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Comparison · NCT00686920-sae

New Rifaximin vs Continuing Rifaximin: 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. New Rifaximin vs Continuing Rifaximin: serious adverse events. Trial comparisons, record NCT00686920-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00686920-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 10.6270.5660.684wilson
Risk in group 20.70.5850.795wilson
Risk difference, group 1 minus group 2-0.073-0.1860.0559newcombe hybrid score
Risk ratio, group 1 over group 20.8960.7481.07log
Odds ratio, group 1 over group 20.720.4071.28log
Number needed to treat, for one fewer participant with a serious adverse event on New Rifaximin than on Continuing Rifaximin13.7from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1New Rifaximin
Participants new to receiving rifaximin were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.
158252EG000
Group 2Continuing Rifaximin
Participants who received rifaximin in the previous rifaximin HE study were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.
4970EG001

Harm

What it counts
Total, serious adverse events
Time frame
Baseline up to Month 36

Source ClinicalTrials.gov

Trial

Title
Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy
NCT number
NCT00686920
Phases
PHASE3
Conditions
Hepatic Encephalopathy
Interventions
Rifaximin
Lead sponsor
Bausch Health Americas, Inc.
Results first posted
2019-08-14

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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