Trial Outcomes & Findings for 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 (NCT NCT03959488)
NCT ID: NCT03959488
Last Updated: 2023-09-21
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
925 participants
Primary outcome timeframe
360 days post first dose
Results posted on
2023-09-21
Participant Flow
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.
Participant milestones
| Measure |
MEDI8897
Subjects who were randomized to MEDI8897 group in Season 1
|
Palivizumab
Subjects who were randomized to Palivizumab group in Season 1
|
MEDI8897/MEDI8897
CHD/CLD subjects who were randomized to MEDI8897 group in Season 1 and remained in MEDI8897 group in Season 2.
|
Palivizumab/MEDI8897
CHD/CLD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to MEDI8897 group in Season 2
|
Palivizumab/Palivizumab
CLD/CHD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to Palivizumab group in Season 2
|
|---|---|---|---|---|---|
|
Season 1
STARTED
|
616
|
309
|
0
|
0
|
0
|
|
Season 1
COMPLETED
|
543
|
263
|
0
|
0
|
0
|
|
Season 1
NOT COMPLETED
|
73
|
46
|
0
|
0
|
0
|
|
Season 2
STARTED
|
0
|
0
|
180
|
40
|
42
|
|
Season 2
COMPLETED
|
0
|
0
|
174
|
39
|
40
|
|
Season 2
NOT COMPLETED
|
0
|
0
|
6
|
1
|
2
|
Reasons for withdrawal
| Measure |
MEDI8897
Subjects who were randomized to MEDI8897 group in Season 1
|
Palivizumab
Subjects who were randomized to Palivizumab group in Season 1
|
MEDI8897/MEDI8897
CHD/CLD subjects who were randomized to MEDI8897 group in Season 1 and remained in MEDI8897 group in Season 2.
|
Palivizumab/MEDI8897
CHD/CLD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to MEDI8897 group in Season 2
|
Palivizumab/Palivizumab
CLD/CHD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to Palivizumab group in Season 2
|
|---|---|---|---|---|---|
|
Season 1
Other
|
6
|
7
|
0
|
0
|
0
|
|
Season 1
Withdrawal by parent/guardian
|
43
|
28
|
0
|
0
|
0
|
|
Season 1
Due to COVID-19 pandemic
|
2
|
3
|
0
|
0
|
0
|
|
Season 1
Lost to Follow-up
|
17
|
7
|
0
|
0
|
0
|
|
Season 1
Death
|
5
|
1
|
0
|
0
|
0
|
|
Season 2
Other
|
0
|
0
|
2
|
0
|
0
|
|
Season 2
Withdrawal by parent/guardian
|
0
|
0
|
3
|
1
|
1
|
|
Season 2
Lost to Follow-up
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
This summary is for Season 1 participants only
Baseline characteristics by cohort
| Measure |
MEDI8897
n=616 Participants
Subjects who were randomized to MEDI8897 group in Season 1
|
Palivizumab
n=309 Participants
Subjects who were randomized to Palivizumab group in Season 1
|
MEDI8897/MEDI8897
n=180 Participants
CHD/CLD subjects who were randomized to MEDI8897 group in Season 1 and remained in MEDI8897 group in Season 2.
|
Palivizumab/MEDI8897
n=40 Participants
CHD/CLD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to MEDI8897 group in Season 2
|
Palivizumab/Palivizumab
n=42 Participants
CLD/CHD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to Palivizumab group in Season 2
|
Total
n=1187 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
Age at randomization (months)
|
3.947 Months
STANDARD_DEVIATION 2.5513 • n=616 Participants • This summary is for Season 1 participants only
|
3.840 Months
STANDARD_DEVIATION 2.4608 • n=309 Participants • This summary is for Season 1 participants only
|
—
|
—
|
—
|
3.911 Months
STANDARD_DEVIATION 2.5206 • n=925 Participants • This summary is for Season 1 participants only
|
|
Age, Continuous
Age at first dose of Season 2 (Months)
|
—
|
—
|
16.772 Months
STANDARD_DEVIATION 2.7141 • n=180 Participants • This summary is for Season 2 participants only
|
16.598 Months
STANDARD_DEVIATION 2.4335 • n=40 Participants • This summary is for Season 2 participants only
|
16.132 Months
STANDARD_DEVIATION 2.1040 • n=42 Participants • This summary is for Season 2 participants only
|
16.643 Months
STANDARD_DEVIATION 2.5857 • n=262 Participants • This summary is for Season 2 participants only
|
|
Sex: Female, Male
Female
|
0 Participants
Sex summary for Season 2 participants only
|
0 Participants
Sex summary for Season 2 participants only
|
81 Participants
n=180 Participants • Sex summary for Season 2 participants only
|
15 Participants
n=40 Participants • Sex summary for Season 2 participants only
|
15 Participants
n=42 Participants • Sex summary for Season 2 participants only
|
111 Participants
n=262 Participants • Sex summary for Season 2 participants only
|
|
Sex: Female, Male
Male
|
0 Participants
Sex summary for Season 2 participants only
|
0 Participants
Sex summary for Season 2 participants only
|
99 Participants
n=180 Participants • Sex summary for Season 2 participants only
|
25 Participants
n=40 Participants • Sex summary for Season 2 participants only
|
27 Participants
n=42 Participants • Sex summary for Season 2 participants only
|
151 Participants
n=262 Participants • Sex summary for Season 2 participants only
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
Race summary for Season 2 participants only
|
0 Participants
Race summary for Season 2 participants only
|
0 Participants
n=180 Participants • Race summary for Season 2 participants only
|
0 Participants
n=40 Participants • Race summary for Season 2 participants only
|
0 Participants
n=42 Participants • Race summary for Season 2 participants only
|
0 Participants
n=262 Participants • Race summary for Season 2 participants only
|
|
Race (NIH/OMB)
Asian
|
0 Participants
Race summary for Season 2 participants only
|
0 Participants
Race summary for Season 2 participants only
|
10 Participants
n=180 Participants • Race summary for Season 2 participants only
|
3 Participants
n=40 Participants • Race summary for Season 2 participants only
|
2 Participants
n=42 Participants • Race summary for Season 2 participants only
|
15 Participants
n=262 Participants • Race summary for Season 2 participants only
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
Race summary for Season 2 participants only
|
0 Participants
Race summary for Season 2 participants only
|
1 Participants
n=180 Participants • Race summary for Season 2 participants only
|
0 Participants
n=40 Participants • Race summary for Season 2 participants only
|
0 Participants
n=42 Participants • Race summary for Season 2 participants only
|
1 Participants
n=262 Participants • Race summary for Season 2 participants only
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
Race summary for Season 2 participants only
|
0 Participants
Race summary for Season 2 participants only
|
9 Participants
n=180 Participants • Race summary for Season 2 participants only
|
2 Participants
n=40 Participants • Race summary for Season 2 participants only
|
1 Participants
n=42 Participants • Race summary for Season 2 participants only
|
12 Participants
n=262 Participants • Race summary for Season 2 participants only
|
|
Race (NIH/OMB)
White
|
0 Participants
Race summary for Season 2 participants only
|
0 Participants
Race summary for Season 2 participants only
|
152 Participants
n=180 Participants • Race summary for Season 2 participants only
|
35 Participants
n=40 Participants • Race summary for Season 2 participants only
|
38 Participants
n=42 Participants • Race summary for Season 2 participants only
|
225 Participants
n=262 Participants • Race summary for Season 2 participants only
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
Race summary for Season 2 participants only
|
0 Participants
Race summary for Season 2 participants only
|
3 Participants
n=180 Participants • Race summary for Season 2 participants only
|
0 Participants
n=40 Participants • Race summary for Season 2 participants only
|
1 Participants
n=42 Participants • Race summary for Season 2 participants only
|
4 Participants
n=262 Participants • Race summary for Season 2 participants only
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
Race summary for Season 2 participants only
|
0 Participants
Race summary for Season 2 participants only
|
5 Participants
n=180 Participants • Race summary for Season 2 participants only
|
0 Participants
n=40 Participants • Race summary for Season 2 participants only
|
0 Participants
n=42 Participants • Race summary for Season 2 participants only
|
5 Participants
n=262 Participants • Race summary for Season 2 participants only
|
|
Congenital heart disease
Yes
|
0 Participants
CHD summary for Season 2 participants only
|
0 Participants
CHD summary for Season 2 participants only
|
56 Participants
n=180 Participants • CHD summary for Season 2 participants only
|
14 Participants
n=40 Participants • CHD summary for Season 2 participants only
|
11 Participants
n=42 Participants • CHD summary for Season 2 participants only
|
81 Participants
n=262 Participants • CHD summary for Season 2 participants only
|
|
Congenital heart disease
No
|
0 Participants
CHD summary for Season 2 participants only
|
0 Participants
CHD summary for Season 2 participants only
|
124 Participants
n=180 Participants • CHD summary for Season 2 participants only
|
26 Participants
n=40 Participants • CHD summary for Season 2 participants only
|
31 Participants
n=42 Participants • CHD summary for Season 2 participants only
|
181 Participants
n=262 Participants • CHD summary for Season 2 participants only
|
|
Chronic lung disease
Yes
|
0 Participants
CLD summary for Season 2 participants only
|
0 Participants
CLD summary for Season 2 participants only
|
132 Participants
n=180 Participants • CLD summary for Season 2 participants only
|
25 Participants
n=40 Participants • CLD summary for Season 2 participants only
|
32 Participants
n=42 Participants • CLD summary for Season 2 participants only
|
189 Participants
n=262 Participants • CLD summary for Season 2 participants only
|
|
Chronic lung disease
No
|
0 Participants
CLD summary for Season 2 participants only
|
0 Participants
CLD summary for Season 2 participants only
|
48 Participants
n=180 Participants • CLD summary for Season 2 participants only
|
15 Participants
n=40 Participants • CLD summary for Season 2 participants only
|
10 Participants
n=42 Participants • CLD summary for Season 2 participants only
|
73 Participants
n=262 Participants • CLD summary for Season 2 participants only
|
PRIMARY outcome
Timeframe: 360 days post first dosePopulation: As-treated population
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)
Outcome measures
| Measure |
MEDI8897
n=614 Participants
Subjects who received MEDI8897 in Season 1
|
Palivizumab
n=304 Participants
Subjects who received Palivizumab in Season 1
|
MEDI8897/MEDI8897
n=180 Participants
CHD/CLD subjects who were randomized to MEDI8897 group in Season 1 and remained in MEDI8897 group in Season 2.
|
Palivizumab/MEDI8897
n=40 Participants
CHD/CLD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to MEDI8897 group in Season 2
|
Palivizumab/Palivizumab
n=42 Participants
CHD/CLD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to Palivizumab group in Season 2.
|
|---|---|---|---|---|---|
|
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)
TEAE
|
444 Participants
|
215 Participants
|
130 Participants
|
31 Participants
|
29 Participants
|
|
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)
AESI
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
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)
NOCD
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
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)
TESAE
|
80 Participants
|
38 Participants
|
23 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 15, Day 31, Day 151 post first dose in Season 1 and Season 2Population: As-treated population
Summary of individual MEDI8897 and palivizumab serum concentration data by treatment group along with descriptive statistics.
Outcome measures
| Measure |
MEDI8897
n=614 Participants
Subjects who received MEDI8897 in Season 1
|
Palivizumab
n=304 Participants
Subjects who received Palivizumab in Season 1
|
MEDI8897/MEDI8897
n=180 Participants
CHD/CLD subjects who were randomized to MEDI8897 group in Season 1 and remained in MEDI8897 group in Season 2.
|
Palivizumab/MEDI8897
n=40 Participants
CHD/CLD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to MEDI8897 group in Season 2
|
Palivizumab/Palivizumab
n=42 Participants
CHD/CLD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to Palivizumab group in Season 2.
|
|---|---|---|---|---|---|
|
Serum Concentrations of MEDI8897 and Palivizumab
Serum concentrations of MEDI8897 and Palivizumab at Day 15
|
104.75 ug/mL
Geometric Coefficient of Variation 61.8
|
66.43 ug/mL
Geometric Coefficient of Variation 55.7
|
149.38 ug/mL
Geometric Coefficient of Variation 169.2
|
97.70 ug/mL
Geometric Coefficient of Variation 302.0
|
59.62 ug/mL
Geometric Coefficient of Variation 102.4
|
|
Serum Concentrations of MEDI8897 and Palivizumab
Serum concentrations of MEDI8897 and Palivizumab at Day 31
|
85.35 ug/mL
Geometric Coefficient of Variation 74.2
|
48.10 ug/mL
Geometric Coefficient of Variation 50.0
|
89.71 ug/mL
Geometric Coefficient of Variation 369.5
|
124.89 ug/mL
Geometric Coefficient of Variation 256.1
|
57.77 ug/mL
Geometric Coefficient of Variation 56.3
|
|
Serum Concentrations of MEDI8897 and Palivizumab
Serum concentrations of MEDI8897 and Palivizumab at Day 151
|
25.38 ug/mL
Geometric Coefficient of Variation 58.8
|
101.56 ug/mL
Geometric Coefficient of Variation 65.6
|
39.86 ug/mL
Geometric Coefficient of Variation 145.9
|
37.95 ug/mL
Geometric Coefficient of Variation 118.6
|
67.66 ug/mL
Geometric Coefficient of Variation 111.4
|
SECONDARY outcome
Timeframe: 360 days post first dosePopulation: Participants in as-treated population and with at least 1 post-baseline ADA sample
Incidence of ADA to MEDI8897 and palivizumab as assessed by the percentage of participants with any post-baseline ADA positive by treatment group.
Outcome measures
| Measure |
MEDI8897
n=587 Participants
Subjects who received MEDI8897 in Season 1
|
Palivizumab
n=289 Participants
Subjects who received Palivizumab in Season 1
|
MEDI8897/MEDI8897
n=180 Participants
CHD/CLD subjects who were randomized to MEDI8897 group in Season 1 and remained in MEDI8897 group in Season 2.
|
Palivizumab/MEDI8897
n=40 Participants
CHD/CLD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to MEDI8897 group in Season 2
|
Palivizumab/Palivizumab
n=42 Participants
CHD/CLD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to Palivizumab group in Season 2.
|
|---|---|---|---|---|---|
|
Incidence of Anti-drug Antibody (ADA) to MEDI8897 and Palivizumab in Serum
|
5.8 Percentage of participants
|
6.9 Percentage of participants
|
11.7 Percentage of participants
|
2.5 Percentage of participants
|
14.3 Percentage of participants
|
SECONDARY outcome
Timeframe: 150 days post first dosePopulation: ITT population
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.
Outcome measures
| Measure |
MEDI8897
n=616 Participants
Subjects who received MEDI8897 in Season 1
|
Palivizumab
n=309 Participants
Subjects who received Palivizumab in Season 1
|
MEDI8897/MEDI8897
n=180 Participants
CHD/CLD subjects who were randomized to MEDI8897 group in Season 1 and remained in MEDI8897 group in Season 2.
|
Palivizumab/MEDI8897
n=40 Participants
CHD/CLD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to MEDI8897 group in Season 2
|
Palivizumab/Palivizumab
n=42 Participants
CHD/CLD subjects who were randomized to Palivizumab group in Season 1 and re-randomized to Palivizumab group in Season 2.
|
|---|---|---|---|---|---|
|
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
Incidence of medically attended RSV LRTI through 150 days post first dose, %
|
0.6 Percentage of participants
|
1.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
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
Incidence of medically attended RSV LRTI with hospitalization through 150 days post first dose, %
|
0.3 Percentage of participants
|
0.6 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
MEDI8897
Serious events: 80 serious events
Other events: 435 other events
Deaths: 5 deaths
Palivizumab
Serious events: 38 serious events
Other events: 211 other events
Deaths: 1 deaths
MEDI8897/MEDI8897
Serious events: 23 serious events
Other events: 129 other events
Deaths: 0 deaths
Palivizumab/MEDI8897
Serious events: 4 serious events
Other events: 31 other events
Deaths: 0 deaths
Palivizumab/Palivizumab
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MEDI8897
n=614 participants at risk
Subjects who received MEDI8897 in Season 1.
|
Palivizumab
n=304 participants at risk
Subjects who received Palivizumab in Season 1.
|
MEDI8897/MEDI8897
n=180 participants at risk
CHD/CLD subjects who received MEDI8897 in both Season 1 and Season 2.
|
Palivizumab/MEDI8897
n=40 participants at risk
CLD/CHD subjects who received palivizumab in Season 1 and MEDI8897 in Season 2.
|
Palivizumab/Palivizumab
n=42 participants at risk
CLD/CHD subjects who received Palivizumab in both Season 1 and Season 2.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Gastric fistula
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Intussusception
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Crying
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Fatigue
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Hyperthermia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Oedema peripheral
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Pyrexia
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Adenovirus infection
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Cardiac disorders
Bradycardia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.66%
2/304 • Number of events 3 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Bacterial infection
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Bone abscess
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Bronchiolitis
|
1.8%
11/614 • Number of events 11 • 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.
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.
|
1.3%
4/304 • Number of events 4 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Bronchitis
|
0.81%
5/614 • Number of events 5 • 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.
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.
|
0.66%
2/304 • Number of events 2 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
1.7%
3/180 • Number of events 3 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Covid-19
|
0.49%
3/614 • Number of events 3 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
1.1%
2/180 • Number of events 2 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Dacryocystitis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Cardiac disorders
Cardiac failure
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.66%
2/304 • Number of events 2 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Ear infection
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Gastric infection
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Gastroenteritis
|
0.98%
6/614 • Number of events 6 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
1.7%
3/180 • Number of events 3 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Gastroenteritis viral
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.66%
2/304 • Number of events 2 • 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.
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.
|
1.1%
2/180 • Number of events 2 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Metapneumovirus bronchiolitis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Cardiac disorders
Cardiogenic shock
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Otitis media
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Pneumonia
|
0.81%
5/614 • Number of events 5 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
1.1%
2/180 • Number of events 2 • 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.
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.
|
5.0%
2/40 • Number of events 2 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Pneumonia viral
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Pyelonephritis
|
0.16%
1/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Pyelonephritis acute
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.65%
4/614 • Number of events 4 • 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.
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.
|
0.66%
2/304 • Number of events 2 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Scrotal infection
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Sepsis
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Septic shock
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
1.3%
4/304 • Number of events 5 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Urinary tract infection
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Varicella
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Viral infection
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.49%
3/614 • Number of events 4 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Investigations
Catheterisation cardiac
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Atrioventricular septal defect
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Feeding disorder
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Feeding intolerance
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Underweight
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Dyskinesia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Embolic stroke
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 2 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Hypotonia
|
0.16%
1/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Loss of consciousness
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Syncope
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Renal and urinary disorders
Calculus urinary
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Anaemic hypoxia
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Craniosynostosis
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragm muscle weakness
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Infantile apnoea
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
1.1%
2/180 • Number of events 2 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery stenosis
|
0.16%
1/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertensive crisis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Fallot's tetralogy
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Social circumstances
Social problem
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Social circumstances
Social stay hospitalisation
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Vascular disorders
Cyanosis
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Vascular malformation
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Eye disorders
Retinopathy of prematurity
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Anal fissure
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Ascites
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
Other adverse events
| Measure |
MEDI8897
n=614 participants at risk
Subjects who received MEDI8897 in Season 1.
|
Palivizumab
n=304 participants at risk
Subjects who received Palivizumab in Season 1.
|
MEDI8897/MEDI8897
n=180 participants at risk
CHD/CLD subjects who received MEDI8897 in both Season 1 and Season 2.
|
Palivizumab/MEDI8897
n=40 participants at risk
CLD/CHD subjects who received palivizumab in Season 1 and MEDI8897 in Season 2.
|
Palivizumab/Palivizumab
n=42 participants at risk
CLD/CHD subjects who received Palivizumab in both Season 1 and Season 2.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.7%
29/614 • Number of events 33 • 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.
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.
|
3.6%
11/304 • Number of events 12 • 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.
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.
|
5.6%
10/180 • Number of events 12 • 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.
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.
|
5.0%
2/40 • Number of events 3 • 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.
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.
|
16.7%
7/42 • Number of events 7 • 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.
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.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Dysbiosis
|
0.33%
2/614 • Number of events 3 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Dyschezia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.49%
3/614 • Number of events 3 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
1.1%
2/180 • Number of events 2 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Dysphagia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Enteritis
|
0.49%
3/614 • Number of events 4 • 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.
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.
|
0.66%
2/304 • Number of events 3 • 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.
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.
|
1.7%
3/180 • Number of events 5 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Faecaloma
|
0.33%
2/614 • Number of events 3 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Faeces pale
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Faeces soft
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Flatulence
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
1.6%
5/304 • Number of events 5 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Gastric fistula
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Gastritis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.66%
2/304 • Number of events 2 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.1%
13/614 • Number of events 13 • 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.
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.
|
3.0%
9/304 • Number of events 9 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Haematochezia
|
0.16%
1/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Ileus
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Infantile colic
|
1.5%
9/614 • Number of events 9 • 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.
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.
|
2.0%
6/304 • Number of events 6 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Infantile spitting up
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.49%
3/614 • Number of events 3 • 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.
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.
|
0.66%
2/304 • Number of events 2 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Stomatitis
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Teething
|
5.0%
31/614 • Number of events 35 • 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.
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.
|
5.3%
16/304 • Number of events 19 • 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.
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.
|
3.9%
7/180 • Number of events 7 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
4.8%
2/42 • Number of events 2 • 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.
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.
|
|
Gastrointestinal disorders
Tongue erythema
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/614 • 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.
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.
|
0.66%
2/304 • Number of events 3 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.66%
2/304 • Number of events 2 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
15/614 • Number of events 17 • 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.
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.
|
3.6%
11/304 • Number of events 14 • 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.
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.
|
3.3%
6/180 • Number of events 7 • 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.
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.
|
10.0%
4/40 • Number of events 5 • 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.
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.
|
7.1%
3/42 • Number of events 8 • 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.
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.
|
|
General disorders
Calcinosis
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Catheter site haematoma
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Developmental delay
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Discomfort
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 2 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Cardiac disorders
Atrial fibrillation
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Drug tolerance
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Drug withdrawal syndrome
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Fatigue
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Fever neonatal
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Hyperthermia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Impaired healing
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Incarcerated hernia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Injection site erythema
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Injection site induration
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Injection site reaction
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Medical device site irritation
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Medical device site rash
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Oedema
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Pain
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Peripheral swelling
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Pyrexia
|
13.2%
81/614 • Number of events 109 • 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.
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.
|
14.1%
43/304 • Number of events 57 • 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.
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.
|
12.8%
23/180 • Number of events 37 • 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.
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.
|
22.5%
9/40 • Number of events 12 • 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.
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.
|
14.3%
6/42 • Number of events 14 • 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.
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.
|
|
General disorders
Secretion discharge
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Swelling
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Vaccination site erythema
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Vaccination site reaction
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Vaccination site swelling
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
General disorders
Vaccination site urticaria
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Hepatobiliary disorders
Hepatitis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Hepatobiliary disorders
Jaundice
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Hepatobiliary disorders
Sphincter of oddi dysfunction
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Immune system disorders
Drug hypersensitivity
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Immune system disorders
Food allergy
|
0.98%
6/614 • Number of events 6 • 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.
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.
|
0.99%
3/304 • Number of events 3 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Immune system disorders
Milk allergy
|
0.98%
6/614 • Number of events 6 • 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.
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.
|
0.99%
3/304 • Number of events 3 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Immune system disorders
Nutritional supplement allergy
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Immune system disorders
Seasonal allergy
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
1.1%
2/180 • Number of events 2 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Acarodermatitis
|
0.65%
4/614 • Number of events 4 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Adenoiditis
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Infections and infestations
Anal fungal infection
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Bacterial blepharitis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Body tinea
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Bronchiolitis
|
3.6%
22/614 • Number of events 27 • 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.
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.
|
3.0%
9/304 • Number of events 12 • 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.
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.
|
5.0%
9/180 • Number of events 11 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
4.8%
2/42 • Number of events 2 • 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.
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.
|
|
Infections and infestations
Bronchitis
|
3.3%
20/614 • Number of events 28 • 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.
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.
|
3.3%
10/304 • Number of events 16 • 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.
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.
|
3.9%
7/180 • Number of events 7 • 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.
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.
|
10.0%
4/40 • Number of events 7 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Infections and infestations
Covid-19
|
1.3%
8/614 • Number of events 8 • 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.
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.
|
0.66%
2/304 • Number of events 2 • 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.
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.
|
7.8%
14/180 • Number of events 14 • 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.
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.
|
7.5%
3/40 • Number of events 3 • 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.
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.
|
11.9%
5/42 • Number of events 5 • 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.
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.
|
|
Infections and infestations
Candida infection
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.99%
3/304 • Number of events 5 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Candida nappy rash
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Cellulitis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Clostridium difficile infection
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Conjunctivitis
|
4.1%
25/614 • Number of events 31 • 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.
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.
|
3.3%
10/304 • Number of events 12 • 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.
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.
|
6.1%
11/180 • Number of events 11 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
7.1%
3/42 • Number of events 3 • 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.
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.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
1.1%
2/180 • Number of events 2 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Conjunctivitis viral
|
0.16%
1/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 2 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Coronavirus infection
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Croup infectious
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Dacryocystitis
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Dermatitis infected
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Device related sepsis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
12/614 • Number of events 12 • 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.
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.
|
1.6%
5/304 • Number of events 5 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/614 • 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.
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.
|
0.99%
3/304 • Number of events 3 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Ear infection
|
0.81%
5/614 • Number of events 8 • 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.
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.
|
1.6%
5/304 • Number of events 6 • 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.
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.
|
1.1%
2/180 • Number of events 3 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
4.8%
2/42 • Number of events 2 • 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.
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.
|
|
Infections and infestations
Enterobiasis
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 2 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Enterovirus infection
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Infections and infestations
Exanthema subitum
|
1.5%
9/614 • Number of events 9 • 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.
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.
|
1.3%
4/304 • Number of events 4 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Eye infection
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 2 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Fungal skin infection
|
1.1%
7/614 • Number of events 7 • 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.
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.
|
0.99%
3/304 • Number of events 3 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Gastroenteritis
|
3.1%
19/614 • Number of events 21 • 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.
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.
|
4.9%
15/304 • Number of events 15 • 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.
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.
|
6.1%
11/180 • Number of events 19 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
4.8%
2/42 • Number of events 3 • 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.
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.
|
|
Infections and infestations
Gastroenteritis adenovirus
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Gastroenteritis sapovirus
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Gastroenteritis viral
|
0.49%
3/614 • Number of events 3 • 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.
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.
|
0.66%
2/304 • Number of events 2 • 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.
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.
|
2.2%
4/180 • Number of events 4 • 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.
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.
|
5.0%
2/40 • Number of events 2 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Gastroenteritis yersinia
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Gastrointestinal bacterial overgrowth
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Gastrointestinal infection
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Giardiasis
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Foreign body in respiratory tract
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
2.4%
15/614 • Number of events 15 • 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.
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.
|
2.0%
6/304 • Number of events 6 • 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.
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.
|
5.0%
9/180 • Number of events 9 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
4.8%
2/42 • Number of events 2 • 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.
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.
|
|
Infections and infestations
Herpes virus infection
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Hordeolum
|
0.33%
2/614 • Number of events 3 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Human herpesvirus 6 infection
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
1.7%
3/180 • Number of events 3 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Impetigo
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Infection
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Infectious mononucleosis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Laryngitis
|
1.8%
11/614 • Number of events 12 • 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.
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.
|
2.3%
7/304 • Number of events 12 • 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.
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.
|
1.7%
3/180 • Number of events 4 • 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.
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.
|
5.0%
2/40 • Number of events 2 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Infections and infestations
Laryngopharyngitis
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Lice infestation
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Cardiac disorders
Cardiac septal hypertrophy
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.9%
18/614 • Number of events 21 • 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.
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.
|
3.3%
10/304 • Number of events 13 • 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.
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.
|
0.56%
1/180 • Number of events 3 • 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.
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.
|
7.5%
3/40 • Number of events 4 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.49%
3/614 • Number of events 3 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Infections and infestations
Nasopharyngitis
|
9.3%
57/614 • Number of events 84 • 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.
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.
|
12.8%
39/304 • Number of events 50 • 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.
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.
|
14.4%
26/180 • Number of events 55 • 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.
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.
|
17.5%
7/40 • Number of events 16 • 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.
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.
|
21.4%
9/42 • Number of events 15 • 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.
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.
|
|
Infections and infestations
Oral candidiasis
|
1.6%
10/614 • Number of events 10 • 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.
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.
|
2.0%
6/304 • Number of events 7 • 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.
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.
|
1.7%
3/180 • Number of events 3 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 2 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/614 • 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.
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.
|
0.99%
3/304 • Number of events 3 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Infections and infestations
Otitis media
|
4.4%
27/614 • Number of events 37 • 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.
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.
|
3.6%
11/304 • Number of events 14 • 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.
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.
|
6.7%
12/180 • Number of events 16 • 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.
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.
|
7.5%
3/40 • Number of events 3 • 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.
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.
|
4.8%
2/42 • Number of events 3 • 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.
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.
|
|
Infections and infestations
Otitis media acute
|
2.6%
16/614 • Number of events 20 • 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.
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.
|
4.6%
14/304 • Number of events 18 • 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.
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.
|
6.1%
11/180 • Number of events 19 • 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.
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.
|
12.5%
5/40 • Number of events 6 • 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.
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.
|
4.8%
2/42 • Number of events 4 • 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.
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.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Infections and infestations
Otitis media viral
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Otosalpingitis
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Pharyngitis
|
3.7%
23/614 • Number of events 29 • 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.
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.
|
2.6%
8/304 • Number of events 8 • 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.
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.
|
3.9%
7/180 • Number of events 9 • 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.
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.
|
5.0%
2/40 • Number of events 2 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 2 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Pneumonia
|
0.65%
4/614 • Number of events 4 • 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.
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.
|
0.99%
3/304 • Number of events 3 • 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.
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.
|
1.1%
2/180 • Number of events 2 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Cardiac disorders
Low cardiac output syndrome
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 2 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Pneumonia parainfluenzae viral
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Post procedural infection
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Pustule
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Pyelonephritis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Pyoderma
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.16%
1/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Rhinitis
|
12.2%
75/614 • Number of events 109 • 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.
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.
|
13.2%
40/304 • Number of events 64 • 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.
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.
|
16.1%
29/180 • Number of events 38 • 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.
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.
|
15.0%
6/40 • Number of events 8 • 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.
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.
|
14.3%
6/42 • Number of events 16 • 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.
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.
|
|
Infections and infestations
Roseola
|
1.3%
8/614 • Number of events 8 • 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.
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.
|
1.6%
5/304 • Number of events 5 • 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.
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.
|
1.7%
3/180 • Number of events 3 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
4.8%
2/42 • Number of events 2 • 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.
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.
|
|
Infections and infestations
Rotavirus infection
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Cardiac disorders
Pericardial effusion
|
0.33%
2/614 • Number of events 3 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Sepsis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Sinusitis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
1.1%
2/180 • Number of events 4 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Skin candida
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Skin infection
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Subglottic laryngitis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Superinfection viral
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Suspected covid-19
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
1.7%
3/180 • Number of events 3 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Tinea infection
|
0.33%
2/614 • Number of events 4 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Cardiac disorders
Right atrial dilatation
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Tonsillitis
|
0.49%
3/614 • Number of events 3 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
2.2%
4/180 • Number of events 4 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Infections and infestations
Tracheitis
|
0.49%
3/614 • Number of events 3 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
1.1%
2/180 • Number of events 2 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Infections and infestations
Tracheobronchitis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.99%
3/304 • Number of events 3 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
24.1%
148/614 • Number of events 235 • 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.
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.
|
25.3%
77/304 • Number of events 131 • 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.
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.
|
26.7%
48/180 • Number of events 86 • 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.
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.
|
20.0%
8/40 • Number of events 12 • 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.
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.
|
21.4%
9/42 • Number of events 26 • 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.
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.
|
|
Infections and infestations
Urinary tract infection
|
0.98%
6/614 • Number of events 8 • 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.
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.
|
0.99%
3/304 • Number of events 3 • 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.
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.
|
1.7%
3/180 • Number of events 3 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Varicella
|
0.81%
5/614 • Number of events 5 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
1.7%
3/180 • Number of events 3 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Viral infection
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.66%
2/304 • Number of events 2 • 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.
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.
|
1.1%
2/180 • Number of events 2 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Viral pharyngitis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/614 • 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.
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.
|
0.66%
2/304 • Number of events 2 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Viral rash
|
1.1%
7/614 • Number of events 7 • 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.
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.
|
0.99%
3/304 • Number of events 3 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Viral rhinitis
|
0.49%
3/614 • Number of events 3 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.4%
33/614 • Number of events 42 • 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.
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.
|
4.6%
14/304 • Number of events 15 • 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.
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.
|
7.8%
14/180 • Number of events 18 • 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.
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.
|
20.0%
8/40 • Number of events 8 • 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.
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.
|
4.8%
2/42 • Number of events 2 • 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.
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.
|
|
Infections and infestations
Vulvitis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Infections and infestations
Yersinia infection
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Accidental exposure to product
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.33%
2/614 • Number of events 3 • 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.
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.
|
0.99%
3/304 • Number of events 3 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Chillblains
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Blood and lymphatic system disorders
Anaemia neonatal
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.49%
3/614 • Number of events 3 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
1.1%
2/180 • Number of events 3 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.65%
4/614 • Number of events 4 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Intestinal anastomosis complication
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 2 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Cardiac disorders
Tachycardia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Penis injury
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Radial head dislocation
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Re-opening of ductus arteriosus
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.16%
1/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Injury, poisoning and procedural complications
Tooth avulsion
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
4.1%
25/614 • Number of events 36 • 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.
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.
|
6.2%
19/304 • Number of events 25 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
4.8%
2/42 • Number of events 2 • 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.
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.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Investigations
Blood albumin decreased
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Investigations
Body temperature abnormal
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Anomalous pulmonary venous connection
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Investigations
Body temperature increased
|
0.65%
4/614 • Number of events 4 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Investigations
Cardiac murmur
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Investigations
Coronavirus test positive
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Investigations
Crystal urine present
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Investigations
Echocardiogram
|
0.16%
1/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Investigations
Enterovirus test positive
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Investigations
Escherichia test positive
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Investigations
Haemophilus test positive
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Investigations
Head circumference abnormal
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Investigations
Herpes simplex test positive
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Investigations
Human rhinovirus test positive
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Investigations
Lymphocyte count decreased
|
0.16%
1/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Investigations
Platelet count decreased
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Investigations
Respiratory syncytial virus test positive
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Investigations
Sars-cov-2 test negative
|
3.1%
19/614 • Number of events 40 • 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.
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.
|
3.3%
10/304 • Number of events 15 • 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.
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.
|
2.2%
4/180 • Number of events 10 • 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.
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.
|
7.5%
3/40 • Number of events 5 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Investigations
Sars-cov-2 test positive
|
0.65%
4/614 • Number of events 4 • 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.
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.
|
0.99%
3/304 • Number of events 3 • 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.
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.
|
2.2%
4/180 • Number of events 4 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
4.8%
2/42 • Number of events 2 • 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.
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.
|
|
Investigations
Weight abnormal
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.49%
3/614 • Number of events 3 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.66%
2/304 • Number of events 2 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Feeding disorder
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Metabolism and nutrition disorders
Feeding intolerance
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Brachycephaly
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.66%
2/304 • Number of events 3 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Underweight
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Vitamin b12 deficiency
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Metabolism and nutrition disorders
Zinc deficiency
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Chest wall haematoma
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Cerebellar hypoplasia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Growth failure
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Myosclerosis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Rickets
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Cerebral ventricle dilatation
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Cerebral palsy
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Diplegia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Dyskinesia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Dystonia
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Febrile convulsion
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Hypotonia
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Infant irritability
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Cleft palate
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Motor developmental delay
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Posthaemorrhagic hydrocephalus
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Seizure
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Speech disorder developmental
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
4.8%
2/42 • Number of events 2 • 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.
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.
|
|
Nervous system disorders
Tremor
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Congenital choroid plexus cyst
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Product Issues
Device dislocation
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Psychiatric disorders
Agitation
|
0.49%
3/614 • Number of events 3 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Psychiatric disorders
Anxiety
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Psychiatric disorders
Drug dependence
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Psychiatric disorders
Irritability
|
0.98%
6/614 • Number of events 11 • 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.
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.
|
0.66%
2/304 • Number of events 3 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Psychiatric disorders
Restlessness
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Psychiatric disorders
Sleep terror
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Psychiatric disorders
Staring
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Congenital nystagmus
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Reproductive system and breast disorders
Enlarged clitoris
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Reproductive system and breast disorders
Genital labial adhesions
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Reproductive system and breast disorders
Scrotal dermatitis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Congenital oral malformation
|
0.00%
0/614 • 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.
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.
|
0.66%
2/304 • Number of events 2 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.16%
1/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.49%
3/614 • Number of events 3 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
1.1%
2/180 • Number of events 2 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
1.1%
2/180 • Number of events 2 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
0.49%
3/614 • Number of events 3 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
1.7%
3/180 • Number of events 4 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.33%
2/614 • Number of events 3 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.49%
3/614 • Number of events 4 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
1.7%
3/180 • Number of events 4 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory disease
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
16/614 • Number of events 18 • 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.
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.
|
2.0%
6/304 • Number of events 7 • 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.
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.
|
3.3%
6/180 • Number of events 6 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough variant asthma
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 2 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
41/614 • Number of events 53 • 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.
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.
|
4.3%
13/304 • Number of events 16 • 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.
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.
|
2.2%
4/180 • Number of events 5 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
1.1%
7/614 • Number of events 7 • 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.
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.
|
1.3%
4/304 • Number of events 5 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 2 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.66%
2/304 • Number of events 2 • 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.
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.
|
1.1%
2/180 • Number of events 2 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.99%
3/304 • Number of events 3 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertensive crisis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Cystic fibrosis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.66%
2/304 • Number of events 2 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.7%
23/614 • Number of events 28 • 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.
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.
|
3.9%
12/304 • Number of events 14 • 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.
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.
|
7.8%
14/180 • Number of events 25 • 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.
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.
|
10.0%
4/40 • Number of events 6 • 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.
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.
|
4.8%
2/42 • Number of events 4 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 4 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Dacryostenosis congenital
|
0.00%
0/614 • 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.
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.
|
0.66%
2/304 • Number of events 2 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Acne infantile
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Butterfly rash
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.1%
7/614 • Number of events 8 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
1.1%
2/180 • Number of events 2 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.49%
3/614 • Number of events 3 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Dysmorphism
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
2.3%
14/614 • Number of events 15 • 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.
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.
|
2.3%
7/304 • Number of events 7 • 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.
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.
|
1.7%
3/180 • Number of events 4 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.8%
11/614 • Number of events 12 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.56%
1/180 • Number of events 2 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
4.6%
28/614 • Number of events 29 • 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.
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.
|
2.0%
6/304 • Number of events 6 • 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.
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.
|
4.4%
8/180 • Number of events 9 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.3%
14/614 • Number of events 15 • 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.
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.
|
1.3%
4/304 • Number of events 4 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.3%
14/614 • Number of events 14 • 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.
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.
|
3.6%
11/304 • Number of events 14 • 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.
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.
|
2.2%
4/180 • Number of events 4 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Eczema infantile
|
1.6%
10/614 • Number of events 11 • 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.
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.
|
1.6%
5/304 • Number of events 5 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Eyelid ptosis congenital
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Erythema toxicum neonatorum
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Erythrosis
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
2.9%
18/614 • Number of events 18 • 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.
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.
|
3.6%
11/304 • Number of events 12 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Perioral dermatitis
|
0.49%
3/614 • Number of events 3 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.4%
21/614 • Number of events 21 • 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.
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.
|
3.0%
9/304 • Number of events 9 • 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.
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.
|
2.2%
4/180 • Number of events 4 • 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.
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.
|
5.0%
2/40 • Number of events 2 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.33%
2/614 • Number of events 3 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.65%
4/614 • Number of events 4 • 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.
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.
|
0.99%
3/304 • Number of events 3 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Rash neonatal
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.33%
2/614 • Number of events 3 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.49%
3/614 • Number of events 4 • 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.
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.
|
0.99%
3/304 • Number of events 3 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 2 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.66%
2/304 • Number of events 2 • 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.
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.
|
1.1%
2/180 • Number of events 2 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.81%
5/614 • Number of events 5 • 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.
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.
|
0.99%
3/304 • Number of events 3 • 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.
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.
|
1.7%
3/180 • Number of events 3 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Surgical and medical procedures
Adenoidectomy
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Surgical and medical procedures
Dacryocystorhinostomy
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Surgical and medical procedures
Ear operation
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Surgical and medical procedures
Ear tube insertion
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Surgical and medical procedures
Gastrostomy
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Surgical and medical procedures
Myringotomy
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Surgical and medical procedures
Orchidopexy
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Surgical and medical procedures
Tongue tie operation
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Vascular disorders
Capillary fragility
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Vascular disorders
Cyanosis
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Laryngomalacia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Vascular disorders
Haematoma
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
1.1%
2/180 • Number of events 2 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Vascular disorders
Hypertension
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Vascular disorders
Hypotension
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Left ventricle outflow tract obstruction
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.66%
2/304 • Number of events 2 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Congenital, familial and genetic disorders
Plagiocephaly
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.99%
3/304 • Number of events 3 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Congenital, familial and genetic disorders
Vascular malformation
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.49%
3/614 • Number of events 3 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Ear and labyrinth disorders
Deafness
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Ear and labyrinth disorders
Neurosensory hypoacusis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Ear and labyrinth disorders
Noninfective myringitis
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Eye disorders
Anisocoria
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Eye disorders
Anisometropia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Eye disorders
Astigmatism
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.66%
2/304 • Number of events 2 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Eye disorders
Blepharitis
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.56%
1/180 • Number of events 2 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
2.5%
1/40 • Number of events 1 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Eye disorders
Cataract
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Eye disorders
Chalazion
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Eye disorders
Choroidal effusion
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Eye disorders
Conjunctivitis allergic
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Eye disorders
Eye allergy
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Eye disorders
Eye discharge
|
0.16%
1/614 • Number of events 2 • 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.
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.
|
1.3%
4/304 • Number of events 5 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Eye disorders
Eye inflammation
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Blood and lymphatic system disorders
Monocytosis
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Eye disorders
Heterophoria
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Eye disorders
Hypermetropia
|
0.49%
3/614 • Number of events 3 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Eye disorders
Inflammation of lacrimal passage
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Eye disorders
Myopia
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Eye disorders
Periorbital swelling
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Eye disorders
Retinopathy
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Eye disorders
Retinopathy of prematurity
|
0.33%
2/614 • Number of events 2 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Eye disorders
Strabismus
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/614 • 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.
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.
|
0.66%
2/304 • Number of events 2 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
2.4%
1/42 • Number of events 1 • 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.
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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Anal erythema
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Anal fissure
|
0.16%
1/614 • Number of events 1 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Anal fissure haemorrhage
|
0.00%
0/614 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Ankyloglossia acquired
|
0.00%
0/614 • 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.
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.
|
0.33%
1/304 • Number of events 1 • 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.
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.
|
0.00%
0/180 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.65%
4/614 • Number of events 4 • 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.
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.
|
0.00%
0/304 • 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.
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.
|
0.56%
1/180 • Number of events 1 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/42 • 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.
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.
|
|
Gastrointestinal disorders
Constipation
|
6.0%
37/614 • Number of events 39 • 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.
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.
|
6.6%
20/304 • Number of events 28 • 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.
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.
|
2.8%
5/180 • Number of events 5 • 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.
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.
|
5.0%
2/40 • Number of events 2 • 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.
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.
|
4.8%
2/42 • Number of events 2 • 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.
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place