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A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children

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ClinicalTrials.gov Identifier: NCT03959488
Recruitment Status : Completed
First Posted : May 22, 2019
Results First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Respiratory Syncytial Virus Infections
Interventions Drug: MEDI8897
Drug: Palivizumab
Enrollment 925
Recruitment Details In the overall population, 925 infants (615 in preterm cohort, 310 in CLD/CHD cohort) were enrolled from 25 countries and randomized (2:1) to MEDI8897 (n = 616) or palivizumab (n = 309). Of the 310 subjects in the Season 1 CLD/CHD cohort, 262 continued into the Season 2 phase of the study.
Pre-assignment Details  
Arm/Group Title MEDI8897 Palivizumab MEDI8897/MEDI8897 Palivizumab/MEDI8897 Palivizumab/Palivizumab
Hide Arm/Group Description Subjects who were randomized to MEDI8897 group in Season 1 Subjects who were randomized to Palivizumab group in Season 1 CHD/CLD subjects who were randomized to MEDI8897 group in Season 1 and remained in MEDI8897 group in Season 2. CHD/CLD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to MEDI8897 group in Season 2 CLD/CHD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to Palivizumab group in Season 2
Period Title: Season 1
Started 616 309 0 0 0
Completed 543 263 0 0 0
Not Completed 73 46 0 0 0
Reason Not Completed
Other             6             7             0             0             0
Withdrawal by parent/guardian             43             28             0             0             0
Due to COVID-19 pandemic             2             3             0             0             0
Lost to Follow-up             17             7             0             0             0
Death             5             1             0             0             0
Period Title: Season 2
Started [1] 0 0 180 40 42
Completed 0 0 174 39 40
Not Completed 0 0 6 1 2
Reason Not Completed
Other             0             0             2             0             0
Withdrawal by parent/guardian             0             0             3             1             1
Lost to Follow-up             0             0             1             0             1
[1]
Only CHD/CLD subjects who completed Season 1 continued into Season 2 phase of the study
Arm/Group Title MEDI8897 Palivizumab MEDI8897/MEDI8897 Palivizumab/MEDI8897 Palivizumab/Palivizumab Total
Hide Arm/Group Description Subjects who were randomized to MEDI8897 group in Season 1 Subjects who were randomized to Palivizumab group in Season 1 CHD/CLD subjects who were randomized to MEDI8897 group in Season 1 and remained in MEDI8897 group in Season 2. CHD/CLD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to MEDI8897 group in Season 2 CLD/CHD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to Palivizumab group in Season 2 Total of all reporting groups
Overall Number of Baseline Participants 616 309 180 40 42 1187
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Months
Age at randomization (months) Number Analyzed 616 participants 309 participants 0 participants 0 participants 0 participants 925 participants
3.947  (2.5513) 3.840  (2.4608) 3.911  (2.5206)
[1]
Measure Description: Age at Season 1 randomization for Season 1 participants
[2]
Measure Analysis Population Description: This summary is for Season 1 participants only
Age, Continuous   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Months
Age at first dose of Season 2 (Months) Number Analyzed 0 participants 0 participants 180 participants 40 participants 42 participants 262 participants
16.772  (2.7141) 16.598  (2.4335) 16.132  (2.1040) 16.643  (2.5857)
[1]
Measure Description: Age at first dose of Season 2 for Season 2 participants
[2]
Measure Analysis Population Description: This summary is for Season 2 participants only
Sex: Female, Male   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 616 participants 309 participants 0 participants 0 participants 0 participants 925 participants
Female
297
  48.2%
133
  43.0%
0 0 0
430
  46.5%
Male
319
  51.8%
176
  57.0%
0 0 0
495
  53.5%
[1]
Measure Description: Sex summary for Season 1 participants
[2]
Measure Analysis Population Description: Sex summary for Season 1 participants
Sex: Female, Male   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 180 participants 40 participants 42 participants 262 participants
Female 0 0
81
  45.0%
15
  37.5%
15
  35.7%
111
  42.4%
Male 0 0
99
  55.0%
25
  62.5%
27
  64.3%
151
  57.6%
[1]
Measure Description: Sex summary for Season 2 participants
[2]
Measure Analysis Population Description: Sex summary for Season 2 participants only
Race (NIH/OMB)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 616 participants 309 participants 0 participants 0 participants 0 participants 925 participants
American Indian or Alaska Native
11
   1.8%
5
   1.6%
0 0 0
16
   1.7%
Asian
36
   5.8%
14
   4.5%
0 0 0
50
   5.4%
Native Hawaiian or Other Pacific Islander
4
   0.6%
1
   0.3%
0 0 0
5
   0.5%
Black or African American
59
   9.6%
29
   9.4%
0 0 0
88
   9.5%
White
483
  78.4%
249
  80.6%
0 0 0
732
  79.1%
More than one race
6
   1.0%
4
   1.3%
0 0 0
10
   1.1%
Unknown or Not Reported
17
   2.8%
7
   2.3%
0 0 0
24
   2.6%
[1]
Measure Description: Race summary for Season 1 participants
[2]
Measure Analysis Population Description: Race summary for Season 1 participants only
Race (NIH/OMB)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 180 participants 40 participants 42 participants 262 participants
American Indian or Alaska Native 0 0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian 0 0
10
   5.6%
3
   7.5%
2
   4.8%
15
   5.7%
Native Hawaiian or Other Pacific Islander 0 0
1
   0.6%
0
   0.0%
0
   0.0%
1
   0.4%
Black or African American 0 0
9
   5.0%
2
   5.0%
1
   2.4%
12
   4.6%
White 0 0
152
  84.4%
35
  87.5%
38
  90.5%
225
  85.9%
More than one race 0 0
3
   1.7%
0
   0.0%
1
   2.4%
4
   1.5%
Unknown or Not Reported 0 0
5
   2.8%
0
   0.0%
0
   0.0%
5
   1.9%
[1]
Measure Description: Race summary for Season 2 participants
[2]
Measure Analysis Population Description: Race summary for Season 2 participants only
Congenital heart disease   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 616 participants 309 participants 0 participants 0 participants 0 participants 925 participants
Yes
70
  11.4%
34
  11.0%
0 0 0
104
  11.2%
No
546
  88.6%
275
  89.0%
0 0 0
821
  88.8%
[1]
Measure Description: CHD summary for Season 1 participants
[2]
Measure Analysis Population Description: CHD summary for Season 1 participants only
Congenital heart disease   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 180 participants 40 participants 42 participants 262 participants
Yes 0 0
56
  31.1%
14
  35.0%
11
  26.2%
81
  30.9%
No 0 0
124
  68.9%
26
  65.0%
31
  73.8%
181
  69.1%
[1]
Measure Description: CHD summary for Season 2 participants
[2]
Measure Analysis Population Description: CHD summary for Season 2 participants only
Chronic lung disease   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 616 participants 309 participants 0 participants 0 participants 0 participants 925 participants
Yes
147
  23.9%
70
  22.7%
0 0 0
217
  23.5%
No
469
  76.1%
239
  77.3%
0 0 0
708
  76.5%
[1]
Measure Description: CLD summary for Season 1 participants
[2]
Measure Analysis Population Description: CLD summary for Season 1 participants only
Chronic lung disease   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 180 participants 40 participants 42 participants 262 participants
Yes 0 0
132
  73.3%
25
  62.5%
32
  76.2%
189
  72.1%
No 0 0
48
  26.7%
15
  37.5%
10
  23.8%
73
  27.9%
[1]
Measure Description: CLD summary for Season 2 participants
[2]
Measure Analysis Population Description: CLD summary for Season 2 participants only
1.Primary Outcome
Title Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD)
Hide Description Safety and tolerability of MEDI8897 will be assessed by the occurrence of all treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs) , adverse events of special interest (AESIs), and new onset chronic diseases (NOCDs)
Time Frame 360 days post first dose
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population
Arm/Group Title MEDI8897 Palivizumab MEDI8897/MEDI8897 Palivizumab/MEDI8897 Palivizumab/Palivizumab
Hide Arm/Group Description:
Subjects who received MEDI8897 in Season 1
Subjects who received Palivizumab in Season 1
CHD/CLD subjects who were randomized to MEDI8897 group in Season 1 and remained in MEDI8897 group in Season 2.
CHD/CLD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to MEDI8897 group in Season 2
CHD/CLD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to Palivizumab group in Season 2.
Overall Number of Participants Analyzed 614 304 180 40 42
Measure Type: Count of Participants
Unit of Measure: Participants
TEAE
444
  72.3%
215
  70.7%
130
  72.2%
31
  77.5%
29
  69.0%
TESAE
80
  13.0%
38
  12.5%
23
  12.8%
4
  10.0%
2
   4.8%
AESI
3
   0.5%
0
   0.0%
1
   0.6%
0
   0.0%
0
   0.0%
NOCD
3
   0.5%
0
   0.0%
1
   0.6%
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Serum Concentrations of MEDI8897 and Palivizumab
Hide Description Summary of individual MEDI8897 and palivizumab serum concentration data by treatment group along with descriptive statistics.
Time Frame Day 15, Day 31, Day 151 post first dose in Season 1 and Season 2
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population
Arm/Group Title MEDI8897 Palivizumab MEDI8897/MEDI8897 Palivizumab/MEDI8897 Palivizumab/Palivizumab
Hide Arm/Group Description:
Subjects who received MEDI8897 in Season 1
Subjects who received Palivizumab in Season 1
CHD/CLD subjects who were randomized to MEDI8897 group in Season 1 and remained in MEDI8897 group in Season 2
CLD/CHD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to MEDI8897 group in Season 2
CHD/CLD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to Palivizumab group in Season 2
Overall Number of Participants Analyzed 614 304 180 40 42
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug/mL
Serum concentrations of MEDI8897 and Palivizumab at Day 15 Number Analyzed 306 participants 167 participants 78 participants 20 participants 23 participants
104.75
(61.8%)
66.43
(55.7%)
149.38
(169.2%)
97.70
(302.0%)
59.62
(102.4%)
Serum concentrations of MEDI8897 and Palivizumab at Day 31 Number Analyzed 262 participants 119 participants 90 participants 18 participants 16 participants
85.35
(74.2%)
48.10
(50.0%)
89.71
(369.5%)
124.89
(256.1%)
57.77
(56.3%)
Serum concentrations of MEDI8897 and Palivizumab at Day 151 Number Analyzed 467 participants 238 participants 164 participants 38 participants 38 participants
25.38
(58.8%)
101.56
(65.6%)
39.86
(145.9%)
37.95
(118.6%)
67.66
(111.4%)
3.Secondary Outcome
Title Incidence of Anti-drug Antibody (ADA) to MEDI8897 and Palivizumab in Serum
Hide Description Incidence of ADA to MEDI8897 and palivizumab as assessed by the percentage of participants with any post-baseline ADA positive by treatment group.
Time Frame 360 days post first dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in as-treated population and with at least 1 post-baseline ADA sample
Arm/Group Title MEDI8897 Palivizumab MEDI8897/MEDI8897 Palivizumab/MEDI8897 Palivizumab/Palivizumab
Hide Arm/Group Description:
Subjects who received MEDI8897 in Season 1
Subjects who received Palivizumab in Season 1
CHD/CLD subjects who were randomized to MEDI8897 group in Season 1 and remained in MEDI8897 group in Season 2. Cumulative ADA data of Season 1 + Season 2 is reported.
CHD/CLD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to MEDI8897 group in Season 2
CHD/CLD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to Palivizumab group in Season 2. Cumulative ADA data of Season 1 + Season 2 is reported.
Overall Number of Participants Analyzed 587 289 180 40 42
Measure Type: Number
Unit of Measure: Percentage of participants
5.8 6.9 11.7 2.5 14.3
4.Secondary Outcome
Title Incidence of Medically Attended Lower Respiratory Track Infection (LRTI) and Hospitalization Due to Reverse Transcriptase Chain Reaction (RT-PCR) Confirmed Respiratory Syncytial Virus (RSV) Through 150 Days Post First Dose
Hide Description Incidence of medically attended LRTI (inpatient and outpatient) due to RT-PCR-confirmed RSV through 150 days after Dose 1 for season 1 and season 2. Incidence of LRTI hospitalizations due to RT-PCR-confirmed RSV through 150 days after Dose 1 for season 1 and season 2.
Time Frame 150 days post first dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title MEDI8897 Palivizumab MEDI8897/MEDI8897 Palivizumab/MEDI8897 Palivizumab/Palivizumab
Hide Arm/Group Description:
Subjects who were randomized to MEDI8897 group in Season 1
Subjects who were randomized to Palivizumab group in Season 1
CHD/CLD subjects who were randomized to MEDI8897 group in Season 1 and remained in MEDI8897 group in Season 2.
CHD/CLD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to MEDI8897 group in Season 2
CHD/CLD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to Palivizumab group in Season 2.
Overall Number of Participants Analyzed 616 309 180 40 42
Measure Type: Number
Unit of Measure: Percentage of participants
Incidence of medically attended RSV LRTI through 150 days post first dose, % 0.6 1.0 0 0 0
Incidence of medically attended RSV LRTI with hospitalization through 150 days post first dose, % 0.3 0.6 0 0 0
Time Frame Through 360 days post first dose of Season 1 for MEDI8897 and Palivizumab groups, through 360 days post first dose of Season 2 for MEDI8897/MEDI8897, MEDI8897/Palivizumab, and Palivizumab/Palivizumab groups.
Adverse Event Reporting Description

TEAEs of Season 1 are reported for MEDI8897 and Palivizumab groups. TEAEs of Season 2 are reported for MEDI8897/MEDI8897, MEDI8897/Palivizumab, and Palivizumab/Palivizumab groups.

Adverse events are reported based on as-treated population. Participants who were randomized and not dosed are not included in adverse event summaries.

 
Arm/Group Title MEDI8897 Palivizumab MEDI8897/MEDI8897 Palivizumab/MEDI8897 Palivizumab/Palivizumab
Hide Arm/Group Description Subjects who received MEDI8897 in Season 1. Subjects who received Palivizumab in Season 1. CHD/CLD subjects who received MEDI8897 in both Season 1 and Season 2. CLD/CHD subjects who received palivizumab in Season 1 and MEDI8897 in Season 2. CLD/CHD subjects who received Palivizumab in both Season 1 and Season 2.
All-Cause Mortality
MEDI8897 Palivizumab MEDI8897/MEDI8897 Palivizumab/MEDI8897 Palivizumab/Palivizumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/614 (0.81%)      1/304 (0.33%)      0/180 (0.00%)      0/40 (0.00%)      0/42 (0.00%)    
Hide Serious Adverse Events
MEDI8897 Palivizumab MEDI8897/MEDI8897 Palivizumab/MEDI8897 Palivizumab/Palivizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   80/614 (13.03%)      38/304 (12.50%)      23/180 (12.78%)      4/40 (10.00%)      2/42 (4.76%)    
Blood and lymphatic system disorders           
Anaemia  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Cardiac disorders           
Arrhythmia  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Atrioventricular block second degree  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Bradycardia  1  1/614 (0.16%)  1 2/304 (0.66%)  3 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Cardiac failure  1  1/614 (0.16%)  1 2/304 (0.66%)  2 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Cardiac failure congestive  1  1/614 (0.16%)  1 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Cardiogenic shock  1  1/614 (0.16%)  1 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Tricuspid valve incompetence  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Congenital, familial and genetic disorders           
Atrial septal defect  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Atrioventricular septal defect  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Craniosynostosis  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Fallot's tetralogy  1  1/614 (0.16%)  1 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Vascular malformation  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Ventricular septal defect  1  1/614 (0.16%)  1 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Eye disorders           
Retinopathy of prematurity  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Gastrointestinal disorders           
Diarrhoea  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Duodenal ulcer  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Enterocolitis  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Gastric fistula  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Incarcerated inguinal hernia  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Inguinal hernia  1  1/614 (0.16%)  1 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Intestinal obstruction  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Intussusception  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Vomiting  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Abdominal distension  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Anal fissure  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Ascites  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
General disorders           
Crying  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Fatigue  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Hyperthermia  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Oedema peripheral  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Pyrexia  1  2/614 (0.33%)  2 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Systemic inflammatory response syndrome  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Infections and infestations           
Adenovirus infection  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Bacterial infection  1  1/614 (0.16%)  1 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Bone abscess  1  0/614 (0.00%)  0 0/304 (0.00%)  0 0/180 (0.00%)  0 1/40 (2.50%)  1 0/42 (0.00%)  0
Bronchiolitis  1  11/614 (1.79%)  11 4/304 (1.32%)  4 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Bronchitis  1  5/614 (0.81%)  5 2/304 (0.66%)  2 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Bronchitis viral  1  0/614 (0.00%)  0 0/304 (0.00%)  0 3/180 (1.67%)  3 0/40 (0.00%)  0 0/42 (0.00%)  0
Covid-19  1  3/614 (0.49%)  3 1/304 (0.33%)  1 2/180 (1.11%)  2 0/40 (0.00%)  0 0/42 (0.00%)  0
Dacryocystitis  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Ear infection  1  0/614 (0.00%)  0 0/304 (0.00%)  0 0/180 (0.00%)  0 1/40 (2.50%)  1 0/42 (0.00%)  0
Gastric infection  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Gastroenteritis  1  6/614 (0.98%)  6 1/304 (0.33%)  1 3/180 (1.67%)  3 1/40 (2.50%)  1 1/42 (2.38%)  1
Gastroenteritis norovirus  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Gastroenteritis viral  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Gastrointestinal infection  1  0/614 (0.00%)  0 0/304 (0.00%)  0 0/180 (0.00%)  0 1/40 (2.50%)  1 0/42 (0.00%)  0
Gastrointestinal viral infection  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Hand-foot-and-mouth disease  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Lower respiratory tract infection  1  1/614 (0.16%)  1 2/304 (0.66%)  2 2/180 (1.11%)  2 1/40 (2.50%)  1 0/42 (0.00%)  0
Lower respiratory tract infection viral  1  2/614 (0.33%)  2 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 1/42 (2.38%)  1
Mastoiditis  1  0/614 (0.00%)  0 0/304 (0.00%)  0 0/180 (0.00%)  0 1/40 (2.50%)  1 0/42 (0.00%)  0
Meningitis aseptic  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Metapneumovirus bronchiolitis  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Nasopharyngitis  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Otitis media  1  0/614 (0.00%)  0 0/304 (0.00%)  0 0/180 (0.00%)  0 1/40 (2.50%)  1 0/42 (0.00%)  0
Otitis media acute  1  0/614 (0.00%)  0 0/304 (0.00%)  0 0/180 (0.00%)  0 1/40 (2.50%)  1 0/42 (0.00%)  0
Pharyngitis  1  0/614 (0.00%)  0 1/304 (0.33%)  1 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Pneumonia  1  5/614 (0.81%)  5 1/304 (0.33%)  1 2/180 (1.11%)  2 2/40 (5.00%)  2 0/42 (0.00%)  0
Pneumonia respiratory syncytial viral  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Pneumonia viral  1  1/614 (0.16%)  1 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Pyelonephritis  1  1/614 (0.16%)  2 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Pyelonephritis acute  1  1/614 (0.16%)  1 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Respiratory syncytial virus bronchiolitis  1  4/614 (0.65%)  4 2/304 (0.66%)  2 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Rotavirus infection  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Scrotal infection  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Sepsis  1  2/614 (0.33%)  2 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Septic shock  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Upper respiratory tract infection  1  1/614 (0.16%)  1 4/304 (1.32%)  5 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Urinary tract infection  1  2/614 (0.33%)  2 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Varicella  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Viral infection  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Viral upper respiratory tract infection  1  3/614 (0.49%)  4 1/304 (0.33%)  1 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Injury, poisoning and procedural complications           
Endotracheal intubation complication  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Gastrostomy tube site complication  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Head injury  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Lower limb fracture  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Skull fracture  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Vaccination complication  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Investigations           
Catheterisation cardiac  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Oxygen saturation decreased  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Metabolism and nutrition disorders           
Dehydration  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Failure to thrive  1  2/614 (0.33%)  2 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Feeding disorder  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Feeding intolerance  1  2/614 (0.33%)  2 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Hypophagia  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Underweight  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Haemangioma  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Nervous system disorders           
Dyskinesia  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Embolic stroke  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Epilepsy  1  0/614 (0.00%)  0 1/304 (0.33%)  2 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Haemorrhage intracranial  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Hypotonia  1  1/614 (0.16%)  2 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Loss of consciousness  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Nystagmus  1  0/614 (0.00%)  0 0/304 (0.00%)  0 0/180 (0.00%)  0 1/40 (2.50%)  1 0/42 (0.00%)  0
Syncope  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Renal and urinary disorders           
Calculus urinary  1  1/614 (0.16%)  1 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Hydronephrosis  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Reproductive system and breast disorders           
Intermenstrual bleeding  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Anaemic hypoxia  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Apnoea  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Bronchopulmonary dysplasia  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Chylothorax  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Diaphragm muscle weakness  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Hypoxia  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Infantile apnoea  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Laryngeal stenosis  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Pleural effusion  1  0/614 (0.00%)  0 0/304 (0.00%)  0 2/180 (1.11%)  2 0/40 (0.00%)  0 0/42 (0.00%)  0
Pulmonary artery stenosis  1  1/614 (0.16%)  2 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Pulmonary hypertensive crisis  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Pulmonary oedema  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Respiratory distress  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Skin and subcutaneous tissue disorders           
Angioedema  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Social circumstances           
Social problem  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Social stay hospitalisation  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Vascular disorders           
Cyanosis  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
1
Term from vocabulary, MedDRA 25.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MEDI8897 Palivizumab MEDI8897/MEDI8897 Palivizumab/MEDI8897 Palivizumab/Palivizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   435/614 (70.85%)      211/304 (69.41%)      129/180 (71.67%)      31/40 (77.50%)      29/42 (69.05%)    
Blood and lymphatic system disorders           
Pancytopenia  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Thrombocytopenia  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Thrombocytosis  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Anaemia  1  12/614 (1.95%)  12 5/304 (1.64%)  5 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Anaemia neonatal  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Heparin-induced thrombocytopenia  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Iron deficiency anaemia  1  5/614 (0.81%)  5 3/304 (0.99%)  3 3/180 (1.67%)  3 0/40 (0.00%)  0 0/42 (0.00%)  0
Lymphadenitis  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Lymphadenopathy  1  2/614 (0.33%)  2 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Monocytosis  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Neutropenia  1  0/614 (0.00%)  0 2/304 (0.66%)  2 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Cardiac disorders           
Atrial fibrillation  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Atrioventricular block  1  0/614 (0.00%)  0 1/304 (0.33%)  1 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Atrioventricular block complete  1  1/614 (0.16%)  1 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Atrioventricular block second degree  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Bundle branch block right  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Cardiac failure  1  0/614 (0.00%)  0 3/304 (0.99%)  3 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Cardiac failure chronic  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Cardiac septal hypertrophy  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Low cardiac output syndrome  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Mitral valve incompetence  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Pericardial effusion  1  2/614 (0.33%)  3 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Right atrial dilatation  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Sinus bradycardia  1  0/614 (0.00%)  0 2/304 (0.66%)  2 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Supraventricular tachycardia  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Tachycardia  1  1/614 (0.16%)  1 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Tricuspid valve incompetence  1  1/614 (0.16%)  2 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Congenital, familial and genetic disorders           
Anomalous pulmonary venous connection  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Atrial septal defect  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Brachycephaly  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Cerebellar hypoplasia  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Cerebral palsy  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Cleft palate  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Congenital choroid plexus cyst  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Congenital nystagmus  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Congenital oral malformation  1  0/614 (0.00%)  0 2/304 (0.66%)  2 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Cryptorchism  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Cystic fibrosis  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Dacryostenosis congenital  1  0/614 (0.00%)  0 2/304 (0.66%)  2 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Dysmorphism  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Eyelid ptosis congenital  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Hydrocele  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Laryngomalacia  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Left ventricle outflow tract obstruction  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Phimosis  1  1/614 (0.16%)  1 2/304 (0.66%)  2 1/180 (0.56%)  1 0/40 (0.00%)  0 1/42 (2.38%)  1
Plagiocephaly  1  1/614 (0.16%)  1 3/304 (0.99%)  3 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Vascular malformation  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Ear and labyrinth disorders           
Cerumen impaction  1  3/614 (0.49%)  3 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Deafness  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Ear pain  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Eustachian tube dysfunction  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
External ear inflammation  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Hypoacusis  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Neurosensory hypoacusis  1  1/614 (0.16%)  1 1/304 (0.33%)  1 0/180 (0.00%)  0 1/40 (2.50%)  1 0/42 (0.00%)  0
Noninfective myringitis  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Otorrhoea  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Tympanic membrane perforation  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 1/42 (2.38%)  1
Endocrine disorders           
Hypothyroidism  1  0/614 (0.00%)  0 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 1/42 (2.38%)  1
Eye disorders           
Anisocoria  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Anisometropia  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Astigmatism  1  1/614 (0.16%)  1 2/304 (0.66%)  2 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Blepharitis  1  0/614 (0.00%)  0 1/304 (0.33%)  1 1/180 (0.56%)  2 0/40 (0.00%)  0 0/42 (0.00%)  0
Blepharospasm  1  0/614 (0.00%)  0 0/304 (0.00%)  0 0/180 (0.00%)  0 1/40 (2.50%)  1 0/42 (0.00%)  0
Cataract  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Chalazion  1  1/614 (0.16%)  1 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Choroidal effusion  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Conjunctivitis allergic  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Eye allergy  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Eye discharge  1  1/614 (0.16%)  2 4/304 (1.32%)  5 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Eye inflammation  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Eyelid function disorder  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Eyelid ptosis  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Heterophoria  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Hypermetropia  1  3/614 (0.49%)  3 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Inflammation of lacrimal passage  1  1/614 (0.16%)  1 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Myopia  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Periorbital swelling  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Retinopathy  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Retinopathy of prematurity  1  2/614 (0.33%)  2 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Strabismus  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Gastrointestinal disorders           
Diarrhoea  1  29/614 (4.72%)  33 11/304 (3.62%)  12 10/180 (5.56%)  12 2/40 (5.00%)  3 7/42 (16.67%)  7
Diarrhoea haemorrhagic  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Dysbiosis  1  2/614 (0.33%)  3 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Dyschezia  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Dyspepsia  1  3/614 (0.49%)  3 0/304 (0.00%)  0 2/180 (1.11%)  2 1/40 (2.50%)  1 0/42 (0.00%)  0
Dysphagia  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Enteritis  1  3/614 (0.49%)  4 2/304 (0.66%)  3 3/180 (1.67%)  5 0/40 (0.00%)  0 1/42 (2.38%)  1
Enterocolitis  1  2/614 (0.33%)  2 0/304 (0.00%)  0 0/180 (0.00%)  0 1/40 (2.50%)  1 0/42 (0.00%)  0
Faecaloma  1  2/614 (0.33%)  3 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Faeces discoloured  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Faeces pale  1  1/614 (0.16%)  1 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Faeces soft  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Flatulence  1  1/614 (0.16%)  1 5/304 (1.64%)  5 0/180 (0.00%)  0 0/40 (0.00%)  0 1/42 (2.38%)  1
Functional gastrointestinal disorder  1  1/614 (0.16%)  1 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Gastric fistula  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Gastritis  1  1/614 (0.16%)  1 2/304 (0.66%)  2 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Gastrointestinal pain  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Gastrooesophageal reflux disease  1  13/614 (2.12%)  13 9/304 (2.96%)  9 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Haematochezia  1  1/614 (0.16%)  2 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Ileus  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Infantile colic  1  9/614 (1.47%)  9 6/304 (1.97%)  6 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Infantile spitting up  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Inguinal hernia  1  3/614 (0.49%)  3 2/304 (0.66%)  2 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Oesophagitis  1  0/614 (0.00%)  0 0/304 (0.00%)  0 0/180 (0.00%)  0 1/40 (2.50%)  1 0/42 (0.00%)  0
Small intestinal obstruction  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Stomatitis  1  2/614 (0.33%)  2 0/304 (0.00%)  0 0/180 (0.00%)  0 1/40 (2.50%)  1 0/42 (0.00%)  0
Teething  1  31/614 (5.05%)  35 16/304 (5.26%)  19 7/180 (3.89%)  7 0/40 (0.00%)  0 2/42 (4.76%)  2
Tongue erythema  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Toothache  1  0/614 (0.00%)  0 2/304 (0.66%)  3 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Umbilical hernia  1  2/614 (0.33%)  2 2/304 (0.66%)  2 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Vomiting  1  15/614 (2.44%)  17 11/304 (3.62%)  14 6/180 (3.33%)  7 4/40 (10.00%)  5 3/42 (7.14%)  8
Abdominal distension  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Abdominal pain  1  1/614 (0.16%)  1 1/304 (0.33%)  1 1/180 (0.56%)  1 0/40 (0.00%)  0 1/42 (2.38%)  1
Abdominal pain upper  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Anal erythema  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Anal fissure  1  1/614 (0.16%)  1 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Anal fissure haemorrhage  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Ankyloglossia acquired  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Aphthous ulcer  1  4/614 (0.65%)  4 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Constipation  1  37/614 (6.03%)  39 20/304 (6.58%)  28 5/180 (2.78%)  5 2/40 (5.00%)  2 2/42 (4.76%)  2
General disorders           
Calcinosis  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Catheter site haematoma  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Developmental delay  1  1/614 (0.16%)  1 1/304 (0.33%)  1 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Discomfort  1  0/614 (0.00%)  0 1/304 (0.33%)  2 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Drug tolerance  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Drug withdrawal syndrome  1  2/614 (0.33%)  2 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Fatigue  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 1/40 (2.50%)  1 0/42 (0.00%)  0
Fever neonatal  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Hyperthermia  1  1/614 (0.16%)  1 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Impaired healing  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Incarcerated hernia  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Injection site erythema  1  2/614 (0.33%)  2 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Injection site induration  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Injection site reaction  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Medical device site irritation  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Medical device site rash  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Oedema  1  0/614 (0.00%)  0 1/304 (0.33%)  1 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Pain  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Peripheral swelling  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Pyrexia  1  81/614 (13.19%)  109 43/304 (14.14%)  57 23/180 (12.78%)  37 9/40 (22.50%)  12 6/42 (14.29%)  14
Secretion discharge  1  1/614 (0.16%)  1 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Swelling  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Systemic inflammatory response syndrome  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Vaccination site erythema  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Vaccination site reaction  1  1/614 (0.16%)  1 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Vaccination site swelling  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Vaccination site urticaria  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Hepatobiliary disorders           
Hepatitis  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Hypertransaminasaemia  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Jaundice  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Sphincter of oddi dysfunction  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Immune system disorders           
Drug hypersensitivity  1  1/614 (0.16%)  1 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Food allergy  1  6/614 (0.98%)  6 3/304 (0.99%)  3 1/180 (0.56%)  1 0/40 (0.00%)  0 1/42 (2.38%)  1
Hypersensitivity  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Milk allergy  1  6/614 (0.98%)  6 3/304 (0.99%)  3 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Nutritional supplement allergy  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Seasonal allergy  1  2/614 (0.33%)  2 0/304 (0.00%)  0 2/180 (1.11%)  2 0/40 (0.00%)  0 0/42 (0.00%)  0
Infections and infestations           
Acarodermatitis  1  4/614 (0.65%)  4 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Acute sinusitis  1  0/614 (0.00%)  0 0/304 (0.00%)  0 0/180 (0.00%)  0 1/40 (2.50%)  1 0/42 (0.00%)  0
Adenoiditis  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 1/42 (2.38%)  1
Adenovirus infection  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 1/42 (2.38%)  1
Anal fungal infection  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Bacterial blepharitis  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Body tinea  1  1/614 (0.16%)  1 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Bronchiolitis  1  22/614 (3.58%)  27 9/304 (2.96%)  12 9/180 (5.00%)  11 0/40 (0.00%)  0 2/42 (4.76%)  2
Bronchitis  1  20/614 (3.26%)  28 10/304 (3.29%)  16 7/180 (3.89%)  7 4/40 (10.00%)  7 1/42 (2.38%)  1
Covid-19  1  8/614 (1.30%)  8 2/304 (0.66%)  2 14/180 (7.78%)  14 3/40 (7.50%)  3 5/42 (11.90%)  5
Candida infection  1  2/614 (0.33%)  2 3/304 (0.99%)  5 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Candida nappy rash  1  1/614 (0.16%)  1 1/304 (0.33%)  1 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Catheter site infection  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Cellulitis  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Clostridium difficile infection  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Conjunctivitis  1  25/614 (4.07%)  31 10/304 (3.29%)  12 11/180 (6.11%)  11 1/40 (2.50%)  1 3/42 (7.14%)  3
Conjunctivitis bacterial  1  0/614 (0.00%)  0 0/304 (0.00%)  0 2/180 (1.11%)  2 0/40 (0.00%)  0 0/42 (0.00%)  0
Conjunctivitis viral  1  1/614 (0.16%)  2 0/304 (0.00%)  0 1/180 (0.56%)  2 0/40 (0.00%)  0 0/42 (0.00%)  0
Coronavirus infection  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Croup infectious  1  1/614 (0.16%)  1 1/304 (0.33%)  1 1/180 (0.56%)  1 1/40 (2.50%)  1 0/42 (0.00%)  0
Dacryocystitis  1  2/614 (0.33%)  2 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Dermatitis infected  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Device related sepsis  1  1/614 (0.16%)  1 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Ear infection  1  5/614 (0.81%)  8 5/304 (1.64%)  6 2/180 (1.11%)  3 1/40 (2.50%)  1 2/42 (4.76%)  2
Enterobiasis  1  0/614 (0.00%)  0 0/304 (0.00%)  0 0/180 (0.00%)  0 1/40 (2.50%)  2 0/42 (0.00%)  0
Enterovirus infection  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 1/42 (2.38%)  1
Exanthema subitum  1  9/614 (1.47%)  9 4/304 (1.32%)  4 1/180 (0.56%)  1 1/40 (2.50%)  1 0/42 (0.00%)  0
Eye infection  1  0/614 (0.00%)  0 1/304 (0.33%)  2 1/180 (0.56%)  1 1/40 (2.50%)  1 0/42 (0.00%)  0
Fungal skin infection  1  7/614 (1.14%)  7 3/304 (0.99%)  3 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Gastroenteritis  1  19/614 (3.09%)  21 15/304 (4.93%)  15 11/180 (6.11%)  19 1/40 (2.50%)  1 2/42 (4.76%)  3
Gastroenteritis adenovirus  1  1/614 (0.16%)  1 1/304 (0.33%)  1 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Gastroenteritis norovirus  1  2/614 (0.33%)  2 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Gastroenteritis rotavirus  1  0/614 (0.00%)  0 0/304 (0.00%)  0 0/180 (0.00%)  0 1/40 (2.50%)  1 0/42 (0.00%)  0
Gastroenteritis sapovirus  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Gastroenteritis viral  1  3/614 (0.49%)  3 2/304 (0.66%)  2 4/180 (2.22%)  4 2/40 (5.00%)  2 0/42 (0.00%)  0
Gastroenteritis yersinia  1  2/614 (0.33%)  2 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Gastrointestinal bacterial overgrowth  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Gastrointestinal infection  1  2/614 (0.33%)  2 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Gastrointestinal viral infection  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Genital infection fungal  1  0/614 (0.00%)  0 1/304 (0.33%)  1 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Giardiasis  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Gingivitis  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Hand-foot-and-mouth disease  1  15/614 (2.44%)  15 6/304 (1.97%)  6 9/180 (5.00%)  9 0/40 (0.00%)  0 2/42 (4.76%)  2
Herpes virus infection  1  2/614 (0.33%)  2 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Hordeolum  1  2/614 (0.33%)  3 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Human herpesvirus 6 infection  1  1/614 (0.16%)  1 1/304 (0.33%)  1 3/180 (1.67%)  3 0/40 (0.00%)  0 0/42 (0.00%)  0
Impetigo  1  1/614 (0.16%)  1 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Infection  1  0/614 (0.00%)  0 1/304 (0.33%)  1 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Infectious mononucleosis  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Laryngitis  1  11/614 (1.79%)  12 7/304 (2.30%)  12 3/180 (1.67%)  4 2/40 (5.00%)  2 1/42 (2.38%)  1
Laryngopharyngitis  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Lice infestation  1  0/614 (0.00%)  0 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 1/42 (2.38%)  1
Lower respiratory tract infection  1  18/614 (2.93%)  21 10/304 (3.29%)  13 1/180 (0.56%)  3 3/40 (7.50%)  4 0/42 (0.00%)  0
Lower respiratory tract infection viral  1  3/614 (0.49%)  3 0/304 (0.00%)  0 0/180 (0.00%)  0 1/40 (2.50%)  1 0/42 (0.00%)  0
Molluscum contagiosum  1  0/614 (0.00%)  0 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 1/42 (2.38%)  1
Nasopharyngitis  1  57/614 (9.28%)  84 39/304 (12.83%)  50 26/180 (14.44%)  55 7/40 (17.50%)  16 9/42 (21.43%)  15
Oral candidiasis  1  10/614 (1.63%)  10 6/304 (1.97%)  7 3/180 (1.67%)  3 0/40 (0.00%)  0 0/42 (0.00%)  0
Oropharyngeal candidiasis  1  1/614 (0.16%)  1 1/304 (0.33%)  2 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Otitis externa  1  0/614 (0.00%)  0 3/304 (0.99%)  3 1/180 (0.56%)  1 0/40 (0.00%)  0 1/42 (2.38%)  1
Otitis media  1  27/614 (4.40%)  37 11/304 (3.62%)  14 12/180 (6.67%)  16 3/40 (7.50%)  3 2/42 (4.76%)  3
Otitis media acute  1  16/614 (2.61%)  20 14/304 (4.61%)  18 11/180 (6.11%)  19 5/40 (12.50%)  6 2/42 (4.76%)  4
Otitis media chronic  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 1/42 (2.38%)  1
Otitis media viral  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Otosalpingitis  1  0/614 (0.00%)  0 1/304 (0.33%)  1 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Parasitic gastroenteritis  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Pharyngitis  1  23/614 (3.75%)  29 8/304 (2.63%)  8 7/180 (3.89%)  9 2/40 (5.00%)  2 0/42 (0.00%)  0
Pharyngitis streptococcal  1  1/614 (0.16%)  1 0/304 (0.00%)  0 1/180 (0.56%)  2 0/40 (0.00%)  0 0/42 (0.00%)  0
Pharyngotonsillitis  1  1/614 (0.16%)  1 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Pneumonia  1  4/614 (0.65%)  4 3/304 (0.99%)  3 2/180 (1.11%)  2 0/40 (0.00%)  0 1/42 (2.38%)  1
Pneumonia aspiration  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  2 0/40 (0.00%)  0 0/42 (0.00%)  0
Pneumonia bacterial  1  0/614 (0.00%)  0 0/304 (0.00%)  0 1/180 (0.56%)  1 0/40 (0.00%)  0 0/42 (0.00%)  0
Pneumonia haemophilus  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Pneumonia parainfluenzae viral  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Post procedural infection  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Pustule  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Pyelonephritis  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Pyoderma  1  1/614 (0.16%)  1 0/304 (0.00%)  0 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Rash pustular  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Respiratory syncytial virus bronchiolitis  1  2/614 (0.33%)  2 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0
Respiratory syncytial virus infection  1  0/614 (0.00%)  0 1/304 (0.33%)  1 0/180 (0.00%)  0 0/40 (0.00%)  0 0/42 (0.00%)  0