Trial Outcomes & Findings for Repeat Ivermectin Mass Drug Administrations for MALaria Control II (NCT NCT03967054)
NCT ID: NCT03967054
Last Updated: 2025-04-10
Results Overview
Incidence of malaria episodes in enrolled village children ≤ 10 years of age
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4124 participants
Primary outcome timeframe
up to 8 months
Results posted on
2025-04-10
Participant Flow
Potential clusters (villages) within the Diebougou Health district, Burkina Faso, were identified from a catchment area based on access, safety of the study team, potential for contamination, and cluster size, and invited to participant via an extensive community engagement process.
Unit of analysis: villages
Participant milestones
| Measure |
Ivermectin Mass Drug Administration
Ivermectin given monthly from July-October (4 times) as a 3-day course of 300 µg/kg/day to all eligible persons per exclusion/inclusion criteria. Per package insert, dosing of IVM will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; \>158 cm = 4 tablet/day for 3 days.
Ivermectin: Ivermectin (6 mg tablet) given monthly from July-October each rainy season as a 3-day course of approximately 300 mcg/kg/day as estimated by height bands.
|
Placebo Mass Administration
Placebo given monthly from July-October (4 times) as a 3-day course to all eligible persons per exclusion/inclusion criteria. Dosing of placebo will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; \>158 cm = 4 tablet/day for 3 days.
Placebo oral tablet: placebo in the same size, color and shape at the ivermectin tablet
|
|---|---|---|
|
Overall Study
STARTED
|
2191 7
|
1933 7
|
|
Overall Study
COMPLETED
|
2191 7
|
1933 7
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Repeat Ivermectin Mass Drug Administrations for MALaria Control II
Baseline characteristics by cohort
| Measure |
Ivermectin Mass Drug Administration
n=2191 Participants
Ivermectin given monthly from July-October (4 times) as a 3-day course of 300 µg/kg/day to all eligible persons per exclusion/inclusion criteria. Per package insert, dosing of IVM will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; \>158 cm = 4 tablet/day for 3 days.
Ivermectin: Ivermectin (6 mg tablet) given monthly from July-October each rainy season as a 3-day course of approximately 300 mcg/kg/day as estimated by height bands.
|
Placebo Mass Administration
n=1933 Participants
Placebo given monthly from July-October (4 times) as a 3-day course to all eligible persons per exclusion/inclusion criteria. Dosing of placebo will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; \>158 cm = 4 tablet/day for 3 days.
Placebo oral tablet: placebo in the same size, color and shape at the ivermectin tablet
|
Total
n=4124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
17 years
n=5 Participants
|
15 years
n=7 Participants
|
16 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1100 Participants
n=5 Participants
|
1024 Participants
n=7 Participants
|
2124 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1091 Participants
n=5 Participants
|
909 Participants
n=7 Participants
|
2000 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
|
2191 Participants
n=5 Participants
|
1933 Participants
n=7 Participants
|
4124 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
Burkina Faso
|
2191 participants
n=5 Participants
|
1933 participants
n=7 Participants
|
4124 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 8 monthsPopulation: The primary outcome measure comes only from malaria incidence measurements within a cohort of village children (1531). It is not a measure of malaria incidence from all enrolled participants from the study villages. The majority of participants (1133/1531) within the child cohort were evaluated in both years, meaning that they contributed a malaria case count for both year 1 and year 2.
Incidence of malaria episodes in enrolled village children ≤ 10 years of age
Outcome measures
| Measure |
Ivermectin Mass Drug Administration
n=795 Participants
Ivermectin given monthly from July-October (4 times) as a 3-day course of 300 µg/kg/day to all eligible persons per exclusion/inclusion criteria. Per package insert, dosing of IVM will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; \>158 cm = 4 tablet/day for 3 days.
Ivermectin: Ivermectin (6 mg tablet) given monthly from July-October each rainy season as a 3-day course of approximately 300 mcg/kg/day as estimated by height bands.
|
Placebo Mass Administration
n=736 Participants
Placebo given monthly from July-October (4 times) as a 3-day course to all eligible persons per exclusion/inclusion criteria. Dosing of placebo will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; \>158 cm = 4 tablet/day for 3 days.
Placebo oral tablet: placebo in the same size, color and shape at the ivermectin tablet
|
|---|---|---|
|
Malaria Incidence
|
0.0176 Malaria cases per person-week
Interval 0.0124 to 0.0252
|
0.0183 Malaria cases per person-week
Interval 0.0128 to 0.0262
|
SECONDARY outcome
Timeframe: up to 8 monthsNumber adverse events among the study population over the course of the intervention period. Note, this number includes all malaria cases that were part of the primary outcome that occurred in the cohort of children that were actively assessed for malaria on a weekly basis during the intervention.
Outcome measures
| Measure |
Ivermectin Mass Drug Administration
n=2191 Participants
Ivermectin given monthly from July-October (4 times) as a 3-day course of 300 µg/kg/day to all eligible persons per exclusion/inclusion criteria. Per package insert, dosing of IVM will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; \>158 cm = 4 tablet/day for 3 days.
Ivermectin: Ivermectin (6 mg tablet) given monthly from July-October each rainy season as a 3-day course of approximately 300 mcg/kg/day as estimated by height bands.
|
Placebo Mass Administration
n=1933 Participants
Placebo given monthly from July-October (4 times) as a 3-day course to all eligible persons per exclusion/inclusion criteria. Dosing of placebo will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; \>158 cm = 4 tablet/day for 3 days.
Placebo oral tablet: placebo in the same size, color and shape at the ivermectin tablet
|
|---|---|---|
|
Adverse Events
|
438 adverse events
|
402 adverse events
|
SECONDARY outcome
Timeframe: up to 8 monthsPopulation: This analysis population is not human participants but mosquitoes captured from participants' homes. These are blood fed Anopheles gambiae s.l. mosquitoes captured indoors in participants' home 1 week following each mass drug administration.
Number of Blood Fed Mosquitoes Alive For 3 Days After Capture
Outcome measures
| Measure |
Ivermectin Mass Drug Administration
n=660 mosquitoes
Ivermectin given monthly from July-October (4 times) as a 3-day course of 300 µg/kg/day to all eligible persons per exclusion/inclusion criteria. Per package insert, dosing of IVM will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; \>158 cm = 4 tablet/day for 3 days.
Ivermectin: Ivermectin (6 mg tablet) given monthly from July-October each rainy season as a 3-day course of approximately 300 mcg/kg/day as estimated by height bands.
|
Placebo Mass Administration
n=1258 mosquitoes
Placebo given monthly from July-October (4 times) as a 3-day course to all eligible persons per exclusion/inclusion criteria. Dosing of placebo will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; \>158 cm = 4 tablet/day for 3 days.
Placebo oral tablet: placebo in the same size, color and shape at the ivermectin tablet
|
|---|---|---|
|
Survival Rate of Blood Fed Mosquitoes
|
399 mosquitoes
|
896 mosquitoes
|
Adverse Events
Ivermectin Mass Drug Administration
Serious events: 8 serious events
Other events: 430 other events
Deaths: 6 deaths
Placebo Mass Administration
Serious events: 6 serious events
Other events: 396 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Ivermectin Mass Drug Administration
n=2191 participants at risk
Ivermectin given monthly from July-October (4 times) as a 3-day course of 300 µg/kg/day to all eligible persons per exclusion/inclusion criteria. Per package insert, dosing of IVM will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; \>158 cm = 4 tablet/day for 3 days.
Ivermectin: Ivermectin (6 mg tablet) given monthly from July-October each rainy season as a 3-day course of approximately 300 mcg/kg/day as estimated by height bands.
|
Placebo Mass Administration
n=1933 participants at risk
Placebo given monthly from July-October (4 times) as a 3-day course to all eligible persons per exclusion/inclusion criteria. Dosing of placebo will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; \>158 cm = 4 tablet/day for 3 days.
Placebo oral tablet: placebo in the same size, color and shape at the ivermectin tablet
|
|---|---|---|
|
Infections and infestations
cellulitis
|
0.05%
1/2191 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.05%
1/1933 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Renal and urinary disorders
nephrotic syndrome
|
0.00%
0/2191 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.05%
1/1933 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Pregnancy, puerperium and perinatal conditions
spontaneous abortion
|
0.05%
1/2191 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.05%
1/1933 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/2191 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.05%
1/1933 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Metabolism and nutrition disorders
failure to thrive
|
0.05%
1/2191 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.05%
1/1933 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Hepatobiliary disorders
liver cirrhosis
|
0.05%
1/2191 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.00%
0/1933 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Hepatobiliary disorders
liver failure
|
0.05%
1/2191 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.05%
1/1933 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Injury, poisoning and procedural complications
head trauma
|
0.05%
1/2191 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.00%
0/1933 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Renal and urinary disorders
renal failure
|
0.05%
1/2191 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.00%
0/1933 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Infections and infestations
sepsis
|
0.05%
1/2191 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.00%
0/1933 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
Other adverse events
| Measure |
Ivermectin Mass Drug Administration
n=2191 participants at risk
Ivermectin given monthly from July-October (4 times) as a 3-day course of 300 µg/kg/day to all eligible persons per exclusion/inclusion criteria. Per package insert, dosing of IVM will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; \>158 cm = 4 tablet/day for 3 days.
Ivermectin: Ivermectin (6 mg tablet) given monthly from July-October each rainy season as a 3-day course of approximately 300 mcg/kg/day as estimated by height bands.
|
Placebo Mass Administration
n=1933 participants at risk
Placebo given monthly from July-October (4 times) as a 3-day course to all eligible persons per exclusion/inclusion criteria. Dosing of placebo will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; \>158 cm = 4 tablet/day for 3 days.
Placebo oral tablet: placebo in the same size, color and shape at the ivermectin tablet
|
|---|---|---|
|
Infections and infestations
malaria
|
16.2%
355/2191 • Number of events 466 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
15.9%
308/1933 • Number of events 436 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Gastrointestinal disorders
abdominal pain
|
0.05%
1/2191 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.10%
2/1933 • Number of events 2 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Skin and subcutaneous tissue disorders
abcess
|
0.00%
0/2191 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.10%
2/1933 • Number of events 2 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/2191 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.31%
6/1933 • Number of events 6 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Injury, poisoning and procedural complications
bite wound
|
0.00%
0/2191 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.10%
2/1933 • Number of events 2 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Eye disorders
blurry vision
|
0.05%
1/2191 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.00%
0/1933 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Reproductive system and breast disorders
breast tenderness
|
0.05%
1/2191 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.00%
0/1933 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Reproductive system and breast disorders
breast cancer
|
0.05%
1/2191 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.00%
0/1933 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Injury, poisoning and procedural complications
burn
|
0.05%
1/2191 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.10%
2/1933 • Number of events 2 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Infections and infestations
cellulitis
|
0.00%
0/2191 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.05%
1/1933 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
General disorders
chills
|
0.00%
0/2191 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.05%
1/1933 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Eye disorders
conjunctivitis
|
0.05%
1/2191 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.10%
2/1933 • Number of events 2 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Infections and infestations
cough
|
0.00%
0/2191 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.05%
1/1933 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Gastrointestinal disorders
diarrhea
|
0.27%
6/2191 • Number of events 6 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.36%
7/1933 • Number of events 7 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Ear and labyrinth disorders
dizziness
|
0.23%
5/2191 • Number of events 5 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.00%
0/1933 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Gastrointestinal disorders
dysphagia
|
0.05%
1/2191 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.10%
2/1933 • Number of events 2 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
General disorders
edema
|
0.09%
2/2191 • Number of events 2 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.05%
1/1933 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
General disorders
failure to thrive
|
0.05%
1/2191 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.00%
0/1933 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
General disorders
fatigue
|
0.09%
2/2191 • Number of events 2 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.00%
0/1933 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
General disorders
fever
|
0.50%
11/2191 • Number of events 11 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.52%
10/1933 • Number of events 10 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Gastrointestinal disorders
gastric ulcer
|
0.00%
0/2191 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.05%
1/1933 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Gastrointestinal disorders
gastroenteritis
|
0.14%
3/2191 • Number of events 3 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.05%
1/1933 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Gastrointestinal disorders
gastrointestinal reflux disease
|
0.05%
1/2191 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.00%
0/1933 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Nervous system disorders
headache
|
0.27%
6/2191 • Number of events 6 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.31%
6/1933 • Number of events 6 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Skin and subcutaneous tissue disorders
hives
|
0.09%
2/2191 • Number of events 2 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.05%
1/1933 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
General disorders
hypersensitivity
|
0.05%
1/2191 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.00%
0/1933 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Injury, poisoning and procedural complications
injury
|
0.00%
0/2191 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.05%
1/1933 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Musculoskeletal and connective tissue disorders
lower back pain
|
0.00%
0/2191 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.16%
3/1933 • Number of events 3 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
General disorders
myalgia
|
0.05%
1/2191 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.10%
2/1933 • Number of events 2 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Ear and labyrinth disorders
otalgia
|
0.00%
0/2191 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.31%
6/1933 • Number of events 6 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Ear and labyrinth disorders
otitis media
|
0.05%
1/2191 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.16%
3/1933 • Number of events 3 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
General disorders
pain
|
0.00%
0/2191 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.26%
5/1933 • Number of events 5 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Infections and infestations
pharyngitis
|
0.05%
1/2191 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.00%
0/1933 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Injury, poisoning and procedural complications
procedural
|
0.00%
0/2191 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.05%
1/1933 • Number of events 1 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Skin and subcutaneous tissue disorders
pruritis
|
0.41%
9/2191 • Number of events 9 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
1.0%
20/1933 • Number of events 20 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Skin and subcutaneous tissue disorders
rash
|
0.23%
5/2191 • Number of events 5 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.62%
12/1933 • Number of events 12 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Injury, poisoning and procedural complications
snake bite
|
0.18%
4/2191 • Number of events 4 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.10%
2/1933 • Number of events 2 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Injury, poisoning and procedural complications
trauma
|
0.18%
4/2191 • Number of events 4 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.36%
7/1933 • Number of events 7 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Infections and infestations
upper respiratory infection
|
0.59%
13/2191 • Number of events 13 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
1.3%
26/1933 • Number of events 29 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Ear and labyrinth disorders
vertigo
|
0.14%
3/2191 • Number of events 3 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.00%
0/1933 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/2191 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
0.10%
2/1933 • Number of events 3 • Adverse events were recorded over the intervention period, which occurred over two 4-month intervals of 2 consecutive rainy seasons in 2019 and 2020 (8 total months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place