Comparison · NCT02510014-sae
De Novo Subjects vs Roll-over Subjects: 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. De Novo Subjects vs Roll-over Subjects: serious adverse events. Trial comparisons, record NCT02510014-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02510014-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 | 0.0388 | 0.024 | 0.0621 | wilson | |
| Risk in group 2 | 0.035 | 0.0185 | 0.0652 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00382 | -0.0298 | 0.0324 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.11 | 0.497 | 2.47 | log | |
| Odds ratio, group 1 over group 2 | 1.11 | 0.485 | 2.56 | log | |
| Number needed to harm, for one more participant with a serious adverse event on De Novo Subjects than on Roll-over Subjects | 262 | 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 | De Novo Subjects | Subjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period. | 16 | 412 | EG000 |
| Group 2 | Roll-over Subjects | Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period. | 9 | 257 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 1 to Week 49 for De Novo arm Day 1 to Week 25 for the Roll-over arm
Source ClinicalTrials.gov
Trial
- Title
- Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder
- NCT number
- NCT02510014
- Phases
- PHASE3
- Conditions
- Opioid Use Disorder, Opioid-related Disorders
- Interventions
- SUBOXONE sublingual film, RBP-6000
- Lead sponsor
- Indivior Inc.
- Results first posted
- 2018-03-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02510014?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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