Respiratory Syncytial Virus Infections
Conditions
Keywords
Children, Pre-term infants, Congenital heart disease, Infection, Respiratory syncytial virus, Bronchopulmonary dysplasia (BPD), Chronic lung disease (CLD)
Brief summary
The SYNAGIS Registry was carried out in order to gather comprehensive real-world data on the use of palivizumab in children at high risk for serious respiratory syncytial virus (RSV) disease. This registry was designed as a post-marketing observational study, and conducted with the aim of collecting data on palivizumab administration, the risk factors for complicated RSV disease, frequency of hospitalizations, and drug adherence.
Detailed description
Each participant included in this study was observed during his/her palivizumab prophylaxis during the prevailing RSV season. According to the requirements for non-interventional or observational studies, no diagnostic or monitoring procedures were applied to the participants included in the study other than those which would ordinarily be applied in the course of the individual therapeutic strategy. Only data which were part of routine medical care were collected. Data collection was conducted initially in season 2002/2003 using paper-based case report forms (CRFs); beginning in season 2008/2009 a protected internet-based data entry platform was used. Both the paper-based CRFs and the electronic system were subject to changes during the whole time of the registry. Data collection for registry seasons 2002/2003 - 2006/2007 was conducted by use of paper-based CRFs and hospitalization forms. Corresponding results were published in 2011 and are hence depicted together and reported here as a separate reporting group. Registry seasons 2007/2008 and 2008/2009 were considered transitional years in the process of switching the type of data collection to an electronic CRF (eCRF) system. Although data collection of registry 2007/2008 was still paper-based, it was not included in the original publication and hence, results are reported separately. In season 2008/2009 the mode of data collection was switched from paper-based CRFs to an eCRF system, however, several physicians still used the paper-based CRFs for documentation. In order to use all documentations and lose as few data as possible, results for 2008/2009 are based on a combination of paper-based CRF and eCRF data. Hence, it was decided to keep the results for 08/09 separate from the depiction of the homogenous, eCRF-based results of the following seasons. Data collection for registry 09/10 - 15/16 was implemented by an eCRF system. Corresponding results are therefore depicted together in one reporting group.
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
No
Inclusion criteria
* Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the Respiratory syncytial virus season * Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months. * Children less than 2 years of age and with hemodynamically significant congenital heart disease.
Exclusion criteria
* Children with known hypersensitivity to palivizumab or any component of the formulation, or other humanized monoclonal antibodies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With RSV-associated Hospitalization | During RSV season (September to June) from 2002 to 2016 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 | During RSV season (September to June) from 2008 to 2016 | In the season 2008/09, the eCRF system for data collection was introduced. Hospitalization due to RSV infection was documented on a separate hospitalization form in the electronic case report form (eCRF). Physicians were asked to specify a primary diagnosis at hospital discharge. |
| Presence of Complications During Hospitalization | During RSV season (September to June) from 2002 to 2016 | — |
| Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08 | During RSV season (September to June) from 2002 to 2008 | Hospitalization due to RSV was documented on a separate hospitalization form. The data below represent the number of hospitalizations documented on forms; some participants may have had more than one hospitalization. Multiple entries for discharge diagnosis were possible. |
| Parental Cooperation for Registry 08/09 and 09/10 - 15/16 | During RSV season (September to June) from 2008 to 2016 | Cooperation of parents with the prophylaxis regimen was evaluated per injection in registry 08/09 and 09/10 - 15/16. The categories for cooperation ratings were changed to good, satisfying, or bad: Good: all palivizumab doses could be administered as planned; Satisfying: a single palivizumab dose was missed by the parents; Bad: more than one palivizumab doses was missed by the parents. |
| Mean Number of Palivizumab Injections | During RSV season (September to June) from 2002 to 2016 | The mean number of palivizumab injections per participant, per season. |
| Parental Cooperation in Registries 02/03 - 06/07 and 07/08 | During RSV season (September to June) from 2002 to 2008 | Cooperation of parents with the prophylaxis regimen was categorized as very good, good, moderate, bad or very bad. |
Participant flow
Recruitment details
Pre-term infants and children under 24 months with high-risk for respiratory syncytial virus (RSV) were enrolled between September 01 and June 30 during each RSV season from 2002 to 2016. The registry was conducted in Germany.
Pre-assignment details
Results were subdivided into four parts due to procedural changes including changes in the methods of study data reporting during the conduct of the study: * Registry 02/03 - 06/07 * Registry 07/08 * Registry 08/09 * Registry 09/10 - 15/16
Participants by arm
| Arm | Count |
|---|---|
| Palivizumab Registry 02/03 - 06/07 Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2002 to 30 June 2007. | 10,686 |
| Palivizumab Registry 07/08 Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2007 to 30 June 2008. | 3,805 |
| Palivizumab Registry 08/09 Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2008 to 30 June 2009. | 2,248 |
| Palivizumab Registry 09/10 - 15/16 Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016. | 12,729 |
| Total | 29,468 |
Baseline characteristics
| Characteristic | Palivizumab Registry 02/03 - 06/07 | Total | Palivizumab Registry 07/08 | Palivizumab Registry 08/09 | Palivizumab Registry 09/10 - 15/16 |
|---|---|---|---|---|---|
| Age at Start of Immunoprophylaxis Registry 02/03 - 06/07 | 5.2 months STANDARD_DEVIATION 4 | 5.2 months STANDARD_DEVIATION 4 | — | — | — |
| Age at Start of Immunoprophylaxis Registry 07/08 | — | 5.0 months STANDARD_DEVIATION 4 | 5.0 months STANDARD_DEVIATION 4 | — | — |
| Age at Start of Immunoprophylaxis Registry 08/09 | — | 5.9 months STANDARD_DEVIATION 4.9 | — | 5.9 months STANDARD_DEVIATION 4.9 | — |
| Age at Start of Immunoprophylaxis Registry 09/10 - 15/16 | — | 4.3 months STANDARD_DEVIATION 3.6 | — | — | 4.3 months STANDARD_DEVIATION 3.6 |
| Age, Customized 29 to < 33 weeks | 3385 Participants | 9284 Participants | 1161 Participants | 705 Participants | 4033 Participants |
| Age, Customized < 29 weeks | 3582 Participants | 8963 Participants | 1173 Participants | 694 Participants | 3514 Participants |
| Age, Customized 33 to ≤ 35 weeks | 1500 Participants | 5789 Participants | 578 Participants | 474 Participants | 3237 Participants |
| Age, Customized > 35 weeks | 481 Participants | 2965 Participants | 164 Participants | 375 Participants | 1945 Participants |
| Age, Customized Missing | 1738 Participants | 2467 Participants | 729 Participants | 0 Participants | 0 Participants |
| Birth Weight 1000 - 1499 g | 2782 Participants | 7348 Participants | 965 Participants | 538 Participants | 3063 Participants |
| Birth Weight < 1000 g | 3283 Participants | 7925 Participants | 1101 Participants | 595 Participants | 2946 Participants |
| Birth Weight 1500 - 1999 g | 1788 Participants | 5461 Participants | 659 Participants | 424 Participants | 2590 Participants |
| Birth Weight ≥ 2000 g | 2595 Participants | 8411 Participants | 995 Participants | 691 Participants | 4130 Participants |
| Birth Weight Missing | 238 Participants | 323 Participants | 85 Participants | 0 Participants | 0 Participants |
| Immunoprophylaxis with Palivizumab Started in Hospital | 1645 Participants | 5604 Participants | 519 Participants | 313 Participants | 3127 Participants |
| Risk Factors for RSV Complications Attending daycare | 240 Participants | 784 Participants | 109 Participants | 74 Participants | 361 Participants |
| Risk Factors for RSV Complications Breast feeding ≤ 2 months | NA Participants | NA Participants | NA Participants | NA Participants | 5794 Participants |
| Risk Factors for RSV Complications Chronic lung disease | 4179 Participants | 8439 Participants | 1330 Participants | 584 Participants | 2346 Participants |
| Risk Factors for RSV Complications Chronic lung disease therapy | NA Participants | NA Participants | NA Participants | 281 Participants | 1803 Participants |
| Risk Factors for RSV Complications Congenital heart disease | 3001 Participants | 8281 Participants | 1283 Participants | 567 Participants | 3430 Participants |
| Risk Factors for RSV Complications Crowded living conditions | NA Participants | NA Participants | NA Participants | NA Participants | 2592 Participants |
| Risk Factors for RSV Complications Cyanotic heart defect | NA Participants | NA Participants | NA Participants | 123 Participants | 784 Participants |
| Risk Factors for RSV Complications Down syndrome (Trisomy 21) | NA Participants | NA Participants | NA Participants | NA Participants | 249 Participants |
| Risk Factors for RSV Complications Exposition to air pollution | NA Participants | NA Participants | NA Participants | NA Participants | 1710 Participants |
| Risk Factors for RSV Complications Family history of allergic eczema | 713 Participants | NA Participants | 245 Participants | NA Participants | NA Participants |
| Risk Factors for RSV Complications Family history of allergic rhinitis | 1234 Participants | NA Participants | 450 Participants | NA Participants | NA Participants |
| Risk Factors for RSV Complications Family history of asthma | 823 Participants | NA Participants | 304 Participants | NA Participants | 1128 Participants |
| Risk Factors for RSV Complications Family history of atopy | NA Participants | NA Participants | NA Participants | 346 Participants | 2039 Participants |
| Risk Factors for RSV Complications Immunodeficiency | 430 Participants | 798 Participants | 167 Participants | 30 Participants | 171 Participants |
| Risk Factors for RSV Complications Low social status | NA Participants | NA Participants | NA Participants | NA Participants | 2258 Participants |
| Risk Factors for RSV Complications Multiple births | 2607 Participants | 7954 Participants | 922 Participants | 632 Participants | 3793 Participants |
| Risk Factors for RSV Complications Neuromuscular impairment | NA Participants | NA Participants | NA Participants | 120 Participants | 786 Participants |
| Risk Factors for RSV Complications Other children (< 12 years) in household | 4440 Participants | 12136 Participants | 1682 Participants | 1115 Participants | 4899 Participants |
| Risk Factors for RSV Complications Premature birth (< 29 weeks GA) | 3582 Participants | 8963 Participants | 1173 Participants | 694 Participants | 3514 Participants |
| Risk Factors for RSV Complications Premature birth (≤ 35 weeks GA) | 8467 Participants | 24036 Participants | 2912 Participants | 1873 Participants | 10784 Participants |
| Risk Factors for RSV Complications Serious neurological disease | NA Participants | NA Participants | NA Participants | NA Participants | 428 Participants |
| Risk Factors for RSV Complications Smoking in the family | 1422 Participants | 4341 Participants | 482 Participants | 400 Participants | 2037 Participants |
| Risk Factors for RSV Complications Treatment with oxygen at home | NA Participants | NA Participants | NA Participants | 133 Participants | 763 Participants |
| Sex/Gender, Customized Female | 4901 Participants | 13364 Participants | 1737 Participants | 1019 Participants | 5707 Participants |
| Sex/Gender, Customized Male | 5716 Participants | 16009 Participants | 2051 Participants | 1229 Participants | 7013 Participants |
| Sex/Gender, Customized Missing | 69 Participants | 95 Participants | 17 Participants | 0 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 34 / 29,468 |
| serious Total, serious adverse events | 701 / 29,468 |
Outcome results
Primary
Percentage of Participants With RSV-associated Hospitalization
Time frame: During RSV season (September to June) from 2002 to 2016
Population: Evaluable population with available hospitalization data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palivizumab Registry 02/03 - 06/07 | Percentage of Participants With RSV-associated Hospitalization | 1.5 percentage of participants |
| Palivizumab Registry 07/08 | Percentage of Participants With RSV-associated Hospitalization | 1.5 percentage of participants |
| Palivizumab Registry 08/09 | Percentage of Participants With RSV-associated Hospitalization | 0.8 percentage of participants |
| Palivizumab Registry 09/10 - 15/16 | Percentage of Participants With RSV-associated Hospitalization | 0.7 percentage of participants |
Secondary
Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08
Hospitalization due to RSV was documented on a separate hospitalization form. The data below represent the number of hospitalizations documented on forms; some participants may have had more than one hospitalization. Multiple entries for discharge diagnosis were possible.
Time frame: During RSV season (September to June) from 2002 to 2008
Population: Participants in registries 02/03 - 06/07 and 07/08 who were hospitalized, and hospitalization was documented on paper case report forms.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Palivizumab Registry 02/03 - 06/07 | Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08 | Bronchiolitis | 67 hospitalizations |
| Palivizumab Registry 02/03 - 06/07 | Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08 | RSV-Infection | 49 hospitalizations |
| Palivizumab Registry 02/03 - 06/07 | Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08 | RSV-Bronchiolitis | 99 hospitalizations |
| Palivizumab Registry 02/03 - 06/07 | Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08 | Other | 134 hospitalizations |
| Palivizumab Registry 02/03 - 06/07 | Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08 | RSV-Pneumonia | 44 hospitalizations |
| Palivizumab Registry 02/03 - 06/07 | Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08 | Any RSV diagnosis | 154 hospitalizations |
| Palivizumab Registry 02/03 - 06/07 | Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08 | Pneumonia (Viral pneumonia) | 26 hospitalizations |
| Palivizumab Registry 07/08 | Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08 | Any RSV diagnosis | 57 hospitalizations |
| Palivizumab Registry 07/08 | Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08 | Bronchiolitis | 18 hospitalizations |
| Palivizumab Registry 07/08 | Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08 | RSV-Bronchiolitis | 34 hospitalizations |
| Palivizumab Registry 07/08 | Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08 | Pneumonia (Viral pneumonia) | 12 hospitalizations |
| Palivizumab Registry 07/08 | Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08 | RSV-Pneumonia | 14 hospitalizations |
| Palivizumab Registry 07/08 | Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08 | RSV-Infection | 26 hospitalizations |
| Palivizumab Registry 07/08 | Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08 | Other | 70 hospitalizations |
Secondary
Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16
In the season 2008/09, the eCRF system for data collection was introduced. Hospitalization due to RSV infection was documented on a separate hospitalization form in the electronic case report form (eCRF). Physicians were asked to specify a primary diagnosis at hospital discharge.
Time frame: During RSV season (September to June) from 2008 to 2016
Population: Participants in registries 08/09 and 09/10 - 15/16 who were hospitalized, and hospitalization was documented on forms and with available diagnosis data (for registry 09/10 - 15/16)
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Palivizumab Registry 02/03 - 06/07 | Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 | Bronchiolitis | 4 hospitalizations |
| Palivizumab Registry 02/03 - 06/07 | Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 | Acute respiratory failure | 3 hospitalizations |
| Palivizumab Registry 02/03 - 06/07 | Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 | Pneumonia (confirmed by chest radiography) | 18 hospitalizations |
| Palivizumab Registry 02/03 - 06/07 | Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 | Bronchitis | 24 hospitalizations |
| Palivizumab Registry 02/03 - 06/07 | Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 | Not specified | 33 hospitalizations |
| Palivizumab Registry 02/03 - 06/07 | Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 | Apnoea-bradycardia syndrome | 1 hospitalizations |
| Palivizumab Registry 02/03 - 06/07 | Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 | Pneumonia (clinical diagnosis) | 7 hospitalizations |
| Palivizumab Registry 07/08 | Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 | Pneumonia (confirmed by chest radiography) | 19 hospitalizations |
| Palivizumab Registry 07/08 | Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 | Bronchitis | 24 hospitalizations |
| Palivizumab Registry 07/08 | Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 | Bronchiolitis | 32 hospitalizations |
| Palivizumab Registry 07/08 | Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 | Pneumonia (clinical diagnosis) | 9 hospitalizations |
| Palivizumab Registry 07/08 | Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 | Acute respiratory failure | 1 hospitalizations |
| Palivizumab Registry 07/08 | Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 | Apnoea-bradycardia syndrome | 0 hospitalizations |
| Palivizumab Registry 07/08 | Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 | Not specified | 0 hospitalizations |
| Palivizumab Registry 08/09 | Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 | Acute respiratory failure | 3 hospitalizations |
| Palivizumab Registry 08/09 | Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 | Bronchiolitis | 15 hospitalizations |
| Palivizumab Registry 08/09 | Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 | Not specified | 0 hospitalizations |
| Palivizumab Registry 08/09 | Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 | Apnoea-bradycardia syndrome | 2 hospitalizations |
| Palivizumab Registry 08/09 | Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 | Pneumonia (confirmed by chest radiography) | 58 hospitalizations |
| Palivizumab Registry 08/09 | Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 | Pneumonia (clinical diagnosis) | 27 hospitalizations |
| Palivizumab Registry 08/09 | Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 | Bronchitis | 115 hospitalizations |
Secondary
Mean Number of Palivizumab Injections
The mean number of palivizumab injections per participant, per season.
Time frame: During RSV season (September to June) from 2002 to 2016
Population: Evaluable population; for registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palivizumab Registry 02/03 - 06/07 | Mean Number of Palivizumab Injections | 4.7 palivizumab injections | Standard Deviation 1.8 |
| Palivizumab Registry 07/08 | Mean Number of Palivizumab Injections | 4.8 palivizumab injections | Standard Deviation 1.9 |
| Palivizumab Registry 08/09 | Mean Number of Palivizumab Injections | 4.9 palivizumab injections | Standard Deviation 2 |
| Palivizumab Registry 09/10 - 15/16 | Mean Number of Palivizumab Injections | 5.0 palivizumab injections | Standard Deviation 2 |
Secondary
Parental Cooperation for Registry 08/09 and 09/10 - 15/16
Cooperation of parents with the prophylaxis regimen was evaluated per injection in registry 08/09 and 09/10 - 15/16. The categories for cooperation ratings were changed to good, satisfying, or bad: Good: all palivizumab doses could be administered as planned; Satisfying: a single palivizumab dose was missed by the parents; Bad: more than one palivizumab doses was missed by the parents.
Time frame: During RSV season (September to June) from 2008 to 2016
Population: Evaluable population in in registries 08/09 and 09/10 - 15/16; for registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Palivizumab Registry 02/03 - 06/07 | Parental Cooperation for Registry 08/09 and 09/10 - 15/16 | Good | 8175 Palivizumab injections |
| Palivizumab Registry 02/03 - 06/07 | Parental Cooperation for Registry 08/09 and 09/10 - 15/16 | Satisfying | 550 Palivizumab injections |
| Palivizumab Registry 02/03 - 06/07 | Parental Cooperation for Registry 08/09 and 09/10 - 15/16 | Bad | 143 Palivizumab injections |
| Palivizumab Registry 02/03 - 06/07 | Parental Cooperation for Registry 08/09 and 09/10 - 15/16 | Missing | 2171 Palivizumab injections |
| Palivizumab Registry 07/08 | Parental Cooperation for Registry 08/09 and 09/10 - 15/16 | Missing | 8604 Palivizumab injections |
| Palivizumab Registry 07/08 | Parental Cooperation for Registry 08/09 and 09/10 - 15/16 | Good | 51408 Palivizumab injections |
| Palivizumab Registry 07/08 | Parental Cooperation for Registry 08/09 and 09/10 - 15/16 | Bad | 575 Palivizumab injections |
| Palivizumab Registry 07/08 | Parental Cooperation for Registry 08/09 and 09/10 - 15/16 | Satisfying | 2985 Palivizumab injections |
Secondary
Parental Cooperation in Registries 02/03 - 06/07 and 07/08
Cooperation of parents with the prophylaxis regimen was categorized as very good, good, moderate, bad or very bad.
Time frame: During RSV season (September to June) from 2002 to 2008
Population: Evaluable population in registries 02/03 - 06/07 and 07/08
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Palivizumab Registry 02/03 - 06/07 | Parental Cooperation in Registries 02/03 - 06/07 and 07/08 | Bad/very bad | 354 Participants |
| Palivizumab Registry 02/03 - 06/07 | Parental Cooperation in Registries 02/03 - 06/07 and 07/08 | Moderate | 567 Participants |
| Palivizumab Registry 02/03 - 06/07 | Parental Cooperation in Registries 02/03 - 06/07 and 07/08 | Missing | 382 Participants |
| Palivizumab Registry 02/03 - 06/07 | Parental Cooperation in Registries 02/03 - 06/07 and 07/08 | Very good/good | 9383 Participants |
| Palivizumab Registry 07/08 | Parental Cooperation in Registries 02/03 - 06/07 and 07/08 | Missing | 142 Participants |
| Palivizumab Registry 07/08 | Parental Cooperation in Registries 02/03 - 06/07 and 07/08 | Moderate | 221 Participants |
| Palivizumab Registry 07/08 | Parental Cooperation in Registries 02/03 - 06/07 and 07/08 | Bad/very bad | 102 Participants |
| Palivizumab Registry 07/08 | Parental Cooperation in Registries 02/03 - 06/07 and 07/08 | Very good/good | 3340 Participants |
Secondary
Presence of Complications During Hospitalization
Time frame: During RSV season (September to June) from 2002 to 2016
Population: Evaluable population who were hospitalized and with available hospitalization complication data
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Palivizumab Registry 02/03 - 06/07 | Presence of Complications During Hospitalization | Intensive care unit (ICU) admission | 111 hospitalizations |
| Palivizumab Registry 02/03 - 06/07 | Presence of Complications During Hospitalization | Oxygen supplementation required | 177 hospitalizations |
| Palivizumab Registry 02/03 - 06/07 | Presence of Complications During Hospitalization | Mechanical ventilation | 44 hospitalizations |
| Palivizumab Registry 07/08 | Presence of Complications During Hospitalization | Oxygen supplementation required | 54 hospitalizations |
| Palivizumab Registry 07/08 | Presence of Complications During Hospitalization | Intensive care unit (ICU) admission | 29 hospitalizations |
| Palivizumab Registry 07/08 | Presence of Complications During Hospitalization | Mechanical ventilation | 11 hospitalizations |
| Palivizumab Registry 08/09 | Presence of Complications During Hospitalization | Mechanical ventilation | 8 hospitalizations |
| Palivizumab Registry 08/09 | Presence of Complications During Hospitalization | Intensive care unit (ICU) admission | 22 hospitalizations |
| Palivizumab Registry 08/09 | Presence of Complications During Hospitalization | Oxygen supplementation required | 42 hospitalizations |
| Palivizumab Registry 09/10 - 15/16 | Presence of Complications During Hospitalization | Mechanical ventilation | 6 hospitalizations |
| Palivizumab Registry 09/10 - 15/16 | Presence of Complications During Hospitalization | Intensive care unit (ICU) admission | 14 hospitalizations |
| Palivizumab Registry 09/10 - 15/16 | Presence of Complications During Hospitalization | Oxygen supplementation required | 58 hospitalizations |
| Registry 09/10 - 15/16 Hospitalizations Not RSV-Associated | Presence of Complications During Hospitalization | Intensive care unit (ICU) admission | 56 hospitalizations |
| Registry 09/10 - 15/16 Hospitalizations Not RSV-Associated | Presence of Complications During Hospitalization | Oxygen supplementation required | 160 hospitalizations |
| Registry 09/10 - 15/16 Hospitalizations Not RSV-Associated | Presence of Complications During Hospitalization | Mechanical ventilation | 34 hospitalizations |