Comparison · NCT00874497-sae
Tetomilast 25 mg 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. Tetomilast 25 mg vs Placebo: serious adverse events. Trial comparisons, record NCT00874497-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00874497-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 | 0.255 | 0.155 | 0.389 | wilson | |
| Risk in group 2 | 0.364 | 0.222 | 0.534 | wilson | |
| Risk difference, group 1 minus group 2 | -0.109 | -0.306 | 0.0862 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.701 | 0.366 | 1.34 | log | |
| Odds ratio, group 1 over group 2 | 0.599 | 0.232 | 1.55 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Tetomilast 25 mg than on Placebo | 9.2 | 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 | Tetomilast 25 mg | Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks. | 13 | 51 | EG000 |
| Group 2 | Placebo | Participants were administered matching placebo for 104 weeks (2 years) | 12 | 33 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were reported from the signing of the informed consent, throughout the 104 week treatment period until the follow-up visit of 14 (+2) days.
Source ClinicalTrials.gov
Trial
- Title
- Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema
- NCT number
- NCT00874497
- Phases
- PHASE2
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- tetomilast, placebo
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Results first posted
- 2017-04-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00874497?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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