Trial Outcomes & Findings for Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children (NCT NCT00129766)
NCT ID: NCT00129766
Last Updated: 2013-08-28
Results Overview
RSV hospitalization was defined as 1) a respiratory hospitalization with a positive RSV test (primary), 2) a new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial), or 3) death demonstrated to have been caused by RSV (by autopsy or clinical history and virologic evidence).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
6635 participants
Primary outcome timeframe
Days 0 - 150
Results posted on
2013-08-28
Participant Flow
A total of 6,635 children were randomized in a 1:1 ratio at 347 centers in 24 countries within the Northern and Southern hemispheres between 01/Nov/2004 and 09/Dec/2005; each child participated in the study for a single RSV season.
Randomization was blocked by study site and stratified according to presence/absence of CLD of prematurity requiring medical intervention/management.
Participant milestones
| Measure |
Palivizumab
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
Overall Study
STARTED
|
3306
|
3329
|
|
Overall Study
COMPLETED
|
3246
|
3270
|
|
Overall Study
NOT COMPLETED
|
60
|
59
|
Reasons for withdrawal
| Measure |
Palivizumab
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
Overall Study
Death
|
3
|
8
|
|
Overall Study
Withdrawal of consent
|
31
|
30
|
|
Overall Study
Lost to Follow-up
|
26
|
21
|
Baseline Characteristics
Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children
Baseline characteristics by cohort
| Measure |
Palivizumab
n=3306 Participants
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
n=3329 Participants
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Total
n=6635 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
3.98 months
STANDARD_DEVIATION 3.78 • n=93 Participants
|
3.99 months
STANDARD_DEVIATION 3.75 • n=4 Participants
|
3.99 months
STANDARD_DEVIATION 3.76 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1495 Participants
n=93 Participants
|
1513 Participants
n=4 Participants
|
3008 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1811 Participants
n=93 Participants
|
1816 Participants
n=4 Participants
|
3627 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
1130 participants
n=93 Participants
|
1167 participants
n=4 Participants
|
2297 participants
n=27 Participants
|
|
Region of Enrollment
Greece
|
32 participants
n=93 Participants
|
34 participants
n=4 Participants
|
66 participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
191 participants
n=93 Participants
|
181 participants
n=4 Participants
|
372 participants
n=27 Participants
|
|
Region of Enrollment
Turkey
|
36 participants
n=93 Participants
|
42 participants
n=4 Participants
|
78 participants
n=27 Participants
|
|
Region of Enrollment
Austria
|
35 participants
n=93 Participants
|
34 participants
n=4 Participants
|
69 participants
n=27 Participants
|
|
Region of Enrollment
Russian Federation
|
42 participants
n=93 Participants
|
45 participants
n=4 Participants
|
87 participants
n=27 Participants
|
|
Region of Enrollment
Israel
|
301 participants
n=93 Participants
|
305 participants
n=4 Participants
|
606 participants
n=27 Participants
|
|
Region of Enrollment
Chile
|
93 participants
n=93 Participants
|
87 participants
n=4 Participants
|
180 participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
89 participants
n=93 Participants
|
90 participants
n=4 Participants
|
179 participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
93 participants
n=93 Participants
|
96 participants
n=4 Participants
|
189 participants
n=27 Participants
|
|
Region of Enrollment
France
|
107 participants
n=93 Participants
|
111 participants
n=4 Participants
|
218 participants
n=27 Participants
|
|
Region of Enrollment
Hungary
|
198 participants
n=93 Participants
|
192 participants
n=4 Participants
|
390 participants
n=27 Participants
|
|
Region of Enrollment
Czech Republic
|
171 participants
n=93 Participants
|
177 participants
n=4 Participants
|
348 participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
134 participants
n=93 Participants
|
132 participants
n=4 Participants
|
266 participants
n=27 Participants
|
|
Region of Enrollment
Argentina
|
38 participants
n=93 Participants
|
34 participants
n=4 Participants
|
72 participants
n=27 Participants
|
|
Region of Enrollment
Poland
|
106 participants
n=93 Participants
|
105 participants
n=4 Participants
|
211 participants
n=27 Participants
|
|
Region of Enrollment
Brazil
|
69 participants
n=93 Participants
|
66 participants
n=4 Participants
|
135 participants
n=27 Participants
|
|
Region of Enrollment
Australia
|
85 participants
n=93 Participants
|
81 participants
n=4 Participants
|
166 participants
n=27 Participants
|
|
Region of Enrollment
Denmark
|
30 participants
n=93 Participants
|
27 participants
n=4 Participants
|
57 participants
n=27 Participants
|
|
Region of Enrollment
Bulgaria
|
95 participants
n=93 Participants
|
101 participants
n=4 Participants
|
196 participants
n=27 Participants
|
|
Region of Enrollment
Iceland
|
20 participants
n=93 Participants
|
19 participants
n=4 Participants
|
39 participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
131 participants
n=93 Participants
|
122 participants
n=4 Participants
|
253 participants
n=27 Participants
|
|
Region of Enrollment
New Zealand
|
26 participants
n=93 Participants
|
26 participants
n=4 Participants
|
52 participants
n=27 Participants
|
|
Region of Enrollment
Sweden
|
54 participants
n=93 Participants
|
55 participants
n=4 Participants
|
109 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Days 0 - 150Population: The Intent-to-Treat (ITT) Population included all patients randomized into the study.
RSV hospitalization was defined as 1) a respiratory hospitalization with a positive RSV test (primary), 2) a new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial), or 3) death demonstrated to have been caused by RSV (by autopsy or clinical history and virologic evidence).
Outcome measures
| Measure |
Palivizumab
n=3306 Participants
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
n=3329 Participants
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
Incidence of RSV Hospitalization (Includes Deaths by RSV)
|
62 Participants
|
46 Participants
|
PRIMARY outcome
Timeframe: Days 0 - 150Population: The Safety Population included all patients who received any study drug and had any safety follow-up.
Number of participants reporting one or more AEs
Outcome measures
| Measure |
Palivizumab
n=3298 Participants
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
n=3315 Participants
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
Number of Participants Reporting Any Adverse Events (AEs)
|
2837 participants
|
2839 participants
|
PRIMARY outcome
Timeframe: Days 0 - 150Population: The Safety Population included all patients who received any study drug and had any safety follow-up.
Number of participants reporting one or more AEs considered related to study drug by the investigator
Outcome measures
| Measure |
Palivizumab
n=3298 Participants
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
n=3315 Participants
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
Number of Participants Reporting Any Related AEs
|
258 participants
|
298 participants
|
PRIMARY outcome
Timeframe: Days 0 - 150Population: The Safety Population included all patients who received any study drug and had any safety follow-up.
Number of participants reporting one or more SAEs
Outcome measures
| Measure |
Palivizumab
n=3298 Participants
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
n=3315 Participants
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
Number of Participants Reporting Any Serious Adverse Events (SAEs)
|
506 participants
|
485 participants
|
PRIMARY outcome
Timeframe: Days 0 - 150Population: The Safety Population included all patients who received any study drug and had any safety follow-up.
Number of participants reporting one or more SAEs considered related to study drug by the investigator
Outcome measures
| Measure |
Palivizumab
n=3298 Participants
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
n=3315 Participants
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
Number of Participants Reporting Any Related SAEs
|
8 participants
|
9 participants
|
PRIMARY outcome
Timeframe: Days 0 - 150Population: The Safety Population included all patients who received any study drug and had any safety follow-up.
Adverse events events were graded by severity; Level 1, 2, 3, or 4
Outcome measures
| Measure |
Palivizumab
n=3298 Participants
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
n=3315 Participants
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
Number of Participants Reporting AEs by Highest Severity Grade
Level 1
|
1478 participants
|
1538 participants
|
|
Number of Participants Reporting AEs by Highest Severity Grade
Level 2
|
1006 participants
|
976 participants
|
|
Number of Participants Reporting AEs by Highest Severity Grade
Level 3
|
292 participants
|
271 participants
|
|
Number of Participants Reporting AEs by Highest Severity Grade
Level 4
|
61 participants
|
54 participants
|
PRIMARY outcome
Timeframe: Days 0 - 150Population: The Safety Population included all patients who received any study drug and had any safety follow-up.
Outcome measures
| Measure |
Palivizumab
n=3298 Participants
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
n=3315 Participants
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to AEs
|
10 participants
|
13 participants
|
PRIMARY outcome
Timeframe: Days 0 - 150Population: The Safety Population included all patients who received any study drug and had any safety follow-up.
Outcome measures
| Measure |
Palivizumab
n=3298 Participants
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
n=3315 Participants
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
Number of Participants Who Died
|
4 participants
|
8 participants
|
PRIMARY outcome
Timeframe: Days 0 - 150Population: The Safety Population included all patients who received any study drug and had any safety follow-up.
Vital signs that were in a higher toxicity grade than observed at baseline were to be recorded as AEs
Outcome measures
| Measure |
Palivizumab
n=3298 Participants
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
n=3315 Participants
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
Number of Participants Reporting Changes in Vital Signs From Baseline
Fever neonatal
|
0 participants
|
2 participants
|
|
Number of Participants Reporting Changes in Vital Signs From Baseline
Hyperpyrexia
|
0 participants
|
1 participants
|
|
Number of Participants Reporting Changes in Vital Signs From Baseline
Hyperthermia
|
3 participants
|
3 participants
|
|
Number of Participants Reporting Changes in Vital Signs From Baseline
Hypothermia
|
2 participants
|
2 participants
|
|
Number of Participants Reporting Changes in Vital Signs From Baseline
Pyrexia
|
559 participants
|
544 participants
|
|
Number of Participants Reporting Changes in Vital Signs From Baseline
Hypertension
|
4 participants
|
4 participants
|
|
Number of Participants Reporting Changes in Vital Signs From Baseline
Hypotension
|
2 participants
|
2 participants
|
|
Number of Participants Reporting Changes in Vital Signs From Baseline
Arrhythmia
|
1 participants
|
0 participants
|
|
Number of Participants Reporting Changes in Vital Signs From Baseline
Bradycardia
|
10 participants
|
4 participants
|
|
Number of Participants Reporting Changes in Vital Signs From Baseline
Tachycardia
|
4 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Day 0 - 150Population: The Intent-to-Treat (ITT) Population included all patients randomized into the study.
LRI was defined as an event of bronchiolitis or pneumonia or the occurance of a lower tract infectious illness as determined by the PI based on medical history, signs, and symptoms.
Outcome measures
| Measure |
Palivizumab
n=3306 Participants
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
n=3329 Participants
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
The Incidence of Outpatient Medically-attended Lower Respiratory Illness (LRI)
|
696 Participant
|
648 Participant
|
SECONDARY outcome
Timeframe: Days 0 - 150Population: Subjects were from a pre-specified subsets of sites participating in the nasal secretion sample collection for this endpoint.
The RSV-specific LRI was defined as an outpatient medically-attended LRI associated with a positive RSV test and was not inclusive of events that required hospitalization.
Outcome measures
| Measure |
Palivizumab
n=1183 Participants
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
n=1227 Participants
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
The Incidence of RSV-specific Medically-attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups
|
46 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Days 0 - 150Population: The Intent-to-Treat (ITT) Population included all patients randomized into the study.
Otitis media (OM) was to be recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute tympanic membrane (TM) perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not to be recorded as a new OM event.
Outcome measures
| Measure |
Palivizumab
n=3306 Participants
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
n=3329 Participants
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
The Incidence of Medically-attended Otitis Media (OM) Infections
Overall incidence
|
461 Participants
|
484 Participants
|
|
The Incidence of Medically-attended Otitis Media (OM) Infections
0 infections
|
2845 Participants
|
2845 Participants
|
|
The Incidence of Medically-attended Otitis Media (OM) Infections
1 infection
|
329 Participants
|
360 Participants
|
|
The Incidence of Medically-attended Otitis Media (OM) Infections
2 infections
|
100 Participants
|
91 Participants
|
|
The Incidence of Medically-attended Otitis Media (OM) Infections
3 or more infections
|
32 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Days 0 - 150Population: The Intent-to-Treat (ITT) Population included all patients randomized into the study.
The average number of presciptions per event per subject was summarized for each treatment group.
Outcome measures
| Measure |
Palivizumab
n=3306 Participants
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
n=3329 Participants
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
The Frequency of Prescribed Antibiotics for Medically-attended LRI
|
0.32 Number of prescriptions
Standard Deviation 0.02
|
0.30 Number of prescriptions
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: Days 0 - 150Population: The Intent-to-Treat (ITT) Population included all patients randomized into the study.
The average number of presciptions per event per subject was summarized for each treatment group.
Outcome measures
| Measure |
Palivizumab
n=3306 Participants
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
n=3329 Participants
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
The Frequency of Prescribed Antibiotics for Medically-attended OM Infections
|
1.08 number of prescriptions
Standard Deviation 0.003
|
1.10 number of prescriptions
Standard Deviation 0.003
|
SECONDARY outcome
Timeframe: Day 0 - 120Population: N varied at different timepoints: at pre-dose 1 N=3193; at 30 days post-dose 1 N=998; at 30 days post-dose 2 N=1049; at 30 days post-dose 3 N=1049; at 30 days post-dose 4, N=3013; at any time post baseline, N=3217
Detection of anti-motavizumab antibodies was defined as a titer with a dilution value equal to or greater than 1:10.
Outcome measures
| Measure |
Palivizumab
n=3217 Participants
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
The Number of Participants With Anti-motavizumab Antibodies
Pre-dose 1
|
7 participants
|
—
|
|
The Number of Participants With Anti-motavizumab Antibodies
30 Days Post-Dose 1
|
1 participants
|
—
|
|
The Number of Participants With Anti-motavizumab Antibodies
30 Days Post-Dose 2
|
1 participants
|
—
|
|
The Number of Participants With Anti-motavizumab Antibodies
30 Days Post-Dose 3
|
7 participants
|
—
|
|
The Number of Participants With Anti-motavizumab Antibodies
30 Days Post-Dose 4
|
18 participants
|
—
|
|
The Number of Participants With Anti-motavizumab Antibodies
At any time post baseline
|
22 participants
|
—
|
SECONDARY outcome
Timeframe: Day 0Population: The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug.
Mean serum concentrations of motavizumab at Day 0
Outcome measures
| Measure |
Palivizumab
n=3147 Participants
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
The Serum Concentrations of Motavizumab at Day 0
|
0.01193 ug/mL
Standard Deviation 0.2072
|
—
|
SECONDARY outcome
Timeframe: 30 days post Dose 1Population: The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 1 measurements
Mean serum concentrations of motavizumab at 30 days post Dose 1
Outcome measures
| Measure |
Palivizumab
n=974 Participants
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 1
|
45.95 ug/mL
Standard Deviation 15.17
|
—
|
SECONDARY outcome
Timeframe: 30 days post Dose 2Population: The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 2 measurements
Mean serum concentrations of motavizumab at 30 days post Dose 2
Outcome measures
| Measure |
Palivizumab
n=915 Participants
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 2
|
64.59 ug/mL
Standard Deviation 25.60
|
—
|
SECONDARY outcome
Timeframe: 30 days post Dose 3Population: The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 3 measurements
Mean serum concentrations of motavizumab at 30 days post Dose 3
Outcome measures
| Measure |
Palivizumab
n=918 Participants
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 3
|
80.24 ug/mL
Standard Deviation 31.22
|
—
|
SECONDARY outcome
Timeframe: 30 days post Dose 4Population: The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 4 measurements
Mean serum concentrations of motavizumab at 30 days post Dose 4
Outcome measures
| Measure |
Palivizumab
n=2669 Participants
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 4
|
88.52 ug/mL
Standard Deviation 35.43
|
—
|
Adverse Events
Palivizumab
Serious events: 506 serious events
Other events: 2777 other events
Deaths: 0 deaths
Motavizumab
Serious events: 485 serious events
Other events: 2784 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Palivizumab
n=3298 participants at risk
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
n=3315 participants at risk
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.12%
4/3298 • Number of events 4 • Day 0 - Day 150
|
0.15%
5/3315 • Number of events 5 • Day 0 - Day 150
|
|
Blood and lymphatic system disorders
ANAEMIA NEONATAL
|
0.09%
3/3298 • Number of events 3 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Blood and lymphatic system disorders
CYCLIC NEUTROPENIA
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Blood and lymphatic system disorders
HAEMOLYTIC ANAEMIA
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Blood and lymphatic system disorders
HAEMOLYTIC URAEMIC SYNDROME
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Cardiac disorders
ATRIAL THROMBOSIS
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Cardiac disorders
BRADYCARDIA
|
0.12%
4/3298 • Number of events 4 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Cardiac disorders
CARDIAC ARREST
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Cardiac disorders
CARDIAC FAILURE HIGH OUTPUT
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Cardiac disorders
CYANOSIS
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
ACRODERMATITIS ENTEROPATHICA
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
ANAL ATRESIA
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
ANKYLOGLOSSIA CONGENITAL
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
BRANCHIAL CLEFT CYST
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
CEREBRAL PALSY
|
0.03%
1/3298 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
CLEFT LIP
|
0.00%
0/3298 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
CLEFT LIP AND PALATE
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
CLEFT PALATE
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
DACRYOSTENOSIS CONGENITAL
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
DERMOID CYST
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
HAMARTOMA
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
HIP DYSPLASIA
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
LIMB REDUCTION DEFECT
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
PHIMOSIS
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
PILONIDAL CYST CONGENITAL
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
PYLORIC STENOSIS
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
RESPIRATORY TRACT MALFORMATION
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
SYNDACTYLY
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
TALIPES
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 7 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
TRACHEO-OESOPHAGEAL FISTULA
|
0.03%
1/3298 • Number of events 3 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
VENTRICULAR SEPTAL DEFECT
|
0.03%
1/3298 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Ear and labyrinth disorders
DEAFNESS
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Eye disorders
PAPILLOEDEMA
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Eye disorders
RETINOPATHY OF PREMATURITY
|
0.21%
7/3298 • Number of events 7 • Day 0 - Day 150
|
0.15%
5/3315 • Number of events 5 • Day 0 - Day 150
|
|
Eye disorders
RETINOPATHY PROLIFERATIVE
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.09%
3/3298 • Number of events 3 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Gastrointestinal disorders
ABDOMINAL STRANGULATED HERNIA
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Gastrointestinal disorders
ANAL FISTULA
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Gastrointestinal disorders
COLONIC STENOSIS
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/3298 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.15%
5/3298 • Number of events 6 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Gastrointestinal disorders
ENTERITIS
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Gastrointestinal disorders
ENTEROCUTANEOUS FISTULA
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Gastrointestinal disorders
FAECES DISCOLOURED
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Gastrointestinal disorders
FLATULENCE
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDER
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 2 • Day 0 - Day 150
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.64%
21/3298 • Number of events 22 • Day 0 - Day 150
|
0.54%
18/3315 • Number of events 20 • Day 0 - Day 150
|
|
Gastrointestinal disorders
HIATUS HERNIA
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Gastrointestinal disorders
ILEUS
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
1.7%
57/3298 • Number of events 58 • Day 0 - Day 150
|
1.7%
56/3315 • Number of events 58 • Day 0 - Day 150
|
|
Gastrointestinal disorders
INGUINAL HERNIA, OBSTRUCTIVE
|
0.09%
3/3298 • Number of events 4 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Gastrointestinal disorders
INTUSSUSCEPTION
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Gastrointestinal disorders
NECROTISING COLITIS
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Gastrointestinal disorders
OESOPHAGEAL MASS
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Gastrointestinal disorders
REFLUX OESOPHAGITIS
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Gastrointestinal disorders
REGURGITATION
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Gastrointestinal disorders
VOMITING
|
0.09%
3/3298 • Number of events 3 • Day 0 - Day 150
|
0.15%
5/3315 • Number of events 5 • Day 0 - Day 150
|
|
General disorders
FEVER NEONATAL
|
0.00%
0/3298 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
General disorders
HERNIA
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
General disorders
HERNIA OBSTRUCTIVE
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
General disorders
HYPOTHERMIA
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
General disorders
MALAISE
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
General disorders
OEDEMA PERIPHERAL
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
General disorders
PYREXIA
|
0.27%
9/3298 • Number of events 9 • Day 0 - Day 150
|
0.30%
10/3315 • Number of events 11 • Day 0 - Day 150
|
|
General disorders
SUDDEN DEATH
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
General disorders
SUDDEN INFANT DEATH SYNDROME
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.09%
3/3315 • Number of events 3 • Day 0 - Day 150
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Hepatobiliary disorders
CHOLESTASIS
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Hepatobiliary disorders
HEPATIC CYST
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Immune system disorders
IMMUNISATION REACTION
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
ABSCESS LIMB
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
ABSCESS NECK
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
ADENOVIRAL UPPER RESPIRATORY INFECTION
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
BACTERAEMIA
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
BACTERIAL ABSCESS CENTRAL NERVOUS SYSTEM
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
BACTERIAL PYELONEPHRITIS
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
BACTERIAL TRACHEITIS
|
0.03%
1/3298 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
BRONCHIOLITIS
|
2.4%
78/3298 • Number of events 88 • Day 0 - Day 150
|
2.1%
71/3315 • Number of events 87 • Day 0 - Day 150
|
|
Infections and infestations
BRONCHITIS
|
1.1%
36/3298 • Number of events 46 • Day 0 - Day 150
|
1.1%
35/3315 • Number of events 39 • Day 0 - Day 150
|
|
Infections and infestations
BRONCHITIS VIRAL
|
0.09%
3/3298 • Number of events 3 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.24%
8/3298 • Number of events 8 • Day 0 - Day 150
|
0.36%
12/3315 • Number of events 13 • Day 0 - Day 150
|
|
Infections and infestations
CATHETER SEPSIS
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
CELLULITIS
|
0.09%
3/3298 • Number of events 3 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
CENTRAL LINE INFECTION
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
CLOSTRIDIAL INFECTION
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
CROUP INFECTIOUS
|
0.21%
7/3298 • Number of events 8 • Day 0 - Day 150
|
0.18%
6/3315 • Number of events 6 • Day 0 - Day 150
|
|
Infections and infestations
CYTOMEGALOVIRUS INFECTION
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
DACRYOCYSTITIS
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
DYSENTERY
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
ENTEROBACTER BACTERAEMIA
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
ENTEROCOLITIS VIRAL
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
EXANTHEMA SUBITUM
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
EXTERNAL EAR CELLULITIS
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
GASTROENTERITIS
|
0.94%
31/3298 • Number of events 31 • Day 0 - Day 150
|
0.81%
27/3315 • Number of events 28 • Day 0 - Day 150
|
|
Infections and infestations
GASTROENTERITIS ADENOVIRUS
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
GASTROENTERITIS ESCHERICHIA COLI
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
GASTROENTERITIS ROTAVIRUS
|
0.64%
21/3298 • Number of events 21 • Day 0 - Day 150
|
0.39%
13/3315 • Number of events 15 • Day 0 - Day 150
|
|
Infections and infestations
GASTROENTERITIS SALMONELLA
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.18%
6/3298 • Number of events 6 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Infections and infestations
HERPES ZOSTER
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
IMPETIGO
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
INFECTION
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
INFLUENZA
|
0.09%
3/3298 • Number of events 3 • Day 0 - Day 150
|
0.12%
4/3315 • Number of events 4 • Day 0 - Day 150
|
|
Infections and infestations
LARYNGITIS
|
0.15%
5/3298 • Number of events 7 • Day 0 - Day 150
|
0.15%
5/3315 • Number of events 5 • Day 0 - Day 150
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.09%
3/3298 • Number of events 3 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.24%
8/3298 • Number of events 8 • Day 0 - Day 150
|
0.18%
6/3315 • Number of events 6 • Day 0 - Day 150
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION VIRAL
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
LUNG ABSCESS
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
LYMPHADENITIS BACTERIAL
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
MENINGITIS VIRAL
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.09%
3/3298 • Number of events 3 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
OSTEOMYELITIS
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
OTITIS MEDIA
|
0.12%
4/3298 • Number of events 4 • Day 0 - Day 150
|
0.09%
3/3315 • Number of events 3 • Day 0 - Day 150
|
|
Infections and infestations
OTITIS MEDIA BACTERIAL
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
PARAINFLUENZAE VIRUS INFECTION
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
PERTUSSIS
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
PHARYNGITIS
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
PHARYNGOTONSILLITIS
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
PNEUMONIA
|
0.94%
31/3298 • Number of events 31 • Day 0 - Day 150
|
0.81%
27/3315 • Number of events 28 • Day 0 - Day 150
|
|
Infections and infestations
PNEUMONIA ADENOVIRAL
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
PNEUMONIA BORDETELLA
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
PNEUMONIA INFLUENZAL
|
0.09%
3/3298 • Number of events 4 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
PNEUMONIA PARAINFLUENZAE VIRAL
|
0.09%
3/3298 • Number of events 4 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL
|
0.30%
10/3298 • Number of events 10 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.09%
3/3315 • Number of events 3 • Day 0 - Day 150
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
PYELONEPHRITIS
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS
|
1.2%
40/3298 • Number of events 43 • Day 0 - Day 150
|
0.75%
25/3315 • Number of events 25 • Day 0 - Day 150
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS INFECTION
|
0.09%
3/3298 • Number of events 3 • Day 0 - Day 150
|
0.09%
3/3315 • Number of events 3 • Day 0 - Day 150
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
RHINITIS
|
0.09%
3/3298 • Number of events 3 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
ROTAVIRUS INFECTION
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
SEPSIS
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
TRACHEITIS
|
0.06%
2/3298 • Number of events 3 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
TRACHEOBRONCHITIS
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.67%
22/3298 • Number of events 23 • Day 0 - Day 150
|
0.42%
14/3315 • Number of events 14 • Day 0 - Day 150
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.21%
7/3298 • Number of events 7 • Day 0 - Day 150
|
0.30%
10/3315 • Number of events 10 • Day 0 - Day 150
|
|
Infections and infestations
URINARY TRACT INFECTION BACTERIAL
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
URINARY TRACT INFECTION ENTEROCOCCAL
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
URINARY TRACT INFECTION PSEUDOMONAL
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
UROSEPSIS
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
VARICELLA
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Infections and infestations
VIRAL INFECTION
|
0.21%
7/3298 • Number of events 7 • Day 0 - Day 150
|
0.12%
4/3315 • Number of events 4 • Day 0 - Day 150
|
|
Infections and infestations
VIRAL RHINITIS
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.18%
6/3315 • Number of events 7 • Day 0 - Day 150
|
|
Infections and infestations
WOUND INFECTION
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 2 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
CHILD MALTREATMENT SYNDROME
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
DEVICE MALFUNCTION
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
FACE INJURY
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
FEEDING TUBE COMPLICATION
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
FOREIGN BODY TRAUMA
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
HAIR-THREAD TOURNIQUET SYNDROME
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.09%
3/3298 • Number of events 3 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
INJURY
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
MEDICAL DEVICE COMPLICATION
|
0.00%
0/3298 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL DISCHARGE
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
SHUNT MALFUNCTION
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
SKULL FRACTURE
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
TRAUMATIC BRAIN INJURY
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
VENTRICULOPERITONEAL SHUNT MALFUNCTION
|
0.12%
4/3298 • Number of events 4 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 3 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
VIIITH NERVE INJURY
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Investigations
BIOPSY RECTUM
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Investigations
CYSTOGRAM
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Investigations
FALSE POSITIVE LABORATORY RESULT
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Investigations
INVESTIGATION
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Investigations
MEDICAL OBSERVATION
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Investigations
NEUROLOGICAL EXAMINATION
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Investigations
OESOPHAGEAL PH
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Investigations
OXYGEN SATURATION DECREASED
|
0.06%
2/3298 • Number of events 5 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Investigations
PHYSICAL EXAMINATION
|
0.09%
3/3298 • Number of events 3 • Day 0 - Day 150
|
0.09%
3/3315 • Number of events 3 • Day 0 - Day 150
|
|
Investigations
WEIGHT DECREASED
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
ANOREXIA
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
COW'S MILK INTOLERANCE
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.09%
3/3315 • Number of events 3 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
0.18%
6/3298 • Number of events 6 • Day 0 - Day 150
|
0.15%
5/3315 • Number of events 8 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
FEEDING DISORDER OF INFANCY OR EARLY CHILDHOOD
|
0.21%
7/3298 • Number of events 7 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 3 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
FLUID INTAKE REDUCED
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
FLUID OVERLOAD
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
HYPERNATRAEMIA
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 2 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
LACTOSE INTOLERANCE
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 3 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
WEIGHT GAIN POOR
|
0.09%
3/3298 • Number of events 3 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
ZINC DEFICIENCY
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Musculoskeletal and connective tissue disorders
CRANIOSYNOSTOSIS
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Musculoskeletal and connective tissue disorders
MUSCLE CONTRACTURE
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Musculoskeletal and connective tissue disorders
OSTEOPENIA
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HAEMANGIOMA
|
0.12%
4/3298 • Number of events 4 • Day 0 - Day 150
|
0.12%
4/3315 • Number of events 7 • Day 0 - Day 150
|
|
Nervous system disorders
ALTERED STATE OF CONSCIOUSNESS
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Nervous system disorders
CEREBRAL VENTRICLE DILATATION
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Nervous system disorders
CONVULSION
|
0.12%
4/3298 • Number of events 5 • Day 0 - Day 150
|
0.09%
3/3315 • Number of events 5 • Day 0 - Day 150
|
|
Nervous system disorders
CONVULSION NEONATAL
|
0.03%
1/3298 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Nervous system disorders
ENCEPHALITIS
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Nervous system disorders
EPILEPSY
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Nervous system disorders
FEBRILE CONVULSION
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 2 • Day 0 - Day 150
|
|
Nervous system disorders
HYDROCEPHALUS
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.15%
5/3315 • Number of events 5 • Day 0 - Day 150
|
|
Nervous system disorders
HYPERTONIA
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Nervous system disorders
HYPOXIC ENCEPHALOPATHY
|
0.09%
3/3298 • Number of events 4 • Day 0 - Day 150
|
0.12%
4/3315 • Number of events 6 • Day 0 - Day 150
|
|
Nervous system disorders
INTRACRANIAL PRESSURE INCREASED
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/3298 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 3 • Day 0 - Day 150
|
|
Nervous system disorders
MYOCLONUS
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Nervous system disorders
SOMNOLENCE
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Nervous system disorders
SYNCOPE VASOVAGAL
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Nervous system disorders
VOCAL CORD PARESIS
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Psychiatric disorders
BREATH HOLDING
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Psychiatric disorders
RESTLESSNESS
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Renal and urinary disorders
URETERIC STENOSIS
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Reproductive system and breast disorders
BALANITIS
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Reproductive system and breast disorders
SCROTAL OEDEMA
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
APNOEA
|
0.52%
17/3298 • Number of events 23 • Day 0 - Day 150
|
0.42%
14/3315 • Number of events 16 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
APPARENT LIFE THREATENING EVENT
|
0.00%
0/3298 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
ASPIRATION
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.15%
5/3298 • Number of events 5 • Day 0 - Day 150
|
0.21%
7/3315 • Number of events 7 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.00%
0/3298 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 3 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL HYPERREACTIVITY
|
0.21%
7/3298 • Number of events 8 • Day 0 - Day 150
|
0.21%
7/3315 • Number of events 7 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOPNEUMOPATHY
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOPULMONARY DYSPLASIA
|
0.30%
10/3298 • Number of events 10 • Day 0 - Day 150
|
0.27%
9/3315 • Number of events 11 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.00%
0/3298 • Day 0 - Day 150
|
0.09%
3/3315 • Number of events 5 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
CHOKING
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
FOREIGN BODY ASPIRATION
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
HYPOVENTILATION
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL OEDEMA
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL STENOSIS
|
0.09%
3/3298 • Number of events 3 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGOSPASM
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
LUNG CONSOLIDATION
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
OBSTRUCTIVE AIRWAYS DISORDER
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGEAL INFLAMMATION
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.09%
3/3315 • Number of events 3 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/3298 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY CONGESTION
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HAEMORRHAGE
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
0.12%
4/3298 • Number of events 7 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSIVE CRISIS
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISORDER
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 4 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
STATUS ASTHMATICUS
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
STRIDOR
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 2 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
TACHYPNOEA
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
TONSILLAR HYPERTROPHY
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
VOCAL CORD DISORDER
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.09%
3/3298 • Number of events 3 • Day 0 - Day 150
|
0.15%
5/3315 • Number of events 7 • Day 0 - Day 150
|
|
Skin and subcutaneous tissue disorders
ANGIOEDEMA
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/3298 • Day 0 - Day 150
|
0.06%
2/3315 • Number of events 2 • Day 0 - Day 150
|
|
Social circumstances
SOCIAL STAY HOSPITALISATION
|
0.06%
2/3298 • Number of events 2 • Day 0 - Day 150
|
0.12%
4/3315 • Number of events 4 • Day 0 - Day 150
|
|
Social circumstances
VICTIM OF CHILD ABUSE
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Surgical and medical procedures
CENTRAL VENOUS CATHETERISATION
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Surgical and medical procedures
COLOSTOMY CLOSURE
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Surgical and medical procedures
EAR TUBE INSERTION
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Surgical and medical procedures
GASTROSTOMY CLOSURE
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Surgical and medical procedures
GASTROSTOMY TUBE INSERTION
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Surgical and medical procedures
ILEOSTOMY CLOSURE
|
0.09%
3/3298 • Number of events 3 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Surgical and medical procedures
NUTRITIONAL SUPPORT
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Surgical and medical procedures
VENTRICULO-PERITONEAL SHUNT
|
0.00%
0/3298 • Day 0 - Day 150
|
0.03%
1/3315 • Number of events 1 • Day 0 - Day 150
|
|
Vascular disorders
HAEMORRHAGE
|
0.03%
1/3298 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
|
Vascular disorders
HYPERTENSION
|
0.06%
2/3298 • Number of events 4 • Day 0 - Day 150
|
0.00%
0/3315 • Day 0 - Day 150
|
Other adverse events
| Measure |
Palivizumab
n=3298 participants at risk
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
Motavizumab
n=3315 participants at risk
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
2.2%
73/3298 • Number of events 75 • Day 0 - Day 150
|
2.0%
66/3315 • Number of events 67 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
DACRYOSTENOSIS CONGENITAL
|
1.0%
33/3298 • Number of events 34 • Day 0 - Day 150
|
1.1%
35/3315 • Number of events 37 • Day 0 - Day 150
|
|
Eye disorders
CONJUNCTIVITIS
|
7.6%
251/3298 • Number of events 285 • Day 0 - Day 150
|
7.4%
246/3315 • Number of events 271 • Day 0 - Day 150
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.1%
70/3298 • Number of events 73 • Day 0 - Day 150
|
1.6%
54/3315 • Number of events 55 • Day 0 - Day 150
|
|
Gastrointestinal disorders
CONSTIPATION
|
6.9%
227/3298 • Number of events 262 • Day 0 - Day 150
|
7.1%
234/3315 • Number of events 265 • Day 0 - Day 150
|
|
Gastrointestinal disorders
DIARRHOEA
|
8.3%
274/3298 • Number of events 306 • Day 0 - Day 150
|
7.7%
254/3315 • Number of events 295 • Day 0 - Day 150
|
|
Gastrointestinal disorders
FLATULENCE
|
3.6%
119/3298 • Number of events 135 • Day 0 - Day 150
|
3.8%
126/3315 • Number of events 170 • Day 0 - Day 150
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
5.8%
190/3298 • Number of events 198 • Day 0 - Day 150
|
5.7%
190/3315 • Number of events 197 • Day 0 - Day 150
|
|
Gastrointestinal disorders
TEETHING
|
8.6%
282/3298 • Number of events 408 • Day 0 - Day 150
|
9.0%
299/3315 • Number of events 417 • Day 0 - Day 150
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
1.9%
63/3298 • Number of events 63 • Day 0 - Day 150
|
2.3%
77/3315 • Number of events 77 • Day 0 - Day 150
|
|
Gastrointestinal disorders
VOMITING
|
5.0%
164/3298 • Number of events 179 • Day 0 - Day 150
|
4.8%
158/3315 • Number of events 174 • Day 0 - Day 150
|
|
General disorders
INJECTION SITE ERYTHEMA
|
0.85%
28/3298 • Number of events 38 • Day 0 - Day 150
|
1.2%
41/3315 • Number of events 52 • Day 0 - Day 150
|
|
General disorders
INJECTION SITE PAIN
|
1.5%
49/3298 • Number of events 94 • Day 0 - Day 150
|
1.4%
45/3315 • Number of events 81 • Day 0 - Day 150
|
|
General disorders
IRRITABILITY
|
5.0%
164/3298 • Number of events 243 • Day 0 - Day 150
|
5.8%
193/3315 • Number of events 299 • Day 0 - Day 150
|
|
General disorders
PYREXIA
|
16.9%
556/3298 • Number of events 729 • Day 0 - Day 150
|
16.4%
543/3315 • Number of events 718 • Day 0 - Day 150
|
|
Infections and infestations
BRONCHIOLITIS
|
6.7%
222/3298 • Number of events 263 • Day 0 - Day 150
|
5.8%
193/3315 • Number of events 226 • Day 0 - Day 150
|
|
Infections and infestations
BRONCHITIS
|
7.9%
260/3298 • Number of events 356 • Day 0 - Day 150
|
6.9%
230/3315 • Number of events 328 • Day 0 - Day 150
|
|
Infections and infestations
CANDIDIASIS
|
2.4%
79/3298 • Number of events 93 • Day 0 - Day 150
|
1.7%
58/3315 • Number of events 65 • Day 0 - Day 150
|
|
Immune system disorders
IMMUNISATION REACTION
|
2.9%
97/3298 • Number of events 122 • Day 0 - Day 150
|
3.1%
102/3315 • Number of events 138 • Day 0 - Day 150
|
|
Infections and infestations
GASTROENTERITIS
|
6.3%
207/3298 • Number of events 223 • Day 0 - Day 150
|
6.0%
199/3315 • Number of events 212 • Day 0 - Day 150
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.97%
32/3298 • Number of events 36 • Day 0 - Day 150
|
1.2%
40/3315 • Number of events 40 • Day 0 - Day 150
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
4.0%
133/3298 • Number of events 165 • Day 0 - Day 150
|
3.9%
130/3315 • Number of events 159 • Day 0 - Day 150
|
|
Infections and infestations
NASOPHARYNGITIS
|
7.9%
262/3298 • Number of events 333 • Day 0 - Day 150
|
7.2%
240/3315 • Number of events 325 • Day 0 - Day 150
|
|
Infections and infestations
ORAL CANDIDIASIS
|
3.2%
107/3298 • Number of events 120 • Day 0 - Day 150
|
3.0%
101/3315 • Number of events 113 • Day 0 - Day 150
|
|
Infections and infestations
OTITIS MEDIA
|
12.7%
418/3298 • Number of events 565 • Day 0 - Day 150
|
13.0%
432/3315 • Number of events 575 • Day 0 - Day 150
|
|
Infections and infestations
OTITIS MEDIA ACUTE
|
1.6%
54/3298 • Number of events 79 • Day 0 - Day 150
|
2.0%
65/3315 • Number of events 83 • Day 0 - Day 150
|
|
Infections and infestations
PHARYNGITIS
|
2.8%
91/3298 • Number of events 101 • Day 0 - Day 150
|
2.1%
70/3315 • Number of events 81 • Day 0 - Day 150
|
|
Infections and infestations
PNEUMONIA
|
1.1%
35/3298 • Number of events 39 • Day 0 - Day 150
|
0.45%
15/3315 • Number of events 15 • Day 0 - Day 150
|
|
Infections and infestations
RHINITIS
|
13.5%
444/3298 • Number of events 593 • Day 0 - Day 150
|
13.3%
440/3315 • Number of events 600 • Day 0 - Day 150
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
29.7%
981/3298 • Number of events 1482 • Day 0 - Day 150
|
28.8%
956/3315 • Number of events 1420 • Day 0 - Day 150
|
|
Infections and infestations
VIRAL INFECTION
|
3.0%
98/3298 • Number of events 112 • Day 0 - Day 150
|
2.6%
86/3315 • Number of events 103 • Day 0 - Day 150
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
1.8%
60/3298 • Number of events 64 • Day 0 - Day 150
|
1.7%
56/3315 • Number of events 64 • Day 0 - Day 150
|
|
Investigations
BLOOD UREA INCREASED
|
0.76%
25/3298 • Number of events 25 • Day 0 - Day 150
|
1.1%
35/3315 • Number of events 35 • Day 0 - Day 150
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HAEMANGIOMA
|
1.2%
38/3298 • Number of events 41 • Day 0 - Day 150
|
0.87%
29/3315 • Number of events 34 • Day 0 - Day 150
|
|
Psychiatric disorders
AGITATION
|
1.4%
47/3298 • Number of events 61 • Day 0 - Day 150
|
1.1%
35/3315 • Number of events 51 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
1.1%
37/3298 • Number of events 45 • Day 0 - Day 150
|
1.00%
33/3315 • Number of events 37 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL HYPERREACTIVITY
|
1.6%
54/3298 • Number of events 62 • Day 0 - Day 150
|
1.3%
44/3315 • Number of events 48 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
6.5%
216/3298 • Number of events 262 • Day 0 - Day 150
|
6.6%
220/3315 • Number of events 260 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
8.0%
265/3298 • Number of events 326 • Day 0 - Day 150
|
8.1%
269/3315 • Number of events 318 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISORDER
|
8.3%
275/3298 • Number of events 374 • Day 0 - Day 150
|
8.9%
295/3315 • Number of events 380 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
2.8%
92/3298 • Number of events 112 • Day 0 - Day 150
|
3.0%
99/3315 • Number of events 124 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
2.1%
70/3298 • Number of events 85 • Day 0 - Day 150
|
1.5%
51/3315 • Number of events 61 • Day 0 - Day 150
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ATOPIC
|
1.6%
53/3298 • Number of events 55 • Day 0 - Day 150
|
1.3%
44/3315 • Number of events 48 • Day 0 - Day 150
|
|
Skin and subcutaneous tissue disorders
DERMATITIS DIAPER
|
5.8%
192/3298 • Number of events 233 • Day 0 - Day 150
|
5.3%
177/3315 • Number of events 199 • Day 0 - Day 150
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.76%
25/3298 • Number of events 26 • Day 0 - Day 150
|
1.1%
35/3315 • Number of events 37 • Day 0 - Day 150
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
2.9%
95/3298 • Number of events 100 • Day 0 - Day 150
|
4.0%
132/3315 • Number of events 140 • Day 0 - Day 150
|
|
Skin and subcutaneous tissue disorders
RASH
|
3.1%
103/3298 • Number of events 110 • Day 0 - Day 150
|
3.9%
130/3315 • Number of events 147 • Day 0 - Day 150
|
|
Skin and subcutaneous tissue disorders
SEBORRHOEIC DERMATITIS
|
1.6%
52/3298 • Number of events 53 • Day 0 - Day 150
|
1.7%
56/3315 • Number of events 57 • Day 0 - Day 150
|
Additional Information
M. Pamela Griffin, Sr. Director, Clinical Development
MedImmune
Phone: 301-398-0000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER