Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY) (NCT NCT03979313)
NCT ID: NCT03979313
Last Updated: 2024-02-28
Results Overview
Primary Endpoint Analysed on Primary Cohort Through 150 Days (N=1490 Participants)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3012 participants
Primary outcome timeframe
Through 150 Days Post Dose
Results posted on
2024-02-28
Participant Flow
First Subject In: 23-07-2019. Last Subject Last Visit: 21-03-2023. The study was planned to analyze data on the full enrolment of approximately 3000 infants. The impact of the COVID-19 pandemic on RSV circulation led to the decision to analyze the primary endpoint based on the first 1500 subjects enrolled (Primary Cohort). After the COVID-19 pandemic the study restarted. So the study comprised 2 cohorts: a Primary and a Safety for a total of 3319 screened subjects.
1626 screened subjects in Primary Cohort. 136 subjects did not start the study: 98 not meeting the I/E criteria, 6 lost to follow-up, 25 withdrew the informed consent, 7 for other reason. Overall 3319 screened subjects. 307 did not start the study: 192 not meeting the I/E criteria, 11 lost to follow-up, 90 withdrew the informed consent, 14 for other reason.
Participant milestones
| Measure |
Placebo
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
Medi8897
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
|---|---|---|
|
Primary Cohort (Data Cut Off 11/3/2021)
STARTED
|
496
|
994
|
|
Primary Cohort (Data Cut Off 11/3/2021)
Completed Day 151 Follow up
|
488
|
977
|
|
Primary Cohort (Data Cut Off 11/3/2021)
Completed Day 361 Follow up
|
453
|
914
|
|
Primary Cohort (Data Cut Off 11/3/2021)
Treated Participants
|
491
|
994
|
|
Primary Cohort (Data Cut Off 11/3/2021)
COMPLETED
|
43
|
89
|
|
Primary Cohort (Data Cut Off 11/3/2021)
NOT COMPLETED
|
453
|
905
|
|
All Subjects
STARTED
|
1003
|
2009
|
|
All Subjects
Completed Day 151 Follow up
|
985
|
1977
|
|
All Subjects
Completed Day 361 Follow up
|
967
|
1944
|
|
All Subjects
Treated Participants
|
997
|
1997
|
|
All Subjects
COMPLETED
|
923
|
1873
|
|
All Subjects
NOT COMPLETED
|
80
|
136
|
Reasons for withdrawal
| Measure |
Placebo
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
Medi8897
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
|---|---|---|
|
Primary Cohort (Data Cut Off 11/3/2021)
Lost to Follow-up
|
3
|
9
|
|
Primary Cohort (Data Cut Off 11/3/2021)
Any Other Reason
|
3
|
4
|
|
Primary Cohort (Data Cut Off 11/3/2021)
Death
|
0
|
4
|
|
Primary Cohort (Data Cut Off 11/3/2021)
Withdrawal by Subject
|
14
|
20
|
|
Primary Cohort (Data Cut Off 11/3/2021)
Covid-19 pandemic
|
1
|
3
|
|
Primary Cohort (Data Cut Off 11/3/2021)
Ongoing at the DCO date
|
432
|
865
|
|
All Subjects
Any Other Reason
|
16
|
23
|
|
All Subjects
Covid-19
|
1
|
3
|
|
All Subjects
Withdrawal by Subject
|
35
|
44
|
|
All Subjects
Death
|
0
|
5
|
|
All Subjects
Lost to Follow-up
|
28
|
61
|
Baseline Characteristics
Two analysis population data are shown: Primary Cohort and All Subjects
Baseline characteristics by cohort
| Measure |
Placebo
n=1003 Participants
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
Medi8897
n=2009 Participants
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
Total
n=3012 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age (months) in Primary Cohort
|
3.012 Months
STANDARD_DEVIATION 2.2520 • n=496 Participants • Two analysis population data are shown: Primary Cohort and All Subjects
|
2.912 Months
STANDARD_DEVIATION 2.2099 • n=994 Participants • Two analysis population data are shown: Primary Cohort and All Subjects
|
2.946 Months
STANDARD_DEVIATION 2.2237 • n=1490 Participants • Two analysis population data are shown: Primary Cohort and All Subjects
|
|
Age, Continuous
Age (months) in All Subjects
|
2.918 Months
STANDARD_DEVIATION 2.2740 • n=1003 Participants • Two analysis population data are shown: Primary Cohort and All Subjects
|
2.905 Months
STANDARD_DEVIATION 2.220 • n=2009 Participants • Two analysis population data are shown: Primary Cohort and All Subjects
|
2.909 Months
STANDARD_DEVIATION 2.2376 • n=3012 Participants • Two analysis population data are shown: Primary Cohort and All Subjects
|
|
Sex: Female, Male
Sex in Primary Cohort · Female
|
257 Participants
n=496 Participants • Two analysis population data are shown: Primary Cohort and All Subjects
|
464 Participants
n=994 Participants • Two analysis population data are shown: Primary Cohort and All Subjects
|
721 Participants
n=1490 Participants • Two analysis population data are shown: Primary Cohort and All Subjects
|
|
Sex: Female, Male
Sex in Primary Cohort · Male
|
239 Participants
n=496 Participants • Two analysis population data are shown: Primary Cohort and All Subjects
|
530 Participants
n=994 Participants • Two analysis population data are shown: Primary Cohort and All Subjects
|
769 Participants
n=1490 Participants • Two analysis population data are shown: Primary Cohort and All Subjects
|
|
Sex: Female, Male
Sex in All Subjects · Female
|
500 Participants
n=1003 Participants • Two analysis population data are shown: Primary Cohort and All Subjects
|
938 Participants
n=2009 Participants • Two analysis population data are shown: Primary Cohort and All Subjects
|
1438 Participants
n=3012 Participants • Two analysis population data are shown: Primary Cohort and All Subjects
|
|
Sex: Female, Male
Sex in All Subjects · Male
|
503 Participants
n=1003 Participants • Two analysis population data are shown: Primary Cohort and All Subjects
|
1071 Participants
n=2009 Participants • Two analysis population data are shown: Primary Cohort and All Subjects
|
1574 Participants
n=3012 Participants • Two analysis population data are shown: Primary Cohort and All Subjects
|
|
Race/Ethnicity, Customized
Race in Primary Cohort · American Indian or Alaska Native
|
26 Participants
n=496 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
57 Participants
n=994 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
83 Participants
n=1490 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
|
Race/Ethnicity, Customized
Race in Primary Cohort · Asian
|
18 Participants
n=496 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
36 Participants
n=994 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
54 Participants
n=1490 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
|
Race/Ethnicity, Customized
Race in Primary Cohort · Black or African American
|
136 Participants
n=496 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
286 Participants
n=994 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
422 Participants
n=1490 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
|
Race/Ethnicity, Customized
Race in Primary Cohort · Native Hawaiian or other Pacific Islander
|
5 Participants
n=496 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
6 Participants
n=994 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
11 Participants
n=1490 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
|
Race/Ethnicity, Customized
Race in Primary Cohort · White
|
272 Participants
n=496 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
524 Participants
n=994 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
796 Participants
n=1490 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
|
Race/Ethnicity, Customized
Race in Primary Cohort · Multiple categories checked
|
1 Participants
n=496 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
12 Participants
n=994 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
13 Participants
n=1490 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
|
Race/Ethnicity, Customized
Race in Primary Cohort · Other
|
38 Participants
n=496 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
70 Participants
n=994 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
108 Participants
n=1490 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
|
Race/Ethnicity, Customized
Race in Primary Cohort · Missing
|
0 Participants
n=496 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
3 Participants
n=994 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
3 Participants
n=1490 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
|
Race/Ethnicity, Customized
Race in All Subjects · American Indian or Alaska Native
|
52 Participants
n=1003 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
92 Participants
n=2009 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
144 Participants
n=3012 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
|
Race/Ethnicity, Customized
Race in All Subjects · Asian
|
50 Participants
n=1003 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
109 Participants
n=2009 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
159 Participants
n=3012 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
|
Race/Ethnicity, Customized
Race in All Subjects · Black or African American
|
138 Participants
n=1003 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
299 Participants
n=2009 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
437 Participants
n=3012 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
|
Race/Ethnicity, Customized
Race in All Subjects · Native Hawaiian or other Pacific Islander
|
8 Participants
n=1003 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
15 Participants
n=2009 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
23 Participants
n=3012 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
|
Race/Ethnicity, Customized
Race in All Subjects · White
|
541 Participants
n=1003 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
1052 Participants
n=2009 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
1593 Participants
n=3012 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
|
Race/Ethnicity, Customized
Race in All Subjects · Multiple categories checked
|
8 Participants
n=1003 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
19 Participants
n=2009 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
27 Participants
n=3012 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
|
Race/Ethnicity, Customized
Race in All Subjects · Other
|
206 Participants
n=1003 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
420 Participants
n=2009 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
626 Participants
n=3012 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
|
Race/Ethnicity, Customized
Race in All Subjects · Missing
|
0 Participants
n=1003 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
3 Participants
n=2009 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
3 Participants
n=3012 Participants • Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race
|
PRIMARY outcome
Timeframe: Through 150 Days Post DosePopulation: ITT population / Primary Cohort
Primary Endpoint Analysed on Primary Cohort Through 150 Days (N=1490 Participants)
Outcome measures
| Measure |
Placebo
n=496 Participants
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
Medi8897
n=994 Participants
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
|---|---|---|
|
Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort)
Observed events through day 150 post dose
|
25 Participants
|
12 Participants
|
|
Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort)
Subjects requiring imputation (Subjects without events and not followed through 150 days post dose)
|
6 Participants
|
15 Participants
|
|
Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort)
Subjects without event through day 150 post dose
|
465 Participants
|
967 Participants
|
SECONDARY outcome
Timeframe: Through 150 Days Post DosePopulation: ITT population / Primary Cohort
Hospitalization Analysed on Primary Cohort Through 150 Days (N=1490 Participants)
Outcome measures
| Measure |
Placebo
n=496 Participants
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
Medi8897
n=994 Participants
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
|---|---|---|
|
Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort)
Observed events through day 150 post dose
|
8 Participants
|
6 Participants
|
|
Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort)
Subjects requiring imputation (subjects without events and not followed through 150 days post dose)
|
6 Participants
|
15 Participants
|
|
Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort)
Subjects without event through day 150 post dose
|
482 Participants
|
973 Participants
|
SECONDARY outcome
Timeframe: By visit until day 360 post dosePopulation: As Treated Population (1997 Participants Treated in MEDI8897 arm)/ All Subjects
Number of Subjects with at Least one Assessment
Outcome measures
| Measure |
Placebo
n=799 Participants
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
Medi8897
n=1198 Participants
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
|---|---|---|
|
Summary of Serum Concentrations (ug/mL) of MEDI8897 by Group
Day 7 Post Dose
|
89.91 ug/mL
Geometric Coefficient of Variation 39.3
|
164.03 ug/mL
Geometric Coefficient of Variation 15.8
|
|
Summary of Serum Concentrations (ug/mL) of MEDI8897 by Group
Day 14 Post Dose
|
74.09 ug/mL
Geometric Coefficient of Variation 124.9
|
105.05 ug/mL
Geometric Coefficient of Variation 89.2
|
|
Summary of Serum Concentrations (ug/mL) of MEDI8897 by Group
Day 30 Post Dose
|
68.63 ug/mL
Geometric Coefficient of Variation 58.6
|
100.54 ug/mL
Geometric Coefficient of Variation 90.1
|
|
Summary of Serum Concentrations (ug/mL) of MEDI8897 by Group
Day 150 Post Dose
|
18.32 ug/mL
Geometric Coefficient of Variation 63.1
|
27.73 ug/mL
Geometric Coefficient of Variation 62.9
|
|
Summary of Serum Concentrations (ug/mL) of MEDI8897 by Group
Day 360 Post Dose
|
1.75 ug/mL
Geometric Coefficient of Variation 76.7
|
2.86 ug/mL
Geometric Coefficient of Variation 85.7
|
SECONDARY outcome
Timeframe: From baseline to 360 day post dose visitPopulation: As Treated Population / All Subjects
Number of subjects with a positive result and a valid titer result at the specific visit
Outcome measures
| Measure |
Placebo
n=968 Participants
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
Medi8897
n=1926 Participants
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
|---|---|---|
|
Anti-drug Antibody Results by Visit (As Treated Population)
Baseline
|
4 Participants
|
4 Participants
|
|
Anti-drug Antibody Results by Visit (As Treated Population)
Day 30 Post Dose
|
2 Participants
|
14 Participants
|
|
Anti-drug Antibody Results by Visit (As Treated Population)
Day 150 Post Dose
|
1 Participants
|
21 Participants
|
|
Anti-drug Antibody Results by Visit (As Treated Population)
Day 360 Post Dose
|
10 Participants
|
81 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through 150 Days Post DosePopulation: ITT population / All Subjects
Primary Endpoint Analysed on All Subjects Through 150 Days (N=3012 participants)
Outcome measures
| Measure |
Placebo
n=1003 Participants
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
Medi8897
n=2009 Participants
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
|---|---|---|
|
Number of Participants With MA RSV LRTI Through 150 Days Post Dose (All Subjects)
Observed events through day 150 post dose
|
54 Participants
|
24 Participants
|
|
Number of Participants With MA RSV LRTI Through 150 Days Post Dose (All Subjects)
Subjects requiring imputation (Subjects without events and not followed through 150 days post dose)
|
17 Participants
|
31 Participants
|
|
Number of Participants With MA RSV LRTI Through 150 Days Post Dose (All Subjects)
Subjects without event through day 150 post dose
|
932 Participants
|
1954 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through 150 Days Post DosePopulation: ITT population / All Subjects
Hospitalization Analysed on All Subjects Through 150 Days (N=3012 participants)
Outcome measures
| Measure |
Placebo
n=1003 Participants
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
Medi8897
n=2009 Participants
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
|---|---|---|
|
Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (All Subjects)
Observed events through day 150 post dose
|
20 Participants
|
9 Participants
|
|
Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (All Subjects)
Subjects requiring imputation (Subjects without events and not followed through 150 days post dose)
|
18 Participants
|
31 Participants
|
|
Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (All Subjects)
Subjects without event through day 150 post dose
|
965 Participants
|
1969 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Day 361 to Day 510 Post DosePopulation: ITT population / All Subjects
Outcome measures
| Measure |
Placebo
n=967 Participants
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
Medi8897
n=1944 Participants
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
|---|---|---|
|
Number of Participants With Disease From the 2nd RSV Season (All Subjects)
MA RSV LRTI (protocol defined)
|
10 Participants
|
19 Participants
|
|
Number of Participants With Disease From the 2nd RSV Season (All Subjects)
MA RSV LRTI hospitalisation (protocol defined)
|
3 Participants
|
3 Participants
|
Adverse Events
Placebo
Serious events: 83 serious events
Other events: 836 other events
Deaths: 0 deaths
MEDI8897
Serious events: 149 serious events
Other events: 1717 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Placebo
n=997 participants at risk
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
MEDI8897
n=1997 participants at risk
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
|---|---|---|
|
Congenital, familial and genetic disorders
Phenylketonuria
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Metabolism and nutrition disorders
Dairy intolerance
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Metabolism and nutrition disorders
Food refusal
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Facial paralysis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Idiopathic generalised epilepsy
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Seizure
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Psychiatric disorders
Behavioural insomnia of childhood
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Psychiatric disorders
Sleep terror
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Psychiatric disorders
Staring
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Vascular disorders
Kawasaki's disease
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Vascular disorders
Shock
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Allergic colitis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Allergic gastroenteritis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Colitis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Constipation
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Food poisoning
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Death
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Fever neonatal
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Pyrexia
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.30%
6/1997 • Number of events 6 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Immune system disorders
Milk allergy
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Abscess limb
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Abscess neck
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Abscess of external auditory meatus
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Adenoviral upper respiratory infection
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Bacterial sepsis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Botulism
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Bronchiolitis
|
1.7%
17/997 • Number of events 18 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
1.4%
27/1997 • Number of events 28 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Bronchitis
|
0.40%
4/997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Covid-19
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Covid-19 pneumonia
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Cellulitis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Bronchogenic cyst
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Exanthema subitum
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Gastroenteritis
|
0.50%
5/997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.70%
14/1997 • Number of events 15 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Gastroenteritis escherichia coli
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Gastroenteritis adenovirus
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Impetigo
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Infection
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Laryngitis
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.30%
6/1997 • Number of events 7 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Otitis media
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Pertussis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Pneumonia
|
0.50%
5/997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.65%
13/1997 • Number of events 14 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
1.0%
10/997 • Number of events 10 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.25%
5/1997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Staphylococcal scalded skin syndrome
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Streptococcal sepsis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Tonsillitis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Tracheobronchitis
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Urinary tract infection
|
0.50%
5/997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.35%
7/1997 • Number of events 7 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Viral infection
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Accidental exposure to product by child
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
Other adverse events
| Measure |
Placebo
n=997 participants at risk
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
MEDI8897
n=1997 participants at risk
Single IM dose of 50 mg (if \< 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
|
|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.4%
14/997 • Number of events 14 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
1.6%
31/1997 • Number of events 32 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Faeces soft
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Flatulence
|
0.40%
4/997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.65%
13/1997 • Number of events 13 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Food protein-induced enterocolitis syndrome
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Gastritis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Gingival cyst
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Gingival discomfort
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Gingival pain
|
0.10%
1/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Haematochezia
|
0.50%
5/997 • Number of events 6 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Infant dyschezia
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Infantile colic
|
1.1%
11/997 • Number of events 13 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
2.1%
41/1997 • Number of events 41 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Infantile spitting up
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Lip ulceration
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Mucous stools
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Oral mucosal eruption
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Stomatitis
|
0.40%
4/997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.35%
7/1997 • Number of events 7 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Teething
|
7.0%
70/997 • Number of events 85 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
6.9%
138/1997 • Number of events 171 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Toothache
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.30%
6/1997 • Number of events 12 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.40%
4/997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.70%
14/1997 • Number of events 14 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
32/997 • Number of events 35 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
3.0%
59/1997 • Number of events 63 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Asthenia
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Crying
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Developmental delay
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Discomfort
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.50%
10/1997 • Number of events 10 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Fatigue
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Gait disturbance
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Hypothermia
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Influenza like illness
|
0.40%
4/997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Injection site induration
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Injection site pain
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Injection site swelling
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Malaise
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Mass
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Pfapa syndrome
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Pain
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Peripheral swelling
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Pyrexia
|
12.2%
122/997 • Number of events 165 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
14.5%
290/1997 • Number of events 378 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Secretion discharge
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Cardiac disorders
Sinus tachycardia
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Vaccination site erythema
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Vaccination site pain
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Vaccination site reaction
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Vaccination site swelling
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
General disorders
Xerosis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.25%
5/1997 • Number of events 6 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Hepatobiliary disorders
Jaundice
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.35%
7/1997 • Number of events 7 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Immune system disorders
Allergy to arthropod bite
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.30%
6/1997 • Number of events 6 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Immune system disorders
Anaphylactic reaction
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Immune system disorders
Drug hypersensitivity
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.45%
9/1997 • Number of events 9 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Immune system disorders
Dust allergy
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Immune system disorders
Food allergy
|
1.8%
18/997 • Number of events 22 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
1.5%
30/1997 • Number of events 36 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Immune system disorders
Hypersensitivity
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Immune system disorders
Milk allergy
|
0.40%
4/997 • Number of events 7 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.35%
7/1997 • Number of events 7 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Immune system disorders
Multiple allergies
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Immune system disorders
Reaction to preservatives
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Immune system disorders
Seasonal allergy
|
0.60%
6/997 • Number of events 6 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.40%
8/1997 • Number of events 8 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Abscess
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Abscess jaw
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Abscess limb
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Abscess neck
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Acarodermatitis
|
1.5%
15/997 • Number of events 20 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
1.6%
32/1997 • Number of events 39 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Acute sinusitis
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Adenoviral upper respiratory infection
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.30%
6/1997 • Number of events 6 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Adenovirus infection
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Amoebiasis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Aorta hypoplasia
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Amoebic dysentery
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Anal abscess
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Ascariasis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Asymptomatic covid-19
|
0.70%
7/997 • Number of events 8 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.40%
8/1997 • Number of events 8 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Body tinea
|
1.2%
12/997 • Number of events 14 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
1.0%
20/1997 • Number of events 22 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Borrelia infection
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Bronchiolitis
|
7.1%
71/997 • Number of events 86 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
6.0%
119/1997 • Number of events 139 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Bronchitis
|
3.1%
31/997 • Number of events 34 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
3.0%
60/1997 • Number of events 76 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Bronchitis viral
|
0.20%
2/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Bullous impetigo
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.25%
5/1997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Covid-19
|
5.9%
59/997 • Number of events 62 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
4.9%
97/1997 • Number of events 98 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Candida infection
|
0.50%
5/997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Candida nappy rash
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.95%
19/1997 • Number of events 19 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Cellulitis
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.30%
6/1997 • Number of events 6 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Citrobacter infection
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Gastroenteritis viral
|
0.80%
8/997 • Number of events 11 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
1.1%
21/1997 • Number of events 23 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Conjunctivitis
|
5.6%
56/997 • Number of events 61 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
6.9%
137/1997 • Number of events 157 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.80%
8/997 • Number of events 8 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.65%
13/1997 • Number of events 13 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Brachycephaly
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.20%
2/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.30%
6/1997 • Number of events 6 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Croup infectious
|
0.70%
7/997 • Number of events 7 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.85%
17/1997 • Number of events 18 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Cystitis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Dacryocanaliculitis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Dacryocystitis
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Dermatitis infected
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Dermatophytosis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Diarrhoea infectious
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Dysentery
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Bronchogenic cyst
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Ear infection
|
0.40%
4/997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Ear infection bacterial
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Ear lobe infection
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Eczema infected
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Enterobiasis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Enterovirus infection
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Exanthema subitum
|
2.7%
27/997 • Number of events 27 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
1.5%
30/1997 • Number of events 30 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Eye infection
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.35%
7/1997 • Number of events 9 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Buried penis syndrome
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Febrile infection
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Folliculitis
|
0.40%
4/997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.70%
14/1997 • Number of events 15 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Fungal infection
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Fungal skin infection
|
1.9%
19/997 • Number of events 19 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
1.8%
35/1997 • Number of events 37 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Furuncle
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Gastroenteritis
|
10.0%
100/997 • Number of events 113 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
10.1%
202/1997 • Number of events 246 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Gastroenteritis adenovirus
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Congenital anomaly
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Gastroenteritis enteroviral
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Gastrointestinal infection
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Herpes ophthalmic
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Genital candidiasis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Genital infection fungal
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Gianotti-crosti syndrome
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
1.9%
19/997 • Number of events 19 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
2.1%
42/1997 • Number of events 43 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Congenital nystagmus
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Helminthic infection
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Herpangina
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.25%
5/1997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Hordeolum
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.25%
5/1997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Human herpesvirus 6 infection
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Impetigo
|
3.1%
31/997 • Number of events 35 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
2.2%
43/1997 • Number of events 47 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Infected bite
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Infected dermal cyst
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Infection
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Congenital tongue anomaly
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Influenza
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.45%
9/1997 • Number of events 10 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Joint abscess
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Laryngitis
|
0.90%
9/997 • Number of events 9 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
1.8%
35/1997 • Number of events 37 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Lice infestation
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Lower respiratory tract infection
|
3.4%
34/997 • Number of events 44 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
2.4%
47/1997 • Number of events 69 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Lower respiratory tract infection viral
|
1.2%
12/997 • Number of events 12 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.45%
9/1997 • Number of events 9 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Lyme disease
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Measles
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Meningitis aseptic
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Congenital torticollis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Molluscum contagiosum
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.45%
9/1997 • Number of events 10 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Nasopharyngitis
|
23.8%
237/997 • Number of events 471 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
22.1%
441/1997 • Number of events 946 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Omphalitis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Oral candidiasis
|
2.2%
22/997 • Number of events 23 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
2.8%
55/1997 • Number of events 60 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Oral herpes
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Oral infection
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Otitis externa
|
0.60%
6/997 • Number of events 6 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.30%
6/1997 • Number of events 6 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Otitis media
|
7.6%
76/997 • Number of events 111 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
7.7%
154/1997 • Number of events 218 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Congenital vesicoureteric reflux
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Pertussis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Otitis media acute
|
4.4%
44/997 • Number of events 53 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
4.1%
82/1997 • Number of events 126 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Otitis media chronic
|
0.10%
1/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Paronychia
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.55%
11/1997 • Number of events 12 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Pharyngitis
|
2.8%
28/997 • Number of events 28 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
3.6%
72/1997 • Number of events 80 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Pharyngotonsillitis
|
0.90%
9/997 • Number of events 9 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.80%
16/1997 • Number of events 16 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Pneumonia
|
0.60%
6/997 • Number of events 6 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.55%
11/1997 • Number of events 11 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Pneumonia moraxella
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Pustule
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Pyelonephritis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Pyoderma
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Dacryostenosis congenital
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.80%
16/1997 • Number of events 16 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Pyoderma streptococcal
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Rash pustular
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
1.4%
14/997 • Number of events 14 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.65%
13/1997 • Number of events 13 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Rhinitis
|
10.2%
102/997 • Number of events 146 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
10.1%
201/1997 • Number of events 272 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Rhinolaryngitis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Roseola
|
1.4%
14/997 • Number of events 14 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
1.2%
24/1997 • Number of events 24 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Blood and lymphatic system disorders
Anaemia neonatal
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Scarlet fever
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Sinusitis
|
0.70%
7/997 • Number of events 7 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.45%
9/1997 • Number of events 9 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Sinusitis bacterial
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Skin candida
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.45%
9/1997 • Number of events 9 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Skin infection
|
0.20%
2/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Subcutaneous abscess
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Developmental hip dysplasia
|
0.40%
4/997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Subglottic laryngitis
|
0.20%
2/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Suspected covid-19
|
0.70%
7/997 • Number of events 7 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.50%
10/1997 • Number of events 10 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Tinea capitis
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Tinea cruris
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Tinea infection
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Tinea pedis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Tinea versicolour
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Tonsillitis
|
0.70%
7/997 • Number of events 7 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.70%
14/1997 • Number of events 15 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Tracheitis
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Tracheobronchitis
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Upper respiratory tract infection
|
31.7%
316/997 • Number of events 621 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
32.0%
639/1997 • Number of events 1316 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Urinary tract infection
|
1.4%
14/997 • Number of events 15 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
1.1%
22/1997 • Number of events 26 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Vaccination site infection
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Varicella
|
1.0%
10/997 • Number of events 10 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
1.1%
22/1997 • Number of events 22 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Varicella zoster virus infection
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Viral diarrhoea
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Viral infection
|
2.1%
21/997 • Number of events 22 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
1.8%
35/1997 • Number of events 36 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Viral pharyngitis
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.45%
9/1997 • Number of events 9 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Klippel-feil syndrome
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Viral rash
|
3.0%
30/997 • Number of events 32 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
4.3%
85/1997 • Number of events 90 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Viral tonsillitis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.0%
60/997 • Number of events 77 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
6.6%
132/1997 • Number of events 162 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Infections and infestations
Wound infection
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
2.2%
22/997 • Number of events 24 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
1.4%
27/1997 • Number of events 31 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Laryngomalacia
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Chemical burn
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.55%
11/1997 • Number of events 11 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Macrocephaly
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.30%
6/1997 • Number of events 6 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Eyelid injury
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Face injury
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Fall
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Foreign body in ear
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Mitochondrial encephalomyopathy
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Foreign body in respiratory tract
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Foreign body in throat
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Foreign body ingestion
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Gingival injury
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.60%
6/997 • Number of events 7 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.80%
16/1997 • Number of events 17 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Muscle contusion
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Nasal injury
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Oral contusion
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Post procedural erythema
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Radial head dislocation
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Scratch
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.40%
8/1997 • Number of events 8 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.50%
5/997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.45%
9/1997 • Number of events 10 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
3.4%
34/997 • Number of events 47 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
3.6%
72/1997 • Number of events 90 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Injury, poisoning and procedural complications
Vulvovaginal injury
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Investigations
Blood copper increased
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Investigations
Blood immunoglobulin e increased
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.70%
7/997 • Number of events 8 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.65%
13/1997 • Number of events 13 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Plagiocephaly
|
0.40%
4/997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.55%
11/1997 • Number of events 11 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Investigations
Blood lead increased
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Investigations
Body temperature increased
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.25%
5/1997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Investigations
Cardiac murmur
|
0.40%
4/997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.25%
5/1997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Investigations
Cardiac murmur functional
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Investigations
Echocardiogram abnormal
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Investigations
Haemoglobin decreased
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Investigations
Liver function test abnormal
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Investigations
Medical observation normal
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Investigations
Neutrophil count decreased
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Investigations
Platelet count increased
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Investigations
Sars-cov-2 test negative
|
2.7%
27/997 • Number of events 30 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
2.4%
48/1997 • Number of events 58 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Investigations
Sars-cov-2 test positive
|
0.40%
4/997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Investigations
Transaminases increased
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Pityriasis alba
|
0.40%
4/997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.50%
10/1997 • Number of events 10 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Metabolism and nutrition disorders
Breast milk substitute intolerance
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Metabolism and nutrition disorders
Dairy intolerance
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.50%
5/997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.30%
6/1997 • Number of events 6 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Talipes
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.25%
5/1997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Metabolism and nutrition disorders
Poor feeding infant
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Metabolism and nutrition disorders
Underweight
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Metabolism and nutrition disorders
Vitamin b12 deficiency
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Telangiectasia congenital
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.50%
5/997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.35%
7/1997 • Number of events 7 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Musculoskeletal and connective tissue disorders
Acquired plagiocephaly
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Musculoskeletal and connective tissue disorders
Diastasis recti abdominis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Musculoskeletal and connective tissue disorders
Growth retardation
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Musculoskeletal and connective tissue disorders
Head deformity
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Vascular malformation
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Musculoskeletal and connective tissue disorders
Posture abnormal
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Musculoskeletal and connective tissue disorders
Rib deformity
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cartilage neoplasm
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.10%
1/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.45%
9/1997 • Number of events 9 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Epulis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Chorea
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Febrile convulsion
|
0.50%
5/997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Gross motor delay
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Horner's syndrome
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Hypertonia
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Hypotonia
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Idiopathic partial epilepsy
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Infant irritability
|
0.40%
4/997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Motor developmental delay
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Post-traumatic epilepsy
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Psychomotor skills impaired
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Seizure
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Seizure like phenomena
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Somnolence
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Speech disorder developmental
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Nervous system disorders
Tremor
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Pregnancy, puerperium and perinatal conditions
Small for dates baby
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical granuloma
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Psychiatric disorders
Anxiety
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Psychiatric disorders
Irritability
|
1.1%
11/997 • Number of events 11 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
1.1%
22/1997 • Number of events 26 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Psychiatric disorders
Poor quality sleep
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Ear and labyrinth disorders
Ear pain
|
0.70%
7/997 • Number of events 8 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.60%
12/1997 • Number of events 14 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Psychiatric disorders
Sleep disorder
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.30%
6/1997 • Number of events 6 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Reproductive system and breast disorders
Breast enlargement
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Reproductive system and breast disorders
Genital discomfort
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Reproductive system and breast disorders
Genital labial adhesions
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Reproductive system and breast disorders
Genital pain
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Reproductive system and breast disorders
Genital ulceration
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Reproductive system and breast disorders
Penile adhesion
|
0.50%
5/997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.30%
6/1997 • Number of events 6 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Reproductive system and breast disorders
Penile discharge
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Reproductive system and breast disorders
Penile erythema
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Reproductive system and breast disorders
Testicular mass
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Reproductive system and breast disorders
Vulvovaginal adhesion
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.80%
8/997 • Number of events 8 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.70%
14/1997 • Number of events 14 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Reproductive system and breast disorders
Vulvovaginal erythema
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 6 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Brief resolved unexplained event
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.80%
8/997 • Number of events 12 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.65%
13/1997 • Number of events 13 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Childhood asthma
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.8%
58/997 • Number of events 69 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
5.8%
115/1997 • Number of events 145 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 7 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.6%
86/997 • Number of events 113 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
8.2%
164/1997 • Number of events 208 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.50%
5/997 • Number of events 7 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.90%
18/1997 • Number of events 19 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.2%
12/997 • Number of events 15 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.65%
13/1997 • Number of events 14 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.5%
65/997 • Number of events 85 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
7.6%
152/1997 • Number of events 216 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Ear and labyrinth disorders
Tympanic membrane hyperaemia
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.25%
5/1997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Tracheomalacia
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.35%
7/1997 • Number of events 8 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.20%
2/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.30%
6/1997 • Number of events 11 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract irritation
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Endocrine disorders
Hypothyroidism
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Vasomotor rhinitis
|
0.50%
5/997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.60%
12/1997 • Number of events 15 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.40%
4/997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.25%
5/1997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Acne infantile
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Cafe au lait spots
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.1%
21/997 • Number of events 22 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
2.2%
44/1997 • Number of events 44 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.50%
5/997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.55%
11/1997 • Number of events 12 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
2.5%
25/997 • Number of events 28 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
2.8%
56/1997 • Number of events 59 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Eye disorders
Astigmatism
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.6%
16/997 • Number of events 18 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
2.0%
39/1997 • Number of events 41 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
10.3%
103/997 • Number of events 118 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
11.2%
224/1997 • Number of events 267 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Dermatosis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.9%
19/997 • Number of events 19 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
2.0%
39/1997 • Number of events 41 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.2%
52/997 • Number of events 59 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
4.5%
90/1997 • Number of events 98 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.30%
6/1997 • Number of events 6 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Eczema infantile
|
0.90%
9/997 • Number of events 11 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
1.1%
21/1997 • Number of events 23 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Eye disorders
Blepharitis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Ephelides
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.40%
4/997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Erythema toxicum neonatorum
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.25%
5/1997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Idiopathic urticaria
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.40%
4/997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.25%
5/1997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Lichen striatus
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
3.7%
37/997 • Number of events 47 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
3.0%
60/1997 • Number of events 71 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Perioral dermatitis
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Post inflammatory pigmentation change
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.30%
6/1997 • Number of events 6 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.8%
48/997 • Number of events 55 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
4.7%
93/1997 • Number of events 108 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.80%
8/997 • Number of events 8 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.85%
17/1997 • Number of events 17 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.80%
8/997 • Number of events 8 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.75%
15/1997 • Number of events 15 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
1.7%
17/997 • Number of events 17 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
2.0%
40/1997 • Number of events 40 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Eye disorders
Conjunctival hyperaemia
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.30%
6/1997 • Number of events 6 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.75%
15/1997 • Number of events 18 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Thermal burn
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Transient neonatal pustular melanosis
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.90%
9/997 • Number of events 11 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
1.1%
21/1997 • Number of events 25 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Urticaria chronic
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Urticaria contact
|
0.10%
1/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Surgical and medical procedures
Circumcision
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Eye disorders
Conjunctivitis allergic
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.30%
6/1997 • Number of events 6 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Surgical and medical procedures
Clamping of blood vessel
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Surgical and medical procedures
Infection prophylaxis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Surgical and medical procedures
Oral surgery
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Surgical and medical procedures
Scrotal operation
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Surgical and medical procedures
Skin lesion removal
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Surgical and medical procedures
Urethral repair
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Vascular disorders
Cyanosis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Vascular disorders
Pallor
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Vascular disorders
Phlebitis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Eye disorders
Dacryostenosis acquired
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Eye disorders
Eye discharge
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.30%
6/1997 • Number of events 6 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Eye disorders
Eye swelling
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Eye disorders
Hypermetropia
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Eye disorders
Keratitis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Eye disorders
Lacrimal structural disorder
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.20%
4/1997 • Number of events 4 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Eye disorders
Periorbital oedema
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Eye disorders
Pseudostrabismus
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Eye disorders
Pterygium
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Eye disorders
Pupillary disorder
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Eye disorders
Strabismus
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.25%
5/1997 • Number of events 5 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Abdominal mass
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.35%
7/1997 • Number of events 7 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Aerophagia
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Anal fissure
|
0.30%
3/997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.30%
6/1997 • Number of events 6 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Anal polyp
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Auriculotemporal syndrome
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Constipation
|
3.8%
38/997 • Number of events 42 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
4.4%
88/1997 • Number of events 96 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Diarrhoea
|
8.9%
89/997 • Number of events 104 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
8.6%
171/1997 • Number of events 196 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.10%
2/1997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.15%
3/1997 • Number of events 3 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Faecaloma
|
0.10%
1/997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.00%
0/1997 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.20%
2/997 • Number of events 2 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
0.05%
1/1997 • Number of events 1 • All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place