Comparison · NCT00935818-sae
Varenicline and Buproprion SR vs Varenicline and 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. Varenicline and Buproprion SR vs Varenicline and Placebo: serious adverse events. Trial comparisons, record NCT00935818-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00935818-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 | 0.0241 | 0.0111 | 0.0516 | wilson | |
| Risk in group 2 | 0.0233 | 0.0107 | 0.05 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00075 | -0.0289 | 0.031 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.03 | 0.337 | 3.16 | log | |
| Odds ratio, group 1 over group 2 | 1.03 | 0.329 | 3.25 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Varenicline and Buproprion SR than on Varenicline and Placebo | 1,330 | 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 | Varenicline and Buproprion SR | Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks | 6 | 249 | EG000 |
| Group 2 | Varenicline and Placebo | Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks | 6 | 257 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Varenicline and Bupropion for Smoking Cessation
- NCT number
- NCT00935818
- Phases
- PHASE2, PHASE3
- Conditions
- Smoking
- Interventions
- Varenicline, placebo, bupropion SR
- Lead sponsor
- Mayo Clinic
- Results first posted
- 2014-04-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00935818?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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