Comparison · NCT00951379-sae
Arm I (Pioglitazone Hydrochloride) vs Arm II (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. Arm I (Pioglitazone Hydrochloride) vs Arm II (Placebo): serious adverse events. Trial comparisons, record NCT00951379-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00951379-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 | 0.111 | 0.0385 | 0.281 | wilson | |
| Risk in group 2 | 0.04 | 0.0071 | 0.195 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0711 | -0.1 | 0.244 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.78 | 0.309 | 25 | log | |
| Odds ratio, group 1 over group 2 | 3 | 0.291 | 30.9 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm I (Pioglitazone Hydrochloride) than on Arm II (Placebo) | 14.1 | 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 | Arm I (Pioglitazone Hydrochloride) | Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks | 3 | 27 | EG000 |
| Group 2 | Arm II (Placebo) | Three (3) placebo capsules by mouth once daily for 24 weeks | 1 | 25 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse signs and symptoms recorded at each clinic visit beginning week 4 through week 24 (± 1 week). All adverse events followed according to established standards of care. Overall study period: May 2010 to March 2014.
Source ClinicalTrials.gov
Trial
- Title
- Pioglitazone for Oral Premalignant Lesions
- NCT number
- NCT00951379
- Phases
- PHASE2
- Conditions
- Oral Leukoplakia
- Interventions
- Pioglitazone hydrochloride, placebo, laboratory biomarker analysis
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2016-04-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00951379?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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