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Comparison · NCT03605862-sae

Nitazoxanide vs Placebo: 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. Nitazoxanide vs Placebo: serious adverse events. Trial comparisons, record NCT03605862-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03605862-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.004590.001790.0117wilson
Risk in group 20.001130.00020.00638wilson
Risk difference, group 1 minus group 20.00346-0.002490.0107newcombe hybrid score
Risk ratio, group 1 over group 24.060.45436.2log
Odds ratio, group 1 over group 24.070.45436.5log
Number needed to harm, for one more participant with a serious adverse event on Nitazoxanide than on Placebo289from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1NitazoxanideTwo Nitazoxanide 300 mg tablets orally twice daily for 5 days4872EG000
Group 2PlaceboTwo placebo tablets orally twice daily for 5 days1884EG001

Harm

What it counts
Total, serious adverse events
Time frame
28 days or until resolution of all adverse events, whichever occurred later.

Source ClinicalTrials.gov

Trial

Title
Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection
NCT number
NCT03605862
Phases
PHASE3
Conditions
Enterovirus, Rhinovirus
Interventions
Nitazoxanide, Placebo
Lead sponsor
Romark Laboratories L.C.
Results first posted
2022-04-14

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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