Comparison · NCT01928758-sae
Reduced Nicotine Content Cigarettes vs Usual Nicotine Content Cigarettes: 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. Reduced Nicotine Content Cigarettes vs Usual Nicotine Content Cigarettes: serious adverse events. Trial comparisons, record NCT01928758-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01928758-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 | 0.0745 | 0.0365 | 0.146 | wilson | |
| Risk in group 2 | 0.106 | 0.0588 | 0.185 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0319 | -0.119 | 0.0538 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.7 | 0.278 | 1.76 | log | |
| Odds ratio, group 1 over group 2 | 0.676 | 0.246 | 1.86 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Reduced Nicotine Content Cigarettes than on Usual Nicotine Content Cigarettes | 31.3 | 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 | Reduced Nicotine Content Cigarettes | The experimental group will smoke cigarettes with gradually Reduced Nicotine Content (11.6, 8.6, 4.0, 1.8, 0.9 and 0.3 mg per cigarette) cigarettes, with each nicotine level smoked for 3 weeks, except the lowest level which continues for 6 weeks~Reduced Nicotine Content Cigarettes: Research cigarettes will have gradually reduced nicotine content | 7 | 94 | EG000 |
| Group 2 | Usual Nicotine Content Cigarettes | Research cigarettes with a nicotine content similar to participant's usual brand of cigarettes (around 11.6mg)~Usual Nicotine Content Cigarettes: Usual Nicotine Content Cigarettes | 10 | 94 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All randomized participants throughout the entire 33 weeks of the trial.
Source ClinicalTrials.gov
Trial
- Title
- Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders
- NCT number
- NCT01928758
- Phases
- NA
- Conditions
- Tobacco Dependence
- Interventions
- Reduced Nicotine Content Cigarettes, Usual Nicotine Content Cigarettes
- Lead sponsor
- Milton S. Hershey Medical Center
- Results first posted
- 2019-02-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01928758?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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