Trial Outcomes & Findings for Mortality Reduction After Oral Azithromycin: Mortality Study (NCT NCT02047981)
NCT ID: NCT02047981
Last Updated: 2022-11-08
Results Overview
This is a single multi-site trial, with each country as a secondary analysis. Also, an interim analysis of efficacy and futility will be conducted according to a pre-specified plan in the Statistical Analysis Plan.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
190238 participants
Primary outcome timeframe
24 Months
Results posted on
2022-11-08
Participant Flow
Participant milestones
| Measure |
Biannual Mass Oral Azithromycin
Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years.
In Niger during year 3, all communities will be offered azithroymcin.
Azithromycin: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
|
Biannual Mass Oral Placebo
Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years
In Niger during year 3, all communities will be offered azithroymcin.
Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
|
|---|---|---|
|
MORDOR Stage I Year 1-2
STARTED
|
97047
|
93191
|
|
MORDOR Stage I Year 1-2
COMPLETED
|
87650
|
84474
|
|
MORDOR Stage I Year 1-2
NOT COMPLETED
|
9397
|
8717
|
|
MORDOR Stage II Year 3
STARTED
|
37497
|
33294
|
|
MORDOR Stage II Year 3
COMPLETED
|
34611
|
30931
|
|
MORDOR Stage II Year 3
NOT COMPLETED
|
2886
|
2363
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mortality Reduction After Oral Azithromycin: Mortality Study
Baseline characteristics by cohort
| Measure |
Biannual Mass Oral Azithromycin
n=97047 Participants
Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years.
In Niger during year 3, all communities will be offered azithroymcin.
Azithromycin: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
|
Biannual Mass Oral Placebo
n=93191 Participants
Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years
In Niger during year 3, all communities will be offered azithroymcin.
Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
|
Total
n=190238 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age group · 1-5 months
|
7135 Participants
n=5 Participants
|
6870 Participants
n=7 Participants
|
14005 Participants
n=5 Participants
|
|
Age, Customized
Age group · 6-11 months
|
12777 Participants
n=5 Participants
|
12318 Participants
n=7 Participants
|
25095 Participants
n=5 Participants
|
|
Age, Customized
Age group · 12-23 months
|
18557 Participants
n=5 Participants
|
17886 Participants
n=7 Participants
|
36443 Participants
n=5 Participants
|
|
Age, Customized
Age group · 24-59 months
|
58578 Participants
n=5 Participants
|
56117 Participants
n=7 Participants
|
114695 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
47901 Participants
n=5 Participants
|
46019 Participants
n=7 Participants
|
93920 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49146 Participants
n=5 Participants
|
47172 Participants
n=7 Participants
|
96318 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
97047 Participants
n=5 Participants
|
93191 Participants
n=7 Participants
|
190238 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Niger
|
40345 participants
n=5 Participants
|
35747 participants
n=7 Participants
|
76092 participants
n=5 Participants
|
|
Region of Enrollment
Malawi
|
39386 participants
n=5 Participants
|
39534 participants
n=7 Participants
|
78920 participants
n=5 Participants
|
|
Region of Enrollment
Tanzania
|
17316 participants
n=5 Participants
|
17910 participants
n=7 Participants
|
35226 participants
n=5 Participants
|
|
Number of communities
|
762 communities
n=5 Participants
|
750 communities
n=7 Participants
|
1512 communities
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 MonthsThis is a single multi-site trial, with each country as a secondary analysis. Also, an interim analysis of efficacy and futility will be conducted according to a pre-specified plan in the Statistical Analysis Plan.
Outcome measures
| Measure |
Biannual Mass Oral Azithromycin
n=97047 Participants
Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years.
In Niger during year 3, all communities will be offered azithroymcin.
Azithromycin: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
|
Biannual Mass Oral Placebo
n=93191 Participants
Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years
In Niger during year 3, all communities will be offered azithroymcin.
Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
|
|---|---|---|
|
All-cause Mortality Rate in Children Aged 1-60 Months
|
14.6 deaths per 1000 person-years
|
16.5 deaths per 1000 person-years
|
PRIMARY outcome
Timeframe: 36 monthsThis was a pre-specified contingency study in Niger only in which all communities were treated with mass azithromycin during the third year of the study following the primary 24-month endpoint.
Outcome measures
| Measure |
Biannual Mass Oral Azithromycin
n=37497 Participants
Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years.
In Niger during year 3, all communities will be offered azithroymcin.
Azithromycin: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
|
Biannual Mass Oral Placebo
n=33294 Participants
Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years
In Niger during year 3, all communities will be offered azithroymcin.
Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
|
|---|---|---|
|
All-cause Mortality Rate in Children Aged 1-60 Months
|
23.3 deaths per 1000 person-years
Interval 21.4 to 25.5
|
24.0 deaths per 1000 person-years
Interval 22.1 to 26.3
|
SECONDARY outcome
Timeframe: 24 MonthsDeaths were assessed via biannual population census. A pre-specified outcome was cause of death, assessed by verbal autopsy.
Outcome measures
| Measure |
Biannual Mass Oral Azithromycin
n=40345 Participants
Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years.
In Niger during year 3, all communities will be offered azithroymcin.
Azithromycin: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
|
Biannual Mass Oral Placebo
n=35747 Participants
Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years
In Niger during year 3, all communities will be offered azithroymcin.
Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
|
|---|---|---|
|
Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Niger Only)
Injury
|
0.22 Deaths per 1000 person years
Interval 0.14 to 0.36
|
0.23 Deaths per 1000 person years
Interval 0.14 to 0.38
|
|
Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Niger Only)
Malnutrition
|
0.39 Deaths per 1000 person years
Interval 0.26 to 0.59
|
0.42 Deaths per 1000 person years
Interval 0.28 to 0.63
|
|
Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Niger Only)
AIDS
|
0.12 Deaths per 1000 person years
Interval 0.06 to 0.23
|
0.12 Deaths per 1000 person years
Interval 0.06 to 0.24
|
|
Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Niger Only)
Measles
|
0.30 Deaths per 1000 person years
Interval 0.19 to 0.46
|
0.28 Deaths per 1000 person years
Interval 0.17 to 0.45
|
|
Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Niger Only)
Meningitis
|
0.82 Deaths per 1000 person years
Interval 0.63 to 1.09
|
1.22 Deaths per 1000 person years
Interval 0.96 to 1.57
|
|
Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Niger Only)
Dysentery
|
0.74 Deaths per 1000 person years
Interval 0.55 to 0.98
|
1.14 Deaths per 1000 person years
Interval 0.88 to 1.47
|
|
Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Niger Only)
Diarrhea
|
3.01 Deaths per 1000 person years
Interval 2.59 to 3.49
|
3.60 Deaths per 1000 person years
Interval 3.11 to 4.17
|
|
Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Niger Only)
Pertussis
|
0.04 Deaths per 1000 person years
Interval 0.01 to 0.12
|
0.04 Deaths per 1000 person years
Interval 0.01 to 0.14
|
|
Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Niger Only)
Pneumonia
|
3.27 Deaths per 1000 person years
Interval 2.85 to 3.75
|
3.96 Deaths per 1000 person years
Interval 3.46 to 4.53
|
|
Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Niger Only)
Malaria
|
5.60 Deaths per 1000 person years
Interval 4.97 to 6.32
|
7.22 Deaths per 1000 person years
Interval 6.43 to 8.11
|
|
Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Niger Only)
Hemorrhagic fever
|
0.08 Deaths per 1000 person years
Interval 0.03 to 0.17
|
0.06 Deaths per 1000 person years
Interval 0.02 to 0.16
|
|
Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Niger Only)
Other infection
|
4.24 Deaths per 1000 person years
Interval 3.7 to 4.85
|
5.06 Deaths per 1000 person years
Interval 4.44 to 5.78
|
|
Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Niger Only)
Unspecified
|
1.43 Deaths per 1000 person years
Interval 1.17 to 1.75
|
1.81 Deaths per 1000 person years
Interval 1.49 to 2.19
|
|
Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Niger Only)
Total
|
22.3 Deaths per 1000 person years
Interval 20.9 to 23.9
|
27.3 Deaths per 1000 person years
Interval 25.5 to 29.1
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: all children 1-59 months treated
Cost-effectiveness of Mass Azithromycin Administration, Per Averted Childhood Death during the 24 month phase
Outcome measures
| Measure |
Biannual Mass Oral Azithromycin
n=32369 Participants
Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years.
In Niger during year 3, all communities will be offered azithroymcin.
Azithromycin: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
|
Biannual Mass Oral Placebo
n=32370 Participants
Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years
In Niger during year 3, all communities will be offered azithroymcin.
Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
|
|---|---|---|
|
Cost-effectiveness of Mass Azithromycin Administration, Per Averted Childhood Death
|
853 usd per death averted
Interval 581.0 to 1719.0
|
0 usd per death averted
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Number of children visiting health centers
We recorded clinic visits one year prior the study and during the first year of the study and collected outcomes of these visit.
Outcome measures
| Measure |
Biannual Mass Oral Azithromycin
n=12875 Participants
Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years.
In Niger during year 3, all communities will be offered azithroymcin.
Azithromycin: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
|
Biannual Mass Oral Placebo
n=12809 Participants
Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years
In Niger during year 3, all communities will be offered azithroymcin.
Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
|
|---|---|---|
|
All-cause and Cause-specific Health Clinic Visits in 1-60 Month-old Children
|
5229 post-treatment clinical visits
|
7647 post-treatment clinical visits
|
SECONDARY outcome
Timeframe: 24 MonthsAt 6-monthly intervals a census of the communities was conducted, and for child deaths a verbal autopsy was performed to ascertain the cause using a standardized diagnostic classification. Mortality due to pneumonia or diarrhea by age group and arm are shown in the outcome measure data table below.
Outcome measures
| Measure |
Biannual Mass Oral Azithromycin
n=17316 Participants
Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years.
In Niger during year 3, all communities will be offered azithroymcin.
Azithromycin: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
|
Biannual Mass Oral Placebo
n=17910 Participants
Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years
In Niger during year 3, all communities will be offered azithroymcin.
Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
|
|---|---|---|
|
Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Tanzania Only)
Age group Mortality: 1- 5 months
|
0.46 deaths per 100 person-years
|
0.90 deaths per 100 person-years
|
|
Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Tanzania Only)
Age group Mortality: 6- 11 months
|
0.47 deaths per 100 person-years
|
0.56 deaths per 100 person-years
|
|
Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Tanzania Only)
Age group Mortality: 12 - 23 months
|
0.29 deaths per 100 person-years
|
0.29 deaths per 100 person-years
|
|
Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Tanzania Only)
Age group Mortality: 24 - 59 months
|
0.15 deaths per 100 person-years
|
0.10 deaths per 100 person-years
|
SECONDARY outcome
Timeframe: 24 MonthsCause-specific mortality by intention-to-treat for the four main inferred causes of death in the study area.
Outcome measures
| Measure |
Biannual Mass Oral Azithromycin
n=39386 Participants
Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years.
In Niger during year 3, all communities will be offered azithroymcin.
Azithromycin: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
|
Biannual Mass Oral Placebo
n=39534 Participants
Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years
In Niger during year 3, all communities will be offered azithroymcin.
Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
|
|---|---|---|
|
Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Malawi Only)
Pneumonia
|
1.15 deaths per 1000 person-years
Interval 0.92 to 1.44
|
1.40 deaths per 1000 person-years
Interval 1.15 to 1.72
|
|
Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Malawi Only)
Malaria
|
3.68 deaths per 1000 person-years
Interval 3.25 to 4.17
|
3.84 deaths per 1000 person-years
Interval 3.4 to 4.34
|
|
Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Malawi Only)
HIV/AIDS
|
1.06 deaths per 1000 person-years
Interval 0.84 to 1.34
|
1.54 deaths per 1000 person-years
Interval 1.27 to 1.87
|
|
Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Malawi Only)
Diarrhoea
|
0.67 deaths per 1000 person-years
Interval 0.5 to 0.9
|
0.72 deaths per 1000 person-years
Interval 0.54 to 0.95
|
Adverse Events
Biannual Mass Oral Azithromycin
Serious events: 3273 serious events
Other events: 0 other events
Deaths: 3262 deaths
Biannual Mass Oral Placebo
Serious events: 3400 serious events
Other events: 0 other events
Deaths: 3392 deaths
Serious adverse events
| Measure |
Biannual Mass Oral Azithromycin
n=97047 participants at risk
Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years.
In Niger during year 3, all communities will be offered azithroymcin.
Azithromycin: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
|
Biannual Mass Oral Placebo
n=93191 participants at risk
Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years
In Niger during year 3, all communities will be offered azithroymcin.
Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
|
|---|---|---|
|
Gastrointestinal disorders
Suspected ileus
|
0.00%
1/97047 • Number of events 1 • 36 months.
A SAE is any adverse event that: * Results in death * Is life-threatening (i.e., causes an immediate risk of death) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity * Results in a congenital anomaly or birth defect Or that is considered to be: · An important medical event SAE reporting excludes mortality as measured for the primary outcome.
|
0.00%
0/93191 • 36 months.
A SAE is any adverse event that: * Results in death * Is life-threatening (i.e., causes an immediate risk of death) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity * Results in a congenital anomaly or birth defect Or that is considered to be: · An important medical event SAE reporting excludes mortality as measured for the primary outcome.
|
|
General disorders
Suspected dehydration
|
0.00%
0/97047 • 36 months.
A SAE is any adverse event that: * Results in death * Is life-threatening (i.e., causes an immediate risk of death) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity * Results in a congenital anomaly or birth defect Or that is considered to be: · An important medical event SAE reporting excludes mortality as measured for the primary outcome.
|
0.00%
2/93191 • Number of events 2 • 36 months.
A SAE is any adverse event that: * Results in death * Is life-threatening (i.e., causes an immediate risk of death) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity * Results in a congenital anomaly or birth defect Or that is considered to be: · An important medical event SAE reporting excludes mortality as measured for the primary outcome.
|
|
Infections and infestations
Malaria
|
0.00%
4/97047 • Number of events 4 • 36 months.
A SAE is any adverse event that: * Results in death * Is life-threatening (i.e., causes an immediate risk of death) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity * Results in a congenital anomaly or birth defect Or that is considered to be: · An important medical event SAE reporting excludes mortality as measured for the primary outcome.
|
0.00%
3/93191 • Number of events 3 • 36 months.
A SAE is any adverse event that: * Results in death * Is life-threatening (i.e., causes an immediate risk of death) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity * Results in a congenital anomaly or birth defect Or that is considered to be: · An important medical event SAE reporting excludes mortality as measured for the primary outcome.
|
|
General disorders
Coma
|
0.00%
1/97047 • Number of events 1 • 36 months.
A SAE is any adverse event that: * Results in death * Is life-threatening (i.e., causes an immediate risk of death) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity * Results in a congenital anomaly or birth defect Or that is considered to be: · An important medical event SAE reporting excludes mortality as measured for the primary outcome.
|
0.00%
0/93191 • 36 months.
A SAE is any adverse event that: * Results in death * Is life-threatening (i.e., causes an immediate risk of death) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity * Results in a congenital anomaly or birth defect Or that is considered to be: · An important medical event SAE reporting excludes mortality as measured for the primary outcome.
|
|
Respiratory, thoracic and mediastinal disorders
ARI
|
0.00%
0/97047 • 36 months.
A SAE is any adverse event that: * Results in death * Is life-threatening (i.e., causes an immediate risk of death) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity * Results in a congenital anomaly or birth defect Or that is considered to be: · An important medical event SAE reporting excludes mortality as measured for the primary outcome.
|
0.00%
2/93191 • Number of events 2 • 36 months.
A SAE is any adverse event that: * Results in death * Is life-threatening (i.e., causes an immediate risk of death) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity * Results in a congenital anomaly or birth defect Or that is considered to be: · An important medical event SAE reporting excludes mortality as measured for the primary outcome.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
1/97047 • Number of events 1 • 36 months.
A SAE is any adverse event that: * Results in death * Is life-threatening (i.e., causes an immediate risk of death) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity * Results in a congenital anomaly or birth defect Or that is considered to be: · An important medical event SAE reporting excludes mortality as measured for the primary outcome.
|
0.00%
0/93191 • 36 months.
A SAE is any adverse event that: * Results in death * Is life-threatening (i.e., causes an immediate risk of death) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity * Results in a congenital anomaly or birth defect Or that is considered to be: · An important medical event SAE reporting excludes mortality as measured for the primary outcome.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/97047 • 36 months.
A SAE is any adverse event that: * Results in death * Is life-threatening (i.e., causes an immediate risk of death) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity * Results in a congenital anomaly or birth defect Or that is considered to be: · An important medical event SAE reporting excludes mortality as measured for the primary outcome.
|
0.00%
1/93191 • Number of events 1 • 36 months.
A SAE is any adverse event that: * Results in death * Is life-threatening (i.e., causes an immediate risk of death) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity * Results in a congenital anomaly or birth defect Or that is considered to be: · An important medical event SAE reporting excludes mortality as measured for the primary outcome.
|
|
General disorders
|
0.00%
4/97047 • Number of events 4 • 36 months.
A SAE is any adverse event that: * Results in death * Is life-threatening (i.e., causes an immediate risk of death) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity * Results in a congenital anomaly or birth defect Or that is considered to be: · An important medical event SAE reporting excludes mortality as measured for the primary outcome.
|
0.00%
0/93191 • 36 months.
A SAE is any adverse event that: * Results in death * Is life-threatening (i.e., causes an immediate risk of death) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity * Results in a congenital anomaly or birth defect Or that is considered to be: · An important medical event SAE reporting excludes mortality as measured for the primary outcome.
|
|
General disorders
Death
|
3.4%
3262/97047 • Number of events 3262 • 36 months.
A SAE is any adverse event that: * Results in death * Is life-threatening (i.e., causes an immediate risk of death) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity * Results in a congenital anomaly or birth defect Or that is considered to be: · An important medical event SAE reporting excludes mortality as measured for the primary outcome.
|
3.6%
3392/93191 • Number of events 3392 • 36 months.
A SAE is any adverse event that: * Results in death * Is life-threatening (i.e., causes an immediate risk of death) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity * Results in a congenital anomaly or birth defect Or that is considered to be: · An important medical event SAE reporting excludes mortality as measured for the primary outcome.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place