Comparison · NCT00538863-sae
Fentanyl Sublingual Spray Titration vs Fentanyl Sublingual Spray Maintenance: 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 Sublingual Spray Titration vs Fentanyl Sublingual Spray Maintenance: serious adverse events. Trial comparisons, record NCT00538863-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00538863-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 | 0.144 | 0.104 | 0.195 | wilson | |
| Risk in group 2 | 0.662 | 0.603 | 0.716 | wilson | |
| Risk difference, group 1 minus group 2 | -0.518 | -0.585 | -0.44 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.218 | 0.157 | 0.302 | log | |
| Odds ratio, group 1 over group 2 | 0.0861 | 0.055 | 0.135 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Fentanyl Sublingual Spray Titration than on Fentanyl Sublingual Spray Maintenance | 1.93 | 1.71 | 2.27 | 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 | Fentanyl Sublingual Spray Titration | Patients received fentanyl sublingual spray to treat up to a maximum of 4 breakthrough pain episodes per day with a minimum separation of 4 hours between treatments. Patients started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 26 days was reached. | 33 | 229 | EG000 |
| Group 2 | Fentanyl Sublingual Spray Maintenance | Patients received fentanyl sublingual spray up to a maximum of 4 times per day with a minimum separation of 4 hours between treatments for 90 days. Patients received a dose of 100 to 1600 µg determined in a previous study (INS-05-001, NCT00538850) or in the open-label dose titration period of the current study. The dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects. | 178 | 269 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Source ClinicalTrials.gov
Trial
- Title
- Long-term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain
- NCT number
- NCT00538863
- Phases
- PHASE3
- Conditions
- Cancer, Pain
- Interventions
- Fentanyl sublingual spray
- Lead sponsor
- INSYS Therapeutics Inc
- Results first posted
- 2013-10-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00538863?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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