Comparison · NCT01908842-sae
BNX Tablets, Then OL BNX Tablets, Then BNX Film vs Buprenorphine, Then OL BNX Film, Then BNX Tablets: 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. BNX Tablets, Then OL BNX Tablets, Then BNX Film vs Buprenorphine, Then OL BNX Film, Then BNX Tablets: serious adverse events. Trial comparisons, record NCT01908842-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01908842-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 | 0.00783 | 0.00267 | 0.0228 | wilson | |
| Risk in group 2 | 0.00267 | 0.000471 | 0.0149 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00517 | -0.00816 | 0.0203 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.94 | 0.307 | 28.1 | log | |
| Odds ratio, group 1 over group 2 | 2.95 | 0.306 | 28.5 | log | |
| Number needed to harm, for one more participant with a serious adverse event on BNX Tablets, Then OL BNX Tablets, Then BNX Film than on Buprenorphine, Then OL BNX Film, Then BNX Tablets | 194 | 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 | BNX Tablets, Then OL BNX Tablets, Then BNX Film | Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit | 3 | 383 | EG000 |
| Group 2 | Buprenorphine, Then OL BNX Film, Then BNX Tablets | Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit | 1 | 375 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Monitoring for adverse events was conducted from baseline through Day 22.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults
- NCT number
- NCT01908842
- Phases
- PHASE3
- Conditions
- Opioid Dependence, on Agonist Therapy
- Interventions
- BNX sublingual tablets, BNX sublingual film, Buprenorphine
- Lead sponsor
- Orexo AB
- Results first posted
- 2015-05-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01908842?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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