Comparison · NCT00463047-sae
Fentanyl Buccal Tablets (FBT) vs Immediate-Release Oxycodone: 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. Fentanyl Buccal Tablets (FBT) vs Immediate-Release Oxycodone: serious adverse events. Trial comparisons, record NCT00463047-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00463047-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 | 0.00356 | 0.000628 | 0.0199 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0133 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00356 | -0.0101 | 0.0199 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on Fentanyl Buccal Tablets (FBT) than on Immediate-Release Oxycodone | 281 | 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 | Fentanyl Buccal Tablets (FBT) | FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients. This group includes all subjects in this study who had taken at least one dose of FBT in the course of the study, including both titration periods and both double-blind treatment periods. 320 subjects were randomized to titrate either FBT or oxycodone. 39 subjects received only oxycodone before discontinuing leaving 281 who received FBT during the study. 36 subjects received only FBT before discontinuing, leaving only 284 who received oxycodone. | 1 | 281 | EG000 |
| Group 2 | Immediate-Release Oxycodone | Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug. This arm represents all subjects who had exposure to at least one dose of immediate-release oxycodone either during the titration periods or double-blind periods. 320 subjects were randomized to titrate either FBT or oxycodone. 39 subjects received only oxycodone before discontinuing leaving 281 who received FBT during the study. 36 subjects received only FBT before discontinuing, leaving only 284 who received oxycodone. | 0 | 284 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were monitored throughout the two titration periods and double-blind treatment periods. Each titration period was 7-10 days in length and each double-blind treatment period was 7-17 days. The average duration of treatment was 24.2 days.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain
- NCT number
- NCT00463047
- Phases
- PHASE3
- Conditions
- Chronic Pain
- Interventions
- Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone
- Lead sponsor
- Cephalon
- Results first posted
- 2010-12-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00463047?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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