Comparison · NCT00772941-26bd6228
Varenicline - With Concomitant Therapies vs Varenicline - Without Concomitant Therapies: Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Therapies.
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 - With Concomitant Therapies vs Varenicline - Without Concomitant Therapies: Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Therapies. Trial comparisons, record NCT00772941-26bd6228. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00772941-26bd6228
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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 | 0.446 | 0.352 | 0.543 | wilson | |
| Risk in group 2 | 0.212 | 0.198 | 0.226 | wilson | |
| Risk difference, group 1 minus group 2 | 0.234 | 0.14 | 0.332 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.1 | 1.68 | 2.64 | log | |
| Odds ratio, group 1 over group 2 | 2.99 | 2 | 4.47 | log | |
| Number needed to treat, for one more participant with the outcome on Varenicline - With Concomitant Therapies than on Varenicline - Without Concomitant Therapies | 4.28 | 3.01 | 7.16 | from the risk difference interval |
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 - With Concomitant Therapies | Participants receiving concomitant therapies while taking Varenicline according to Japanese Package Insert. | 45 | 101 | OG000 |
| Group 2 | Varenicline - Without Concomitant Therapies | Participants receiving no concomitant therapies while taking Varenicline according to Japanese Package Insert. | 668 | 3,156 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Therapies.
- Description
- Number of participants with Treatment Related Adverse Events of Varenicline to determine whether receiving concomitant therapies is a significant risk factor.
- Time frame
- 24 weeks
- Population
- The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.
Source ClinicalTrials.gov
Trial
- Title
- Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan)
- NCT number
- NCT00772941
- Phases
- Conditions
- Smoking Cessation
- Interventions
- Varenicline
- Lead sponsor
- Pfizer
- Results first posted
- 2014-01-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00772941?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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