Trial Outcomes & Findings for Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease (NCT NCT01075178)

NCT ID: NCT01075178

Last Updated: 2011-03-23

Results Overview

The number of subjects who experienced at least 1 event of infection, arrhythmia, or death meeting any of the criteria for a serious adverse event

• Recruitment status: COMPLETED
• Target enrollment: 2036 participants
• Primary outcome timeframe: 8-month chart review period in CASES and CONTROLS
• Results posted on: 2011-03-23

Participant Flow

Infants diagnosed with hemodynamically significant congenital heart disease who were less than 24 months of age when first dosed with palivizumab (CASES) were compared for the occurrence of serious adverse events over an 8-month chart review period with matched infants who did not receive palivizumab during the first 24 months of life (CONTROLS).

Participant milestones

Measure	Palivizumab-treated Subjects (CASES) HSCHD infants, \<2 yrs old at first dose of palivizumab	Non-palivizumab-treated Subjects (CONTROLS) HSCHD infants, \<2 yrs old that did not receive palivizumab
Subject Matching STARTED	1148	1421
Subject Matching COMPLETED	1018	1018
Subject Matching NOT COMPLETED	130	403
Subject Chart Review STARTED	1018	1018
Subject Chart Review COMPLETED	1009	1009
Subject Chart Review NOT COMPLETED	9	9

Reasons for withdrawal

Measure	Palivizumab-treated Subjects (CASES) HSCHD infants, \<2 yrs old at first dose of palivizumab	Non-palivizumab-treated Subjects (CONTROLS) HSCHD infants, \<2 yrs old that did not receive palivizumab
Subject Matching eligible but not matched	130	403
Subject Chart Review died before chart review period	0	2
Subject Chart Review no data collected due to site closure	3	4
Subject Chart Review matched partner excluded (reasons above)	6	3

Baseline Characteristics

Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease

Baseline characteristics by cohort

Measure	Palivizumab-treated Subjects (CASES) n=1009 Participants HSCHD infants, \<2 yrs old at first dose of palivizumab	Non-palivizumab-treated Subjects (CONTROLS) n=1009 Participants HSCHD infants, \<2 yrs old that did not receive palivizumab	Total n=2018 Participants Total of all reporting groups
Age Categorical <=6 months	651 participants n=93 Participants	656 participants n=4 Participants	1307 participants n=27 Participants
Age Categorical >6 months	358 participants n=93 Participants	353 participants n=4 Participants	711 participants n=27 Participants
Age Continuous	5.4 months STANDARD_DEVIATION 4.91 • n=93 Participants	5.4 months STANDARD_DEVIATION 5.05 • n=4 Participants	5.4 months STANDARD_DEVIATION 4.98 • n=27 Participants
Sex: Female, Male Female	437 Participants n=93 Participants	462 Participants n=4 Participants	899 Participants n=27 Participants
Sex: Female, Male Male	572 Participants n=93 Participants	547 Participants n=4 Participants	1119 Participants n=27 Participants
Region of Enrollment France	188 participants n=93 Participants	211 participants n=4 Participants	399 participants n=27 Participants
Region of Enrollment Slovenia	16 participants n=93 Participants	20 participants n=4 Participants	36 participants n=27 Participants
Region of Enrollment Spain	284 participants n=93 Participants	170 participants n=4 Participants	454 participants n=27 Participants
Region of Enrollment Poland	36 participants n=93 Participants	242 participants n=4 Participants	278 participants n=27 Participants
Region of Enrollment Belgium	77 participants n=93 Participants	115 participants n=4 Participants	192 participants n=27 Participants
Region of Enrollment Austria	96 participants n=93 Participants	53 participants n=4 Participants	149 participants n=27 Participants
Region of Enrollment Norway	12 participants n=93 Participants	7 participants n=4 Participants	19 participants n=27 Participants
Region of Enrollment Germany	97 participants n=93 Participants	90 participants n=4 Participants	187 participants n=27 Participants
Region of Enrollment United Kingdom	92 participants n=93 Participants	59 participants n=4 Participants	151 participants n=27 Participants
Region of Enrollment Italy	111 participants n=93 Participants	42 participants n=4 Participants	153 participants n=27 Participants
Cardiac lesion Cyanotic	488 participants n=93 Participants	487 participants n=4 Participants	975 participants n=27 Participants
Cardiac lesion Acyanotic	521 participants n=93 Participants	522 participants n=4 Participants	1043 participants n=27 Participants
Corrective cardiac surgery None	484 participants n=93 Participants	485 participants n=4 Participants	969 participants n=27 Participants
Corrective cardiac surgery Partially corrected congenital heart disease	525 participants n=93 Participants	521 participants n=4 Participants	1046 participants n=27 Participants
Corrective cardiac surgery Fully corrected congenital heart disease	0 participants n=93 Participants	3 participants n=4 Participants	3 participants n=27 Participants

PRIMARY outcome

Timeframe: 8-month chart review period in CASES and CONTROLS

Population: The population analyzed included the full analysis set.

The number of subjects who experienced at least 1 event of infection, arrhythmia, or death meeting any of the criteria for a serious adverse event

Outcome measures

Measure	Palivizumab-treated Subjects (CASES) n=1009 Participants HSCHD infants, \<2 yrs old at first dose of palivizumab	Non-palivizumab-treated Subjects (CONTROLS) n=1009 Participants HSCHD infants, \<2 yrs old that did not receive palivizumab
Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection, Serious Arrhythmia and/or Death	303 participants	349 participants

PRIMARY outcome

Timeframe: 8-month chart review period in CASES and CONTROLS

Population: The population analyzed included the full analysis set.

The number of subjects who experienced at least 1 event of infection meeting any of the criteria for a serious adverse event

Outcome measures

Measure	Palivizumab-treated Subjects (CASES) n=1009 Participants HSCHD infants, \<2 yrs old at first dose of palivizumab	Non-palivizumab-treated Subjects (CONTROLS) n=1009 Participants HSCHD infants, \<2 yrs old that did not receive palivizumab
Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection.	281 participants	329 participants

PRIMARY outcome

Timeframe: 8-month chart review period in CASES and CONTROLS

Population: The population analyzed included the full analysis set.

The number of subjects who experienced at least 1 event of arrhythmia meeting any of the criteria for a serious adverse event

Outcome measures

Measure	Palivizumab-treated Subjects (CASES) n=1009 Participants HSCHD infants, \<2 yrs old at first dose of palivizumab	Non-palivizumab-treated Subjects (CONTROLS) n=1009 Participants HSCHD infants, \<2 yrs old that did not receive palivizumab
Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Arrhythmia	41 participants	39 participants

PRIMARY outcome

Timeframe: 8-month chart review period in CASES and CONTROLS

Population: The population analyzed included the full analysis set.

The number of subjects who died

Outcome measures

Measure	Palivizumab-treated Subjects (CASES) n=1009 Participants HSCHD infants, \<2 yrs old at first dose of palivizumab	Non-palivizumab-treated Subjects (CONTROLS) n=1009 Participants HSCHD infants, \<2 yrs old that did not receive palivizumab
Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Death	9 participants	10 participants

Adverse Events

Palivizumab-treated Subjects (CASES)

Serious events: 303 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-palivizumab-treated Subjects (CONTROLS)

Serious events: 349 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Palivizumab-treated Subjects (CASES) n=1009 participants at risk HSCHD infants, \<2 yrs old at first dose of palivizumab	Non-palivizumab-treated Subjects (CONTROLS) n=1009 participants at risk HSCHD infants, \<2 yrs old that did not receive palivizumab
Infections and infestations Pseudomonas infection	0.30% 3/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.30% 3/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Pyelonephritis	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Arrhythmia	0.40% 4/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.79% 8/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Arrhythmia supraventricular	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Atrial fibrillation	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Atrial flutter	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Atrial tachycardia	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Atrioventricular block	0.40% 4/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.30% 3/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Atrioventricular block complete	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.40% 4/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Atrioventricular block second degree	0.30% 3/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Bradycardia	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.50% 5/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Cardiac arrest	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Cardiac failure	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.50% 5/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Extrasystoles	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Myocarditis	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Nodal arrhythmia	0.59% 6/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.69% 7/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Nodal rhythm	0.40% 4/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Pericarditis	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Sinus arrhythmia	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Sinus bradycardia	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Sinus tachycardia	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Supraventricular tachycardia	0.99% 10/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.50% 5/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Tachycardia	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Ventricular tachycardia	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Congenital, familial and genetic disorders Congenital infection	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Congenital, familial and genetic disorders Congenital pneumonia	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Eye disorders Conjunctivitis	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Gastrointestinal disorders Diarrhoea	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.30% 3/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Gastrointestinal disorders Dyspepsia	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Gastrointestinal disorders Enterocolitis	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.40% 4/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Gastrointestinal disorders Gastritis	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Gastrointestinal disorders Necrotising colitis	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Gastrointestinal disorders Peritonitis	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Gastrointestinal disorders Vomiting	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
General disorders Pyrexia	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Hepatobiliary disorders Hepatitis toxic	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Acarodermatitis	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Acinetobacter infection	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Adenovirus infection	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Anal abscess	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Bacillus infection	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Bacteraemia	0.50% 5/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Bacterial infection	0.30% 3/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.30% 3/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Bronchiolitis	4.7% 47/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	4.0% 40/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Bronchitis	1.9% 19/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	3.8% 38/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Bronchitis viral	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Bronchopneumonia	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	2.2% 22/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Candida sepsis	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Candidiasis	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Candiduria	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Catheter sepsis	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Central line infection	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Clostridial infection	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Croup infectious	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Dermatitis infected	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Ear infection	0.30% 3/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Endocarditis	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Endicarditis enterococcal	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Enterobacter sepsis	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Enterocolitis infectious	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Exanthema subitum	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.30% 3/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Eye infection	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Fungal infection	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Gastric infection	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Gastroenteritis	4.2% 42/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	3.6% 36/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Gastroenteritis adenovirus	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Gastroenteritis norovirus	0.79% 8/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Gastroenteritis rotavirus	0.30% 3/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.89% 9/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Gastroenteritis salmonella	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Gastroenteritis viral	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Gastrointestinal infection	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Haemophilus infection	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Incision site abscess	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Infection	0.79% 8/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	1.5% 15/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Influenza	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Klebsiella infection	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Laryngitis	0.30% 3/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.30% 3/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Lobar pneumonia	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Lower respiratory tract infection	0.69% 7/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.59% 6/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Lower respiratory tract infection viral	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Lung infection	0.89% 9/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.69% 7/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Mediastinitis	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Meningitis	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Metapneumovirus infection	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Moraxella infection	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Nasopharyngitis	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Nosocomial infection	0.50% 5/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Oral candidiasis	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Oral herpes	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Orchitis	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Otitis externa	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Otitis media	0.30% 3/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.89% 9/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Otitis media acute	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Parainfluenza virus infection	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Pharyngitis	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.50% 5/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Pneumococcal sepsis	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Pneumocystitis jiroveci infection	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Pneumonia	3.0% 30/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	3.8% 38/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Pneumonia bacterial	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Pneumonia klebsiella	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Pneumonia streptococcal	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Pneumonia viral	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Post procedural infection	0.30% 3/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	1.4% 14/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Post procedural pneumonia	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Post procedural sepsis	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Postoperative wound infection	0.59% 6/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.40% 4/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.50% 5/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	1.7% 17/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Respiratory syncytial virus infection	0.40% 4/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.50% 5/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Respiratory tract infection	1.9% 19/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	1.9% 19/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Respiratory tract infection bacterial	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Respiratory tract infection viral	0.30% 3/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Rhinitis	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Rotavirus infection	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.40% 4/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Sepsis	2.3% 23/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	2.4% 24/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Septic shock	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Serratia infection	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Skin infection	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Staphylococcal infection	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.30% 3/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Staphylococcal sepsis	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Stenotrophomonas infection	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Systemic candida	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Tonsillitis	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Tracheitis	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.50% 5/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Tracheobronchitis	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Tracheostomy infection	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Upper respiratory tract infection	2.5% 25/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	2.3% 23/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Urinary tract infection	3.1% 31/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	3.6% 36/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Urinary tract infection bacterial	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Urosepsis	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Varicella	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Viral infection	0.79% 8/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.30% 3/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Viral tonsillitis	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Viral upper respiratory tract infection	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Wound infection	0.50% 5/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.30% 3/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Wound infection fungal	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Infections and infestations Wound infection staphylococcal	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Injury, poisoning and procedural complications Cardiac pacemaker malfunction	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Investigations Clostridium difficile toxin test	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Investigations Respiratory syncytial virus test positive	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Metabolism and nutrition disorders Dehydration	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Nervous system disorders Febrile convulsion	0.20% 2/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Nervous system disorders Syncope	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.40% 4/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Skin and subcutaneous tissue disorders Hangnail	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Cardiogenic shock	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Cardiac disorders Congestive cardiomyopathy	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Congenital, familial and genetic disorders Heart disease congenital	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Congenital, familial and genetic disorders Hypoplastic left heart syndrome	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Immune system disorders Heart transplant rejection	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
Vascular disorders Haemodynamic instability	0.10% 1/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.	0.00% 0/1009 • 8-month chart review period Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.

Other adverse events

Adverse event data not reported

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