Comparison · NCT02651584-sae
Group 1: SL BPN/NX Tablets + Placebo SC Injections vs Group 2: CAM2038 SC Injections + SL Placebo 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. Group 1: SL BPN/NX Tablets + Placebo SC Injections vs Group 2: CAM2038 SC Injections + SL Placebo Tablets: serious adverse events. Trial comparisons, record NCT02651584-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02651584-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 | 0.0744 | 0.0463 | 0.117 | wilson | |
| Risk in group 2 | 0.0235 | 0.0101 | 0.0538 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0509 | 0.00963 | 0.096 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.17 | 1.18 | 8.5 | log | |
| Odds ratio, group 1 over group 2 | 3.34 | 1.2 | 9.3 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Group 1: SL BPN/NX Tablets + Placebo SC Injections than on Group 2: CAM2038 SC Injections + SL Placebo Tablets | 19.6 | 10.4 | 104 | 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 | Group 1: SL BPN/NX Tablets + Placebo SC Injections | SL BPN: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day.~CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w). | 16 | 215 | EG000 |
| Group 2 | Group 2: CAM2038 SC Injections + SL Placebo Tablets | CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 and 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection).~CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection).~SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily | 5 | 213 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 31 weeks
Source ClinicalTrials.gov
Trial
- Title
- Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence
- NCT number
- NCT02651584
- Phases
- PHASE3
- Conditions
- Opioid Use Disorders
- Interventions
- CAM2038 SC injection, SL BPN/NX tabs, placebo SC injections, SL placebo tablets
- Lead sponsor
- Braeburn Pharmaceuticals
- Results first posted
- 2019-08-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02651584?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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GET https://conductscience.org/api/comparisons/v1/NCT02651584-sae