Comparison · NCT01509586-sae
PREP (Potentially Reduced Exposure Product) Group vs Cigarette Group: 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. PREP (Potentially Reduced Exposure Product) Group vs Cigarette Group: serious adverse events. Trial comparisons, record NCT01509586-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01509586-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 | 0.00479 | 0.00163 | 0.014 | wilson | |
| Risk in group 2 | 0.00492 | 0.00167 | 0.0144 | wilson | |
| Risk difference, group 1 minus group 2 | -0.000126 | -0.0101 | 0.00963 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.974 | 0.197 | 4.81 | log | |
| Odds ratio, group 1 over group 2 | 0.974 | 0.196 | 4.85 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on PREP (Potentially Reduced Exposure Product) Group than on Cigarette Group | 7,960 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | PREP (Potentially Reduced Exposure Product) Group | Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her. | 3 | 626 | EG000 |
| Group 2 | Cigarette Group | This group will smoke their normal cigarettes as much or as little as they want to. | 3 | 610 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
Source ClinicalTrials.gov
Trial
- Title
- A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco
- NCT number
- NCT01509586
- Phases
- NA
- Conditions
- Smoking, Smoking Cessation
- Interventions
- Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product
- Lead sponsor
- Medical University of South Carolina
- Results first posted
- 2016-08-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01509586?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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