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Comparison · NCT02180659-sae

Buprenorphine Implants + Placebo Tablets vs Buprenorphine Tablets + Placebo Implants: serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Buprenorphine Implants + Placebo Tablets vs Buprenorphine Tablets + Placebo Implants: serious adverse events. Trial comparisons, record NCT02180659-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02180659-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.0230.006330.08wilson
Risk in group 20.03370.01150.0945wilson
Risk difference, group 1 minus group 2-0.0107-0.07370.0504newcombe hybrid score
Risk ratio, group 1 over group 20.6820.1173.98log
Odds ratio, group 1 over group 20.6750.114.14log
Number needed to treat, for one fewer participant with a serious adverse event on Buprenorphine Implants + Placebo Tablets than on Buprenorphine Tablets + Placebo Implants93.3from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Buprenorphine Implants + Placebo TabletsFour 80 mg Probuphine implants + daily SL placebo tablets~Buprenorphine implant~sublingual placebo tablets287EG000
Group 2Buprenorphine Tablets + Placebo ImplantsDaily SL BPN tablets (≤8 mg/daily) + four placebo implants~sublingual buprenorphine tablets~placebo implants389EG001

Harm

What it counts
Total, serious adverse events
Time frame
All AEs were documented and followed from the time the subject signed the ICF until 14 days after the EOT Visit (i.e., implant removal and discontinuation of SL BPN/placebo treatment) which was approximately 28 weeks. Serious adverse events and AEs designated as possibly related to study drug were followed until resolution or stabilization.

Source ClinicalTrials.gov

Trial

Title
A Study of Adult Outpatients With Opioid Dependence Transitioned From a Daily SL Buprenorphine to Probuphine® Subdermal Implants
NCT number
NCT02180659
Phases
PHASE3
Conditions
Opioid Dependence
Interventions
sublingual buprenorphine tablets, Buprenorphine implant, placebo implants, sublingual placebo tablets
Lead sponsor
Titan Pharmaceuticals
Results first posted
2018-12-05

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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