivizumab
Serious events: 102 serious events
Other events: 299 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Palivizumab
n=458 participants at risk
Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
|
|---|---|
|
Renal and urinary disorders
Acute prerenal failure
|
0.22%
1/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Apparent life-threatening event
|
0.22%
1/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory distress syndrome
|
0.44%
2/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.44%
2/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.3%
6/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.44%
2/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
0.44%
2/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.66%
3/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.22%
1/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
17/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.87%
4/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.66%
3/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.22%
1/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Infantile apneic attack
|
0.44%
2/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.22%
1/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal mass
|
0.22%
1/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.87%
4/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.44%
2/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumopathy
|
0.22%
1/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.22%
1/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.87%
4/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Prolonged expiration
|
0.22%
1/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.44%
2/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.22%
1/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.44%
2/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.66%
3/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
3.5%
16/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.22%
1/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.44%
2/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.22%
1/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.22%
1/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.44%
2/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.22%
1/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Use of accessory respiratory muscles
|
0.22%
1/458 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.1%
5/458 • 12 months
|
|
Infections and infestations
Bacterial infection
|
0.44%
2/458 • 12 months
|
|
Infections and infestations
Bronchitis
|
0.66%
3/458 • 12 months
|
|
Infections and infestations
Bronchiolitis
|
6.1%
28/458 • 12 months
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.22%
1/458 • 12 months
|
|
Infections and infestations
Gastroenterocolitis
|
0.22%
1/458 • 12 months
|
|
Infections and infestations
Gastroenteritis
|
1.3%
6/458 • 12 months
|
|
Infections and infestations
Haemophilus infection
|
0.44%
2/458 • 12 months
|
|
Infections and infestations
Influenza
|
0.22%
1/458 • 12 months
|
|
Infections and infestations
Laryngitis
|
0.22%
1/458 • 12 months
|
|
Infections and infestations
Lower respiratory tract infection
|
0.44%
2/458 • 12 months
|
|
Infections and infestations
Lung infection pseudomonal
|
0.22%
1/458 • 12 months
|
|
Infections and infestations
Meningitis
|
0.22%
1/458 • 12 months
|
|
Infections and infestations
Nasopharyngitis
|
0.44%
2/458 • 12 months
|
|
Infections and infestations
Obstructive bronchitis
|
0.22%
1/458 • 12 months
|
|
Infections and infestations
Otitis media recurrent
|
0.22%
1/458 • 12 months
|
|
Infections and infestations
Parainfluenzae viral laryngotracheobronchitis
|
0.22%
1/458 • 12 months
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.22%
1/458 • 12 months
|
|
Infections and infestations
Pertussis
|
0.22%
1/458 • 12 months
|
|
Infections and infestations
Pharyngitis
|
0.87%
4/458 • 12 months
|
|
Infections and infestations
Pneumonia
|
1.7%
8/458 • 12 months
|
|
Infections and infestations
Pneumonia bacterial
|
0.66%
3/458 • 12 months
|
|
Infections and infestations
Pneumonia chlamydial
|
0.22%
1/458 • 12 months
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.22%
1/458 • 12 months
|
|
Infections and infestations
Pneumonia streptococcal
|
0.22%
1/458 • 12 months
|
|
Infections and infestations
Pneumonia viral
|
1.5%
7/458 • 12 months
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.44%
2/458 • 12 months
|
|
Infections and infestations
Sepsis
|
0.22%
1/458 • 12 months
|
|
Infections and infestations
Sepsis neonatal
|
0.22%
1/458 • 12 months
|
|
Infections and infestations
Staphylococcal sepsis
|
0.22%
1/458 • 12 months
|
|
Infections and infestations
Viral infection
|
0.22%
1/458 • 12 months
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
5/458 • 12 months
|
|
Infections and infestations
Urinary tract infection
|
0.66%
3/458 • 12 months
|
|
Nervous system disorders
Convulsion
|
0.22%
1/458 • 12 months
|
|
Nervous system disorders
Hydrocephalus
|
0.22%
1/458 • 12 months
|
|
Nervous system disorders
Infantile spasms
|
0.22%
1/458 • 12 months
|
|
Nervous system disorders
Loss of consciousness
|
0.22%
1/458 • 12 months
|
|
Nervous system disorders
Somnolence
|
0.22%
1/458 • 12 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.22%
1/458 • 12 months
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.22%
1/458 • 12 months
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.22%
1/458 • 12 months
|
|
Immune system disorders
Milk allergy
|
0.22%
1/458 • 12 months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.22%
1/458 • 12 months
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.22%
1/458 • 12 months
|
|
Injury, poisoning and procedural complications
Gastrointestinal atoma complication
|
0.22%
1/458 • 12 months
|
|
Eye disorders
Retinopathy of prematurity
|
0.22%
1/458 • 12 months
|
|
Cardiac disorders
Bradycardia
|
0.22%
1/458 • 12 months
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.22%
1/458 • 12 months
|
|
Cardiac disorders
Cyanosis
|
2.4%
11/458 • 12 months
|
|
Vascular disorders
Jugular vein thrombosis
|
0.22%
1/458 • 12 months
|
|
Vascular disorders
Haemodynamic instability
|
0.22%
1/458 • 12 months
|
|
Cardiac disorders
Heart failure
|
0.22%
1/458 • 12 months
|
|
Vascular disorders
Pallor
|
0.44%
2/458 • 12 months
|
|
Cardiac disorders
Subvalvular aortic stenosis
|
0.22%
1/458 • 12 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.44%
2/458 • 12 months
|
|
Gastrointestinal disorders
Abdominal mass
|
0.22%
1/458 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.22%
1/458 • 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
9/458 • 12 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.4%
11/458 • 12 months
|
|
Gastrointestinal disorders
Haematochezia
|
0.22%
1/458 • 12 months
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.22%
1/458 • 12 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.1%
5/458 • 12 months
|
|
Gastrointestinal disorders
Meconium ileus
|
0.22%
1/458 • 12 months
|
|
Gastrointestinal disorders
Megacolon
|
0.22%
1/458 • 12 months
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.22%
1/458 • 12 months
|
|
Gastrointestinal disorders
Stools watery
|
0.22%
1/458 • 12 months
|
|
Gastrointestinal disorders
Volvulus of small bowel
|
0.22%
1/458 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
11/458 • 12 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.87%
4/458 • 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.87%
4/458 • 12 months
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.22%
1/458 • 12 months
|
|
Metabolism and nutrition disorders
Feeding disorder
|
0.22%
1/458 • 12 months
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.22%
1/458 • 12 months
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.22%
1/458 • 12 months
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.66%
3/458 • 12 months
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.22%
1/458 • 12 months
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.22%
1/458 • 12 months
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.22%
1/458 • 12 months
|
|
Metabolism and nutrition disorders
Underweight
|
0.22%
1/458 • 12 months
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.22%
1/458 • 12 months
|
|
General disorders
Death
|
0.22%
1/458 • 12 months
|
|
General disorders
Fatigue
|
0.22%
1/458 • 12 months
|
|
General disorders
Fever
|
0.22%
1/458 • 12 months
|
|
General disorders
Hyperthermia
|
0.22%
1/458 • 12 months
|
|
General disorders
Pyrexia
|
3.9%
18/458 • 12 months
|
|
General disorders
Malaise
|
0.66%
3/458 • 12 months
|
|
General disorders
Mucosal Inflammation
|
0.22%
1/458 • 12 months
|
|
General disorders
Irritability
|
0.66%
3/458 • 12 months
|
|
General disorders
General physical health deterioration
|
0.44%
2/458 • 12 months
|
|
Congenital, familial and genetic disorders
Arterial septal defect
|
0.22%
1/458 • 12 months
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.22%
1/458 • 12 months
|
|
Congenital, familial and genetic disorders
Atrioventricular septal defect
|
0.22%
1/458 • 12 months
|
|
Congenital, familial and genetic disorders
Intestinal malrotation
|
0.22%
1/458 • 12 months
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.22%
1/458 • 12 months
|
|
Congenital, familial and genetic disorders
Heart disease congenital
|
0.22%
1/458 • 12 months
|
|
Congenital, familial and genetic disorders
Hypospadias
|
0.44%
2/458 • 12 months
|
|
Congenital, familial and genetic disorders
Laryngomalacia
|
0.22%
1/458 • 12 months
|
|
Congenital, familial and genetic disorders
Pilonidal cyst congenital
|
0.22%
1/458 • 12 months
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.22%
1/458 • 12 months
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.22%
1/458 • 12 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.44%
2/458 • 12 months
|
|
Blood and lymphatic system disorders
Anaemia neonatal
|
0.22%
1/458 • 12 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.22%
1/458 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatoblastoma
|
0.22%
1/458 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.22%
1/458 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin neoplasm bleeding
|
0.22%
1/458 • 12 months
|
|
Investigations
CSF test abnormal
|
0.22%
1/458 • 12 months
|
|
Investigations
Oxygen saturation decreased
|
1.1%
5/458 • 12 months
|
|
Investigations
Oxygen consumption increased
|
0.22%
1/458 • 12 months
|
|
Investigations
Respiratory syncytial virus test positive
|
0.66%
3/458 • 12 months
|
|
Investigations
Urine analysis abnormal
|
0.22%
1/458 • 12 months
|
|
Investigations
Urine output decreased
|
0.22%
1/458 • 12 months
|
|
Investigations
Weight decreased
|
0.22%
1/458 • 12 months
|
|
Psychiatric disorders
Agitation
|
0.22%
1/458 • 12 months
|
|
Surgical and medical procedures
Tracheostomy
|
0.22%
1/458 • 12 months
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.22%
1/458 • 12 months
|
|
Surgical and medical procedures
Oral surgery
|
0.22%
1/458 • 12 months
|
|
Surgical and medical procedures
Ophthalmic fluid drainage
|
0.22%
1/458 • 12 months
|
|
Surgical and medical procedures
Vascular operation
|
0.22%
1/458 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Hypotonia neonatal
|
0.22%
1/458 • 12 months
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.22%
1/458 • 12 months
|
|
Metabolism and nutrition disorders
Feeding disorder of infancy or early childhood
|
0.44%
2/458 • 12 months
|
|
Metabolism and nutrition disorders
Feeding disorder neonatal
|
0.66%
3/458 • 12 months
|
Other adverse events
| Measure |
Palivizumab
n=458 participants at risk
Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
15.9%
73/458 • 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
11.4%
52/458 • 12 months
|
|
General disorders
Pyrexia
|
10.7%
49/458 • 12 months
|
|
Infections and infestations
Bronchiolitis
|
15.5%
71/458 • 12 months
|
|
Infections and infestations
Ear infection
|
5.0%
23/458 • 12 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.0%
23/458 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
23/458 • 12 months
|
|
Infections and infestations
Upper respiratory tract infection
|
52.8%
242/458 • 12 months
|
Additional Information
Global Medical Services
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