Comparison · NCT03967054-sae
Ivermectin Mass Drug Administration vs Placebo Mass Administration: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Ivermectin Mass Drug Administration vs Placebo Mass Administration: serious adverse events. Trial comparisons, record NCT03967054-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03967054-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.00365 | 0.00185 | 0.00719 | wilson | |
| Risk in group 2 | 0.0031 | 0.00142 | 0.00676 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000547 | -0.00352 | 0.00446 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.18 | 0.409 | 3.38 | log | |
| Odds ratio, group 1 over group 2 | 1.18 | 0.408 | 3.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Ivermectin Mass Drug Administration than on Placebo Mass Administration | 1,830 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 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. | 8 | 2,191 | EG000 |
| Group 2 | 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 | 6 | 1,933 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 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).
Source ClinicalTrials.gov
Trial
- Title
- Repeat Ivermectin Mass Drug Administrations for MALaria Control II
- NCT number
- NCT03967054
- Phases
- PHASE3
- Conditions
- Malaria
- Interventions
- Ivermectin, Placebo oral tablet
- Lead sponsor
- Brian Foy
- Results first posted
- 2024-01-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03967054?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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