Trial Outcomes & Findings for Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany (NCT NCT01155193)
NCT ID: NCT01155193
Last Updated: 2018-10-29
Results Overview
Recruitment status
COMPLETED
Target enrollment
30804 participants
Primary outcome timeframe
During RSV season (September to June) from 2002 to 2016
Results posted on
2018-10-29
Participant Flow
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.
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
Participant milestones
| Measure |
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 until 30 June 2007.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10924
|
3818
|
2260
|
13802
|
|
Overall Study
COMPLETED
|
10686
|
3805
|
2248
|
13711
|
|
Overall Study
NOT COMPLETED
|
238
|
13
|
12
|
91
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data are reported where available. Data are reported separately for different registry phases as no overall analysis was performed.
Baseline characteristics by cohort
| Measure |
Palivizumab Registry 02/03 - 06/07
n=10686 Participants
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.
|
Palivizumab Registry 07/08
n=3805 Participants
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.
|
Palivizumab Registry 08/09
n=2248 Participants
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.
|
Palivizumab Registry 09/10 - 15/16
n=12729 Participants
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.
|
Total
n=29468 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
< 29 weeks
|
3582 Participants
n=10686 Participants
|
1173 Participants
n=3805 Participants
|
694 Participants
n=2248 Participants
|
3514 Participants
n=12729 Participants
|
8963 Participants
n=29468 Participants
|
|
Age, Customized
29 to < 33 weeks
|
3385 Participants
n=10686 Participants
|
1161 Participants
n=3805 Participants
|
705 Participants
n=2248 Participants
|
4033 Participants
n=12729 Participants
|
9284 Participants
n=29468 Participants
|
|
Age, Customized
33 to ≤ 35 weeks
|
1500 Participants
n=10686 Participants
|
578 Participants
n=3805 Participants
|
474 Participants
n=2248 Participants
|
3237 Participants
n=12729 Participants
|
5789 Participants
n=29468 Participants
|
|
Age, Customized
> 35 weeks
|
481 Participants
n=10686 Participants
|
164 Participants
n=3805 Participants
|
375 Participants
n=2248 Participants
|
1945 Participants
n=12729 Participants
|
2965 Participants
n=29468 Participants
|
|
Age, Customized
Missing
|
1738 Participants
n=10686 Participants
|
729 Participants
n=3805 Participants
|
0 Participants
n=2248 Participants
|
0 Participants
n=12729 Participants
|
2467 Participants
n=29468 Participants
|
|
Sex/Gender, Customized
Female
|
4901 Participants
n=10686 Participants
|
1737 Participants
n=3805 Participants
|
1019 Participants
n=2248 Participants
|
5707 Participants
n=12729 Participants
|
13364 Participants
n=29468 Participants
|
|
Sex/Gender, Customized
Male
|
5716 Participants
n=10686 Participants
|
2051 Participants
n=3805 Participants
|
1229 Participants
n=2248 Participants
|
7013 Participants
n=12729 Participants
|
16009 Participants
n=29468 Participants
|
|
Sex/Gender, Customized
Missing
|
69 Participants
n=10686 Participants
|
17 Participants
n=3805 Participants
|
0 Participants
n=2248 Participants
|
9 Participants
n=12729 Participants
|
95 Participants
n=29468 Participants
|
|
Birth Weight
< 1000 g
|
3283 Participants
n=10686 Participants
|
1101 Participants
n=3805 Participants
|
595 Participants
n=2248 Participants
|
2946 Participants
n=12729 Participants
|
7925 Participants
n=29468 Participants
|
|
Birth Weight
1000 - 1499 g
|
2782 Participants
n=10686 Participants
|
965 Participants
n=3805 Participants
|
538 Participants
n=2248 Participants
|
3063 Participants
n=12729 Participants
|
7348 Participants
n=29468 Participants
|
|
Birth Weight
1500 - 1999 g
|
1788 Participants
n=10686 Participants
|
659 Participants
n=3805 Participants
|
424 Participants
n=2248 Participants
|
2590 Participants
n=12729 Participants
|
5461 Participants
n=29468 Participants
|
|
Birth Weight
≥ 2000 g
|
2595 Participants
n=10686 Participants
|
995 Participants
n=3805 Participants
|
691 Participants
n=2248 Participants
|
4130 Participants
n=12729 Participants
|
8411 Participants
n=29468 Participants
|
|
Birth Weight
Missing
|
238 Participants
n=10686 Participants
|
85 Participants
n=3805 Participants
|
0 Participants
n=2248 Participants
|
0 Participants
n=12729 Participants
|
323 Participants
n=29468 Participants
|
|
Age at Start of Immunoprophylaxis
Registry 02/03 - 06/07
|
5.2 months
STANDARD_DEVIATION 4.0 • n=10059 Participants • Data are reported where available. Data are reported separately for different registry phases as no overall analysis was performed.
|
—
|
—
|
—
|
5.2 months
STANDARD_DEVIATION 4.0 • n=10059 Participants • Data are reported where available. Data are reported separately for different registry phases as no overall analysis was performed.
|
|
Age at Start of Immunoprophylaxis
Registry 07/08
|
—
|
5.0 months
STANDARD_DEVIATION 4.0 • n=3578 Participants • Data are reported where available. Data are reported separately for different registry phases as no overall analysis was performed.
|
—
|
—
|
5.0 months
STANDARD_DEVIATION 4.0 • n=3578 Participants • Data are reported where available. Data are reported separately for different registry phases as no overall analysis was performed.
|
|
Age at Start of Immunoprophylaxis
Registry 08/09
|
—
|
—
|
5.9 months
STANDARD_DEVIATION 4.9 • n=2248 Participants • Data are reported where available. Data are reported separately for different registry phases as no overall analysis was performed.
|
—
|
5.9 months
STANDARD_DEVIATION 4.9 • n=2248 Participants • Data are reported where available. Data are reported separately for different registry phases as no overall analysis was performed.
|
|
Age at Start of Immunoprophylaxis
Registry 09/10 - 15/16
|
—
|
—
|
—
|
4.3 months
STANDARD_DEVIATION 3.6 • n=12729 Participants • Data are reported where available. Data are reported separately for different registry phases as no overall analysis was performed.
|
4.3 months
STANDARD_DEVIATION 3.6 • n=12729 Participants • Data are reported where available. Data are reported separately for different registry phases as no overall analysis was performed.
|
|
Risk Factors for RSV Complications
Premature birth (< 29 weeks GA)
|
3582 Participants
n=8948 Participants • Data are reported where available
|
1173 Participants
n=3076 Participants • Data are reported where available
|
694 Participants
n=2248 Participants • Data are reported where available
|
3514 Participants
n=12729 Participants • Data are reported where available
|
8963 Participants
n=27001 Participants • Data are reported where available
|
|
Risk Factors for RSV Complications
Premature birth (≤ 35 weeks GA)
|
8467 Participants
n=8948 Participants • Data are reported where available
|
2912 Participants
n=3076 Participants • Data are reported where available
|
1873 Participants
n=2248 Participants • Data are reported where available
|
10784 Participants
n=12729 Participants • Data are reported where available
|
24036 Participants
n=27001 Participants • Data are reported where available
|
|
Risk Factors for RSV Complications
Multiple births
|
2607 Participants
n=9752 Participants • Data are reported where available
|
922 Participants
n=3771 Participants • Data are reported where available
|
632 Participants
n=2141 Participants • Data are reported where available
|
3793 Participants
n=12147 Participants • Data are reported where available
|
7954 Participants
n=27811 Participants • Data are reported where available
|
|
Risk Factors for RSV Complications
Congenital heart disease
|
3001 Participants
n=9588 Participants • Data are reported where available
|
1283 Participants
n=3677 Participants • Data are reported where available
|
567 Participants
n=2248 Participants • Data are reported where available
|
3430 Participants
n=12544 Participants • Data are reported where available
|
8281 Participants
n=28057 Participants • Data are reported where available
|
|
Risk Factors for RSV Complications
Smoking in the family
|
1422 Participants
n=8043 Participants • Data are reported where available
|
482 Participants
n=3031 Participants • Data are reported where available
|
400 Participants
n=2248 Participants • Data are reported where available
|
2037 Participants
n=6332 Participants • Data are reported where available
|
4341 Participants
n=19654 Participants • Data are reported where available
|
|
Risk Factors for RSV Complications
Chronic lung disease
|
4179 Participants
n=9805 Participants • Data are reported where available
|
1330 Participants
n=3501 Participants • Data are reported where available
|
584 Participants
n=2248 Participants • Data are reported where available
|
2346 Participants
n=12422 Participants • Data are reported where available
|
8439 Participants
n=27976 Participants • Data are reported where available
|
|
Risk Factors for RSV Complications
Immunodeficiency
|
430 Participants
n=8875 Participants • Data are reported where available
|
167 Participants
n=3428 Participants • Data are reported where available
|
30 Participants
n=2248 Participants • Data are reported where available
|
171 Participants
n=12271 Participants • Data are reported where available
|
798 Participants
n=26822 Participants • Data are reported where available
|
|
Risk Factors for RSV Complications
Attending daycare
|
240 Participants
n=9722 Participants • Data are reported where available
|
109 Participants
n=3745 Participants • Data are reported where available
|
74 Participants
n=2248 Participants • Data are reported where available
|
361 Participants
n=12389 Participants • Data are reported where available
|
784 Participants
n=28104 Participants • Data are reported where available
|
|
Risk Factors for RSV Complications
Other children (< 12 years) in household
|
4440 Participants
n=9662 Participants • Data are reported where available
|
1682 Participants
n=3728 Participants • Data are reported where available
|
1115 Participants
n=2248 Participants • Data are reported where available
|
4899 Participants
n=10767 Participants • Data are reported where available
|
12136 Participants
n=26405 Participants • Data are reported where available
|
|
Risk Factors for RSV Complications
Family history of asthma
|
823 Participants
n=7877 Participants • Data are reported where available
|
304 Participants
n=2956 Participants • Data are reported where available
|
NA Participants
n=2248 Participants • Data are reported where available
|
1128 Participants
n=10589 Participants • Data are reported where available
|
NA Participants
n=23670 Participants • Data are reported where available
|
|
Risk Factors for RSV Complications
Family history of allergic rhinitis
|
1234 Participants
n=7819 Participants • Data are reported where available
|
450 Participants
n=2920 Participants • Data are reported where available
|
NA Participants
n=2248 Participants • Data are reported where available
|
NA Participants
n=12729 Participants • Data are reported where available
|
NA Participants
n=25716 Participants • Data are reported where available
|
|
Risk Factors for RSV Complications
Family history of allergic eczema
|
713 Participants
n=7751 Participants • Data are reported where available
|
245 Participants
n=2889 Participants • Data are reported where available
|
NA Participants
n=2248 Participants • Data are reported where available
|
NA Participants
n=12729 Participants • Data are reported where available
|
NA Participants
n=25617 Participants • Data are reported where available
|
|
Risk Factors for RSV Complications
Family history of atopy
|
NA Participants
n=10686 Participants • Data are reported where available
|
NA Participants
n=3805 Participants • Data are reported where available
|
346 Participants
n=2248 Participants • Data are reported where available
|
2039 Participants
n=10606 Participants • Data are reported where available
|
NA Participants
n=27345 Participants • Data are reported where available
|
|
Risk Factors for RSV Complications
Cyanotic heart defect
|
NA Participants
n=10686 Participants • Data are reported where available
|
NA Participants
n=3805 Participants • Data are reported where available
|
123 Participants
n=2248 Participants • Data are reported where available
|
784 Participants
n=12363 Participants • Data are reported where available
|
NA Participants
n=29102 Participants • Data are reported where available
|
|
Risk Factors for RSV Complications
Chronic lung disease therapy
|
NA Participants
n=10686 Participants • Data are reported where available
|
NA Participants
n=3805 Participants • Data are reported where available
|
281 Participants
n=2248 Participants • Data are reported where available
|
1803 Participants
n=12291 Participants • Data are reported where available
|
NA Participants
n=29030 Participants • Data are reported where available
|
|
Risk Factors for RSV Complications
Treatment with oxygen at home
|
NA Participants
n=10686 Participants • Data are reported where available
|
NA Participants
n=3805 Participants • Data are reported where available
|
133 Participants
n=2248 Participants • Data are reported where available
|
763 Participants
n=12490 Participants • Data are reported where available
|
NA Participants
n=29229 Participants • Data are reported where available
|
|
Risk Factors for RSV Complications
Neuromuscular impairment
|
NA Participants
n=10686 Participants • Data are reported where available
|
NA Participants
n=3805 Participants • Data are reported where available
|
120 Participants
n=2248 Participants • Data are reported where available
|
786 Participants
n=8435 Participants • Data are reported where available
|
NA Participants
n=25174 Participants • Data are reported where available
|
|
Risk Factors for RSV Complications
Down syndrome (Trisomy 21)
|
NA Participants
n=10686 Participants • Data are reported where available
|
NA Participants
n=3805 Participants • Data are reported where available
|
NA Participants
n=2248 Participants • Data are reported where available
|
249 Participants
n=12729 Participants • Data are reported where available
|
NA Participants
n=29468 Participants • Data are reported where available
|
|
Risk Factors for RSV Complications
Serious neurological disease
|
NA Participants
n=10686 Participants • Data are reported where available
|
NA Participants
n=3805 Participants • Data are reported where available
|
NA Participants
n=2248 Participants • Data are reported where available
|
428 Participants
n=8393 Participants • Data are reported where available
|
NA Participants
n=25132 Participants • Data are reported where available
|
|
Risk Factors for RSV Complications
Low social status
|
NA Participants
n=10686 Participants • Data are reported where available
|
NA Participants
n=3805 Participants • Data are reported where available
|
NA Participants
n=2248 Participants • Data are reported where available
|
2258 Participants
n=11915 Participants • Data are reported where available
|
NA Participants
n=28654 Participants • Data are reported where available
|
|
Risk Factors for RSV Complications
Crowded living conditions
|
NA Participants
n=10686 Participants • Data are reported where available
|
NA Participants
n=3805 Participants • Data are reported where available
|
NA Participants
n=2248 Participants • Data are reported where available
|
2592 Participants
n=10575 Participants • Data are reported where available
|
NA Participants
n=27314 Participants • Data are reported where available
|
|
Risk Factors for RSV Complications
Exposition to air pollution
|
NA Participants
n=10686 Participants • Data are reported where available
|
NA Participants
n=3805 Participants • Data are reported where available
|
NA Participants
n=2248 Participants • Data are reported where available
|
1710 Participants
n=10960 Participants • Data are reported where available
|
NA Participants
n=27699 Participants • Data are reported where available
|
|
Risk Factors for RSV Complications
Breast feeding ≤ 2 months
|
NA Participants
n=10686 Participants • Data are reported where available
|
NA Participants
n=3805 Participants • Data are reported where available
|
NA Participants
n=2248 Participants • Data are reported where available
|
5794 Participants
n=11417 Participants • Data are reported where available
|
NA Participants
n=28156 Participants • Data are reported where available
|
|
Immunoprophylaxis with Palivizumab Started in Hospital
|
1645 Participants
n=10544 Participants • Data are reported where available
|
519 Participants
n=3745 Participants • Data are reported where available
|
313 Participants
n=1798 Participants • Data are reported where available
|
3127 Participants
n=12729 Participants • Data are reported where available
|
5604 Participants
n=28816 Participants • Data are reported where available
|
PRIMARY outcome
Timeframe: During RSV season (September to June) from 2002 to 2016Population: Evaluable population with available hospitalization data
Outcome measures
| Measure |
Palivizumab Registry 02/03 - 06/07
n=9833 Participants
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.
|
Palivizumab Registry 07/08
n=3805 Participants
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.
|
Palivizumab Registry 08/09
n=2248 Participants
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.
|
Palivizumab Registry 09/10 - 15/16
n=12729 Participants
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.
|
Registry 09/10 - 15/16 Hospitalizations Not RSV-Associated
Participants who were prescribed palivizumab (Synagis®) prophylaxis according to the German SPC for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016, and had a hospitalization that was not associated with RSV infection.
|
|---|---|---|---|---|---|
|
Percentage of Participants With RSV-associated Hospitalization
|
1.5 percentage of participants
|
1.5 percentage of participants
|
0.8 percentage of participants
|
0.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: During RSV season (September to June) from 2002 to 2008Population: Participants in registries 02/03 - 06/07 and 07/08 who were hospitalized, and hospitalization was documented on paper case report forms.
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.
Outcome measures
| Measure |
Palivizumab Registry 02/03 - 06/07
n=334 hospitalizations
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.
|
Palivizumab Registry 07/08
n=121 hospitalizations
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.
|
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.
|
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.
|
Registry 09/10 - 15/16 Hospitalizations Not RSV-Associated
Participants who were prescribed palivizumab (Synagis®) prophylaxis according to the German SPC for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016, and had a hospitalization that was not associated with RSV infection.
|
|---|---|---|---|---|---|
|
Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08
Bronchiolitis
|
67 hospitalizations
|
18 hospitalizations
|
—
|
—
|
—
|
|
Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08
RSV-Bronchiolitis
|
99 hospitalizations
|
34 hospitalizations
|
—
|
—
|
—
|
|
Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08
Pneumonia (Viral pneumonia)
|
26 hospitalizations
|
12 hospitalizations
|
—
|
—
|
—
|
|
Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08
RSV-Pneumonia
|
44 hospitalizations
|
14 hospitalizations
|
—
|
—
|
—
|
|
Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08
RSV-Infection
|
49 hospitalizations
|
26 hospitalizations
|
—
|
—
|
—
|
|
Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08
Other
|
134 hospitalizations
|
70 hospitalizations
|
—
|
—
|
—
|
|
Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08
Any RSV diagnosis
|
154 hospitalizations
|
57 hospitalizations
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During RSV season (September to June) from 2008 to 2016Population: 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)
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.
Outcome measures
| Measure |
Palivizumab Registry 02/03 - 06/07
n=90 hospitalizations
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.
|
Palivizumab Registry 07/08
n=85 hospitalizations
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.
|
Palivizumab Registry 08/09
n=220 hospitalizations
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.
|
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.
|
Registry 09/10 - 15/16 Hospitalizations Not RSV-Associated
Participants who were prescribed palivizumab (Synagis®) prophylaxis according to the German SPC for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016, and had a hospitalization that was not associated with RSV infection.
|
|---|---|---|---|---|---|
|
Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16
Bronchitis
|
24 hospitalizations
|
24 hospitalizations
|
115 hospitalizations
|
—
|
—
|
|
Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16
Bronchiolitis
|
4 hospitalizations
|
32 hospitalizations
|
15 hospitalizations
|
—
|
—
|
|
Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16
Pneumonia (clinical diagnosis)
|
7 hospitalizations
|
9 hospitalizations
|
27 hospitalizations
|
—
|
—
|
|
Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16
Pneumonia (confirmed by chest radiography)
|
18 hospitalizations
|
19 hospitalizations
|
58 hospitalizations
|
—
|
—
|
|
Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16
Acute respiratory failure
|
3 hospitalizations
|
1 hospitalizations
|
3 hospitalizations
|
—
|
—
|
|
Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16
Apnoea-bradycardia syndrome
|
1 hospitalizations
|
0 hospitalizations
|
2 hospitalizations
|
—
|
—
|
|
Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16
Not specified
|
33 hospitalizations
|
0 hospitalizations
|
0 hospitalizations
|
—
|
—
|
SECONDARY outcome
Timeframe: During RSV season (September to June) from 2002 to 2016Population: Evaluable population who were hospitalized and with available hospitalization complication data
Outcome measures
| Measure |
Palivizumab Registry 02/03 - 06/07
n=334 hospitalizations
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.
|
Palivizumab Registry 07/08
n=121 hospitalizations
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.
|
Palivizumab Registry 08/09
n=90 hospitalizations
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.
|
Palivizumab Registry 09/10 - 15/16
n=92 hospitalizations
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.
|
Registry 09/10 - 15/16 Hospitalizations Not RSV-Associated
n=356 hospitalizations
Participants who were prescribed palivizumab (Synagis®) prophylaxis according to the German SPC for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016, and had a hospitalization that was not associated with RSV infection.
|
|---|---|---|---|---|---|
|
Presence of Complications During Hospitalization
Mechanical ventilation
|
44 hospitalizations
|
11 hospitalizations
|
8 hospitalizations
|
6 hospitalizations
|
34 hospitalizations
|
|
Presence of Complications During Hospitalization
Intensive care unit (ICU) admission
|
111 hospitalizations
|
29 hospitalizations
|
22 hospitalizations
|
14 hospitalizations
|
56 hospitalizations
|
|
Presence of Complications During Hospitalization
Oxygen supplementation required
|
177 hospitalizations
|
54 hospitalizations
|
42 hospitalizations
|
58 hospitalizations
|
160 hospitalizations
|
SECONDARY outcome
Timeframe: During RSV season (September to June) from 2002 to 2008Population: Evaluable population 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.
Outcome measures
| Measure |
Palivizumab Registry 02/03 - 06/07
n=10686 Participants
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.
|
Palivizumab Registry 07/08
n=3805 Participants
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.
|
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.
|
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.
|
Registry 09/10 - 15/16 Hospitalizations Not RSV-Associated
Participants who were prescribed palivizumab (Synagis®) prophylaxis according to the German SPC for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016, and had a hospitalization that was not associated with RSV infection.
|
|---|---|---|---|---|---|
|
Parental Cooperation in Registries 02/03 - 06/07 and 07/08
Very good/good
|
9383 Participants
|
3340 Participants
|
—
|
—
|
—
|
|
Parental Cooperation in Registries 02/03 - 06/07 and 07/08
Moderate
|
567 Participants
|
221 Participants
|
—
|
—
|
—
|
|
Parental Cooperation in Registries 02/03 - 06/07 and 07/08
Bad/very bad
|
354 Participants
|
102 Participants
|
—
|
—
|
—
|
|
Parental Cooperation in Registries 02/03 - 06/07 and 07/08
Missing
|
382 Participants
|
142 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During RSV season (September to June) from 2008 to 2016Population: 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.
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.
Outcome measures
| Measure |
Palivizumab Registry 02/03 - 06/07
n=11039 Palivizumab injections
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.
|
Palivizumab Registry 07/08
n=63572 Palivizumab injections
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.
|
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.
|
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.
|
Registry 09/10 - 15/16 Hospitalizations Not RSV-Associated
Participants who were prescribed palivizumab (Synagis®) prophylaxis according to the German SPC for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016, and had a hospitalization that was not associated with RSV infection.
|
|---|---|---|---|---|---|
|
Parental Cooperation for Registry 08/09 and 09/10 - 15/16
Good
|
8175 Palivizumab injections
|
51408 Palivizumab injections
|
—
|
—
|
—
|
|
Parental Cooperation for Registry 08/09 and 09/10 - 15/16
Satisfying
|
550 Palivizumab injections
|
2985 Palivizumab injections
|
—
|
—
|
—
|
|
Parental Cooperation for Registry 08/09 and 09/10 - 15/16
Bad
|
143 Palivizumab injections
|
575 Palivizumab injections
|
—
|
—
|
—
|
|
Parental Cooperation for Registry 08/09 and 09/10 - 15/16
Missing
|
2171 Palivizumab injections
|
8604 Palivizumab injections
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During RSV season (September to June) from 2002 to 2016Population: Evaluable population; for registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
The mean number of palivizumab injections per participant, per season.
Outcome measures
| Measure |
Palivizumab Registry 02/03 - 06/07
n=10686 Participants
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.
|
Palivizumab Registry 07/08
n=3805 Participants
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.
|
Palivizumab Registry 08/09
n=2248 Participants
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.
|
Palivizumab Registry 09/10 - 15/16
n=12729 Participants
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.
|
Registry 09/10 - 15/16 Hospitalizations Not RSV-Associated
Participants who were prescribed palivizumab (Synagis®) prophylaxis according to the German SPC for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016, and had a hospitalization that was not associated with RSV infection.
|
|---|---|---|---|---|---|
|
Mean Number of Palivizumab Injections
|
4.7 palivizumab injections
Standard Deviation 1.8
|
4.8 palivizumab injections
Standard Deviation 1.9
|
4.9 palivizumab injections
Standard Deviation 2.0
|
5.0 palivizumab injections
Standard Deviation 2.0
|
—
|
Adverse Events
Palivizumab
Serious events: 701 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Palivizumab
n=29468 participants at risk
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 (September to June) from 2002 to 2016.
|
|---|---|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.01%
3/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Cardiac disorders
AORTIC VALVE STENOSIS
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Cardiac disorders
BRADYCARDIA
|
0.01%
3/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.01%
2/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Cardiac disorders
CARDIAC DISORDER
|
0.01%
2/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.01%
2/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Cardiac disorders
CARDIOPULMONARY FAILURE
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Cardiac disorders
CARDIOVASCULAR INSUFFICIENCY
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Cardiac disorders
CYANOSIS
|
0.01%
4/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Cardiac disorders
MYOCARDITIS
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Cardiac disorders
RESTRICTIVE CARDIOMYOPATHY
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Cardiac disorders
RIGHT VENTRICULAR DYSFUNCTION
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Congenital, familial and genetic disorders
ATRIAL SEPTAL DEFECT
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Congenital, familial and genetic disorders
CONGENITAL CENTRAL HYPOVENTILATION SYNDROME
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Congenital, familial and genetic disorders
FALLOT'S TETRALOGY
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Congenital, familial and genetic disorders
HEART DISEASE CONGENITAL
|
0.01%
2/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Congenital, familial and genetic disorders
HYPOPLASTIC LEFT HEART SYNDROME
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Congenital, familial and genetic disorders
LISSENCEPHALY
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Congenital, familial and genetic disorders
WOLF-HIRSCHHORN SYNDROME
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Gastrointestinal disorders
DIAPHRAGMATIC HERNIA
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.01%
3/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Gastrointestinal disorders
NECROTISING COLITIS
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Gastrointestinal disorders
VOMITING
|
0.01%
4/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
General disorders
ADVERSE DRUG REACTION
|
0.02%
6/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
General disorders
ADVERSE EVENT
|
0.01%
2/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
General disorders
CARDIAC DEATH
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
General disorders
DEATH
|
0.04%
12/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.04%
12/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
General disorders
HYPOTHERMIA
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
General disorders
MALAISE
|
0.01%
2/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
General disorders
OEDEMA
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
General disorders
PYREXIA
|
0.07%
21/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
ADENOVIRAL UPPER RESPIRATORY INFECTION
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
BRONCHIOLITIS
|
0.11%
31/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
BRONCHITIS
|
0.42%
124/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
BRONCHITIS VIRAL
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
CELLULITIS
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
CONJUNCTIVITIS
|
0.01%
3/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
DEVICE RELATED SEPSIS
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
EXANTHEMA SUBITUM
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
GASTROENTERITIS
|
0.02%
7/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
GASTROENTERITIS NOROVIRUS
|
0.01%
3/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
GASTROENTERITIS ROTAVIRUS
|
0.01%
2/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
INFECTION
|
0.01%
3/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
INFECTIVE PERICARDIAL EFFUSION
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
INFLUENZA
|
0.01%
3/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
LARYNGOTRACHEITIS OBSTRUCTIVE
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
MYELITIS
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.02%
7/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
OSTEOMYELITIS
|
0.01%
2/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
OTITIS MEDIA
|
0.01%
3/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
PERTUSSIS
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
PNEUMONIA
|
0.36%
105/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
PNEUMONIA ESCHERICHIA
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
PNEUMONIA INFLUENZAL
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL
|
0.17%
51/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.06%
18/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
PSEUDOCROUP
|
0.01%
4/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS
|
0.29%
85/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS BRONCHITIS
|
0.10%
30/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS INFECTION
|
0.15%
44/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.06%
19/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
0.01%
3/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
SEPSIS
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
SUPERINFECTION BACTERIAL
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.04%
12/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
VIRAL INFECTION
|
0.02%
5/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Injury, poisoning and procedural complications
INJECTION RELATED REACTION
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Investigations
ANTIMICROBIAL SUSCEPTIBILITY TEST RESISTANT
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Investigations
BODY TEMPERATURE INCREASED
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Investigations
BREATH SOUNDS ABNORMAL
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Investigations
CATHETERISATION CARDIAC
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Investigations
INFLUENZA VIRUS TEST POSITIVE
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Investigations
OXYGEN SATURATION DECREASED
|
0.02%
7/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Investigations
RESPIRATORY SYNCYTIAL VIRUS TEST POSITIVE
|
0.03%
8/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Investigations
STAPHYLOCOCCUS TEST POSITIVE
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Investigations
WEIGHT DECREASED
|
0.01%
2/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.01%
3/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Metabolism and nutrition disorders
DIET REFUSAL
|
0.02%
6/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
0.01%
4/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Metabolism and nutrition disorders
FLUID INTAKE REDUCED
|
0.02%
7/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Metabolism and nutrition disorders
LACTOSE INTOLERANCE
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
0.01%
2/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HAEMANGIOMA
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HISTIOCYTOSIS
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Nervous system disorders
ALTERED STATE OF CONSCIOUSNESS
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Nervous system disorders
FEBRILE CONVULSION
|
0.02%
5/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Nervous system disorders
HYDROCEPHALUS
|
0.01%
3/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Nervous system disorders
INFANTILE SPASMS
|
0.01%
2/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Nervous system disorders
SEIZURE
|
0.02%
5/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Pregnancy, puerperium and perinatal conditions
NEONATAL DISORDER
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Pregnancy, puerperium and perinatal conditions
POOR WEIGHT GAIN NEONATAL
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Psychiatric disorders
APATHY
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Psychiatric disorders
RESTLESSNESS
|
0.01%
2/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Renal and urinary disorders
RENAL DISORDER
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.02%
5/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
APNOEA
|
0.03%
8/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
APPARENT LIFE THREATENING EVENT
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
ASPIRATION
|
0.01%
2/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL HYPERREACTIVITY
|
0.01%
2/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL OBSTRUCTION
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHITIS CHRONIC
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOPULMONARY DYSPLASIA
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.04%
13/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.05%
15/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
HYPERCAPNIA
|
0.01%
2/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.01%
2/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
INFANTILE APNOEA
|
0.01%
3/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
IRREGULAR BREATHING
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL STENOSIS
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
NEONATAL HYPOXIA
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
OBSTRUCTIVE AIRWAYS DISORDER
|
0.01%
3/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
RALES
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISORDER
|
0.04%
12/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.05%
16/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
TACHYPNOEA
|
0.01%
2/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Skin and subcutaneous tissue disorders
ECZEMA INFANTILE
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Surgical and medical procedures
CARDIAC OPERATION
|
0.02%
7/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Surgical and medical procedures
ELECTIVE PROCEDURE
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Surgical and medical procedures
ENTEROSTOMY
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Surgical and medical procedures
HERNIA REPAIR
|
0.01%
3/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Surgical and medical procedures
HOSPITALISATION
|
0.39%
114/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Surgical and medical procedures
ILEOSTOMY CLOSURE
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Surgical and medical procedures
IMMUNISATION
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Surgical and medical procedures
OXYGEN SUPPLEMENTATION
|
0.03%
9/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Surgical and medical procedures
PHARYNGEAL RECONSTRUCTION
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Surgical and medical procedures
PLASTIC SURGERY OF THE LIPS AND MOUTH
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Surgical and medical procedures
PULMONARY VALVE REPAIR
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Vascular disorders
AORTIC STENOSIS
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
Other adverse events
| Measure |
Palivizumab
n=29468 participants at risk
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 (September to June) from 2002 to 2016.
|
|---|---|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Cardiac disorders
CARDIOVASCULAR DISORDER
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Cardiac disorders
CYANOSIS
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Congenital, familial and genetic disorders
HEART DISEASE CONGENITAL
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.01%
3/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
General disorders
ADMINISTRATION SITE REACTION
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
General disorders
ADVERSE DRUG REACTION
|
0.01%
2/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
General disorders
ADVERSE EVENT
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
General disorders
DRUG INEFFECTIVE
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
General disorders
IRRITABILITY POSTVACCINAL
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
General disorders
PERIPHERAL SWELLING
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
General disorders
PYREXIA
|
0.02%
6/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
General disorders
VACCINATION SITE REACTION
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
BRONCHITIS
|
0.01%
3/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
BRUCELLOSIS
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
INFECTION
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS BRONCHITIS
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS INFECTION
|
0.01%
3/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Injury, poisoning and procedural complications
VACCINATION COMPLICATION
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Metabolism and nutrition disorders
DIET REFUSAL
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Metabolism and nutrition disorders
FEEDING DISORDER
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Psychiatric disorders
PERSONALITY CHANGE
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Psychiatric disorders
RESTLESSNESS
|
0.01%
2/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Psychiatric disorders
SCREAMING
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL OBSTRUCTION
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.01%
3/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
|
Surgical and medical procedures
HOSPITALISATION
|
0.00%
1/29468 • During RSV season (June to September) from 2002 to 2016
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
|
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