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Comparison · NCT02024555-sae

Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin 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. Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin vs Placebo: serious adverse events. Trial comparisons, record NCT02024555-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02024555-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 10.08160.03220.192wilson
Risk in group 20.06250.02150.168wilson
Risk difference, group 1 minus group 20.0191-0.09770.137newcombe hybrid score
Risk ratio, group 1 over group 21.310.3095.53log
Odds ratio, group 1 over group 21.330.2826.3log
Number needed to harm, for one more participant with a serious adverse event on Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin than on Placebo52.3from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Concomitant Levaquin, Ethambutol, Azithromycin and RifampinLevofloxacin 500mg po QD; Ethambutol 1200mg po QD; Azithromycin 250 mg po QD; Rifampin 600mg po QD or Rifabutin 300mg po QD~Levofloxacin~Ethambutol~Azithromycin~Rifampin449EG000
Group 2Placebo
Riboflavin will be used for rifampin; encapsulated microcrystalline cellulose will be used to replace the levofloxacin, ethambutol and azithromycin.~The pill count will be the same as the comparator regimen.~Placebo: This will serve as a placebo to the antibiotics used in antimycobacterial therapy.
348EG001

Harm

What it counts
Total, serious adverse events
Time frame
24 weeks

Source ClinicalTrials.gov

Trial

Title
Phase II Investigation of Antimycobacterial Therapy on Progressive, Pulmonary Sarcoidosis
NCT number
NCT02024555
Phases
PHASE2
Conditions
Sarcoidosis; Antimycobacterial Therapy
Interventions
Levofloxacin, Ethambutol, Azithromycin, Rifampin, Placebo
Lead sponsor
Vanderbilt University
Results first posted
2020-07-09

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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