Trial Outcomes & Findings for Repeat Ivermectin Mass Drug Administrations for Control of Malaria: a Pilot Safety and Efficacy Study (NCT NCT02509481)

Last Updated: 2019-01-04

Results Overview

Cumulative incidence of malaria episodes in a cohort of village children ≤ 5 years of age (as assessed by active case surveillance in study villages - malaria episode defined as ≥38.0°C fever or history of fever in the last 24 hours + positive rapid diagnostic test for Plasmodium falciparum). Incidence is reported as malaria episodes per child over the course of the trial, a higher incidence is a worse outcome.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

2712 participants

Primary outcome timeframe

Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm

Results posted on

2019-01-04

Participant Flow

2712 participants from 8 villages were recruited to participate and enrolled. Importantly, the intervention (repeated ivermectin MDA) was given to most villagers and the safety outcome was assessed in this whole group. However, the primary outcome was assessed in a cohort of 590 enrolled village children ≤5 years old.

Participant milestones

Participant milestones
Measure	Single MDA Single mass drug administration of ivermectin (150 µg/kg) + albendazole (400 mg) performed after the start of the rainy season as part of public health efforts to eliminate lymphatic filariasis. Ivermectin Albendazole	Repeated MDA Same as Active Comparator, but then followed by five more mass drug administrations of ivermectin only (150 µg/kg) every three weeks thereafter. Ivermectin Albendazole
Overall Study STARTED	1265	1447
Overall Study COMPLETED	1265	1447
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Repeat Ivermectin Mass Drug Administrations for Control of Malaria: a Pilot Safety and Efficacy Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single MDA n=1265 Participants Single mass drug administration of ivermectin (150 µg/kg) + albendazole (400 mg) performed after the start of the rainy season as part of public health efforts to eliminate lymphatic filariasis. Ivermectin Albendazole	Repeated MDA n=1447 Participants Same as Active Comparator, but then followed by five more mass drug administrations of ivermectin only (150 µg/kg) every three weeks thereafter. Ivermectin Albendazole	Total n=2712 Participants Total of all reporting groups
Age, Continuous	14 years n=5 Participants	16 years n=7 Participants	15 years n=5 Participants
Sex: Female, Male Female	620 Participants n=5 Participants	713 Participants n=7 Participants	1333 Participants n=5 Participants
Sex: Female, Male Male	645 Participants n=5 Participants	734 Participants n=7 Participants	1379 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	1265 Participants n=5 Participants	1447 Participants n=7 Participants	2712 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	1265 Participants n=5 Participants	1447 Participants n=7 Participants	2712 Participants n=5 Participants
Height <90 cm	210 Participants n=5 Participants	267 Participants n=7 Participants	477 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm

Population: Note that the primary outcome measure comes only from malaria incidence measurements within this child cohort (590 children). It is not a measure of malaria incidence from all enrolled participants from the study villages (2712 participants).

Outcome measures

Outcome measures
Measure	Single MDA n=263 Participants Single mass drug administration of ivermectin (150 µg/kg) + albendazole (400 mg) performed after the start of the rainy season as part of public health efforts to eliminate lymphatic filariasis. Ivermectin Albendazole	Repeated MDA n=327 Participants Same as Active Comparator, but then followed by five more mass drug administrations of ivermectin only (150 µg/kg) every three weeks thereafter. Ivermectin Albendazole
Incidence of Clinical Malaria Episodes	2.49 episodes Interval 2.28 to 2.73	2.00 episodes Interval 1.82 to 2.2

SECONDARY outcome

Timeframe: Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm

Population: Per protocol, the secondary outcome was a measure of all adverse events, excluding uncomplicated malaria episodes that were reported in the primary outcome, that occurred among the total enrolled population from the study villages (2712 participants).

The number of adverse events. Adverse events data were collected via passive case detection from total population.

Outcome measures

Outcome measures
Measure	Single MDA n=1265 Participants Single mass drug administration of ivermectin (150 µg/kg) + albendazole (400 mg) performed after the start of the rainy season as part of public health efforts to eliminate lymphatic filariasis. Ivermectin Albendazole	Repeated MDA n=1447 Participants Same as Active Comparator, but then followed by five more mass drug administrations of ivermectin only (150 µg/kg) every three weeks thereafter. Ivermectin Albendazole
Adverse Events	24 adverse events	45 adverse events

SECONDARY outcome

Timeframe: Approximately 20 weeks, from before the start of the first MDA to 4 weeks following the last MDA in the Experimental arm

Population: We sampled finger capillary blood pre-intervention from a subset of enrolled participants located in 8 households at the center of each study village, and then re-sampled their blood immediately after the intervention period. Data were reported only from participants that gave both sets of samples (221 of 2712 participants).

Change in human IgG reactivity (optical density; ∆OD) to an Anopheles salivary gland antigen (peptide gSG6-P1) over the trial period. A score of 0 indicates no change in seroreactivity from from immediately before to immediately after the trial, suggesting consistent mosquito biting throughout the trial. A positive score indicates increasing seroreactivity and thus increasing mosquito biting on participants from immediately before to immediately after the trial. A negative score indicates decreasing seroreactivity and thus decreasing mosquito biting on participants from immediately before to immediately after the trial.

Outcome measures

Outcome measures
Measure	Single MDA n=95 Participants Single mass drug administration of ivermectin (150 µg/kg) + albendazole (400 mg) performed after the start of the rainy season as part of public health efforts to eliminate lymphatic filariasis. Ivermectin Albendazole	Repeated MDA n=126 Participants Same as Active Comparator, but then followed by five more mass drug administrations of ivermectin only (150 µg/kg) every three weeks thereafter. Ivermectin Albendazole
Entomological Indicator of Parasite Transmission	-0.057 change in IgG ELISA optical density Interval -0.096 to -0.017	-0.124 change in IgG ELISA optical density Interval -0.161 to -0.088

SECONDARY outcome

Timeframe: Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm

Population: Molecular genotyping was performed on blood samples from 132 enrolled cohort children who were selected using a random sequence generator. Genotyping was successful on blood spots corresponding to 153 malaria episodes, which allowed us to calculate the mFOI over the trial from 76 enrolled children from the cohort.

Examination of new P. falciparum clones acquired from the beginning to the end of the intervention (molecular force of infection; mFOI) per child. Molecular genotyping used capillary blood taken at the time of diagnosis of each positive malaria episode and consisted of nPCR of the msp2 gene. We calculated the multiplicity of infection (MOI) per malaria episode, and then calculated the molecular force of infection (mFOI) associated with malaria episodes per child (over course of the trial)

Outcome measures

Outcome measures
Measure	Single MDA n=38 Participants Single mass drug administration of ivermectin (150 µg/kg) + albendazole (400 mg) performed after the start of the rainy season as part of public health efforts to eliminate lymphatic filariasis. Ivermectin Albendazole	Repeated MDA n=38 Participants Same as Active Comparator, but then followed by five more mass drug administrations of ivermectin only (150 µg/kg) every three weeks thereafter. Ivermectin Albendazole
Molecular Force of P. Falciparum Infection	4 new P. faliciparum infections per child Interval 2.0 to 7.0	3 new P. faliciparum infections per child Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: Approximately 20 weeks, from before the start of the first MDA to 4 weeks following the last MDA in the Experimental arm

Population: This outcome was only measured in older enrolled children between 6-10 years of age, who were not in our primary outcome cohort, and who were eligible to be treated with ivermectin due to their height \>90 cm (232 of 2712 participants).

Prevalence of soil transmitted helminth infections in children between 6-10 years old from the beginning to the end of the intervention

Outcome measures

Outcome measures
Measure	Single MDA n=122 Participants Single mass drug administration of ivermectin (150 µg/kg) + albendazole (400 mg) performed after the start of the rainy season as part of public health efforts to eliminate lymphatic filariasis. Ivermectin Albendazole	Repeated MDA n=110 Participants Same as Active Comparator, but then followed by five more mass drug administrations of ivermectin only (150 µg/kg) every three weeks thereafter. Ivermectin Albendazole
Number of 6-10 Year Old Participants With Soil Transmitted Helminths (STH)	3 participants	0 participants

SECONDARY outcome

Timeframe: 6 sampling periods over 18 weeks, starting in week 2 following the first MDA, and sampling every 3 weeks thereafter until week 17 of the treatment phase.

Population: The mean EIR was calculated across the 6 sampling periods in the 8 study villages (4 villages in each arm). EIR was calculated from the number of mosquitoes captured in select houses and the number of enrolled participants who lived in each sampled house (324/1265 in single MDA arm, and 271/1447 in repeated MDA arm).

The entomological inoculation rate (EIR per week per person) is the measure of the human biting rate per person per week, multiplied by the sporozoite rate (in biting mosquitoes) per week, an estimated from sampling mosquitoes from 8 households located in the center of each study village. The EIR was calculated for each of the 6 sampling weeks of the treatment phase.

Outcome measures

Outcome measures
Measure	Single MDA n=324 Participants Single mass drug administration of ivermectin (150 µg/kg) + albendazole (400 mg) performed after the start of the rainy season as part of public health efforts to eliminate lymphatic filariasis. Ivermectin Albendazole	Repeated MDA n=271 Participants Same as Active Comparator, but then followed by five more mass drug administrations of ivermectin only (150 µg/kg) every three weeks thereafter. Ivermectin Albendazole
Entomological Inoculation Rate	0.2069 infectious bites per person per week Standard Deviation 0.2376	0.1972 infectious bites per person per week Standard Deviation 0.2084

Adverse Events

Single MDA

Serious events: 10 serious events

Other events: 14 other events

Deaths: 5 deaths

Repeated MDA

Serious events: 19 serious events

Other events: 26 other events

Deaths: 15 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Brian D. Foy, Professor

Colorado State University

Phone: 970-491-3470

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Single MDA n=1265 participants at risk Single mass drug administration of ivermectin (150 µg/kg) + albendazole (400 mg) performed after the start of the rainy season as part of public health efforts to eliminate lymphatic filariasis. Ivermectin Albendazole	Repeated MDA n=1447 participants at risk Same as Active Comparator, but then followed by five more mass drug administrations of ivermectin only (150 µg/kg) every three weeks thereafter. Ivermectin Albendazole
Infections and infestations moderate to severe malaria	0.55% 7/1265 • Number of events 7 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.48% 7/1447 • Number of events 7 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Infections and infestations neonatal infection	0.08% 1/1265 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.00% 0/1447 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Cardiac disorders untreated decompensated hypertensive heart failure	0.08% 1/1265 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.00% 0/1447 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Infections and infestations fever, vomiting, anorexia	0.08% 1/1265 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.00% 0/1447 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Gastrointestinal disorders acute intestinal obstruction	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Hepatobiliary disorders liver disease: ascites + bulky edema of the lower limbs.	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Hepatobiliary disorders liver cancer, cirrhosis of the liver	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Gastrointestinal disorders abdominal pain, loose stool, vomiting	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Respiratory, thoracic and mediastinal disorders dyspnea	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Infections and infestations fever, anemia, cachexia	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Infections and infestations severe sepsis	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Investigations unspecified sudden death in the early morning	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Gastrointestinal disorders vomiting, hematemesis, bloody stool, cardiovascular shock	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Gastrointestinal disorders Abdominal bloating, fecal matter obstruction, anuria, refusal to breastfeed	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Infections and infestations fever and chills; suspected typhoid fever	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Injury, poisoning and procedural complications snakebite envenomation	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Respiratory, thoracic and mediastinal disorders Infectious pneumopathy	0.08% 1/1265 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.00% 0/1447 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)

Measure	Single MDA n=1265 participants at risk Single mass drug administration of ivermectin (150 µg/kg) + albendazole (400 mg) performed after the start of the rainy season as part of public health efforts to eliminate lymphatic filariasis. Ivermectin Albendazole	Repeated MDA n=1447 participants at risk Same as Active Comparator, but then followed by five more mass drug administrations of ivermectin only (150 µg/kg) every three weeks thereafter. Ivermectin Albendazole
Infections and infestations malaria	0.16% 2/1265 • Number of events 2 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.14% 2/1447 • Number of events 2 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Infections and infestations acute malnutrition	0.16% 2/1265 • Number of events 2 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.35% 5/1447 • Number of events 5 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Infections and infestations fever	0.08% 1/1265 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.00% 0/1447 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Infections and infestations diarrhea	0.08% 1/1265 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.00% 0/1447 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Injury, poisoning and procedural complications unspecified injury	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Infections and infestations stage 3 tooth decay with local tumefaction	0.08% 1/1265 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.00% 0/1447 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Eye disorders Bilateral palpebral edema	0.08% 1/1265 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.00% 0/1447 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
General disorders Tremor, palpitations, arthralgia	0.08% 1/1265 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.00% 0/1447 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Ear and labyrinth disorders Perforated bilaterally suppurated otitis	0.08% 1/1265 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.00% 0/1447 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Immune system disorders pruritis	0.08% 1/1265 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.14% 2/1447 • Number of events 2 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Injury, poisoning and procedural complications snakebite envenomation	0.08% 1/1265 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.00% 0/1447 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Skin and subcutaneous tissue disorders intercostal zoster from immune system depression	0.08% 1/1265 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.00% 0/1447 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Ear and labyrinth disorders acute otitis media	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Gastrointestinal disorders febrile diarrhea	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Injury, poisoning and procedural complications first degree burn over 80% of lower right limb	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Ear and labyrinth disorders suppurative otitis	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Pregnancy, puerperium and perinatal conditions Involuntary abortion at two months of pregnancy	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Injury, poisoning and procedural complications road accident	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Skin and subcutaneous tissue disorders Chronic wound in the left ankle	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
General disorders	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Pregnancy, puerperium and perinatal conditions Postpartum pelvic pain	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Gastrointestinal disorders Abdominal pain, loose stool, vomiting	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Infections and infestations headache and chills; suspected infectious origin	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Musculoskeletal and connective tissue disorders Swelling of the feet, hyperthermia and chills	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Gastrointestinal disorders vomiting	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.21% 3/1447 • Number of events 3 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)
Infections and infestations fever and chills; suspected typhoid	0.00% 0/1265 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)	0.07% 1/1447 • Number of events 1 Adverse events were measured from the total population of enrolled participants in the eight study villages (n=2712), and most of these participants received the study intervention (ivermectin MDA)