Comparison · NCT00493974-sae
Zileuton 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
Cite this record
ConductScience Library. Zileuton vs Placebo: serious adverse events. Trial comparisons, record NCT00493974-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00493974-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 | 0.283 | 0.185 | 0.408 | wilson | |
| Risk in group 2 | 0.339 | 0.231 | 0.466 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0556 | -0.216 | 0.109 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.836 | 0.488 | 1.43 | log | |
| Odds ratio, group 1 over group 2 | 0.771 | 0.354 | 1.68 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Zileuton than on Placebo | 18 | 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 | Zileuton | Zileuton (Zyflo, 600 mg 4 times a day) | 17 | 60 | EG000 |
| Group 2 | Placebo | Matching placebo 4 times a day | 20 | 59 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Participants were followed for adverse events from randomization to the 30 day follow-up visit. AEs that continued past the end of the study period were followed until the Investigator believed it reached a stable clinical endpoint or resolved.
Source ClinicalTrials.gov
Trial
- Title
- Zileuton to Treat Adults With Chronic Obstructive Pulmonary Disease (The LEUKO Study)
- NCT number
- NCT00493974
- Phases
- PHASE3
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Zileuton, Placebo
- Lead sponsor
- University of Minnesota
- Results first posted
- 2010-03-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00493974?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.
For software
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