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Comparison · NCT03946111-sae

Naltrexone/Bupropion vs Placebo: 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. Naltrexone/Bupropion vs Placebo: serious adverse events. Trial comparisons, record NCT03946111-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03946111-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 1000.793wilson
Risk in group 2000.658wilson
Risk difference, group 1 minus group 20-0.6580.793newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Naltrexone/BupropionNaltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.01EG000
Group 2PlaceboPlacebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.02EG001

Harm

What it counts
Total, serious adverse events
Time frame
12 months

Source ClinicalTrials.gov

Trial

Title
Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Medication Change for Non-Responders
NCT number
NCT03946111
Phases
PHASE2, PHASE3
Conditions
Binge-Eating Disorder, Obesity
Interventions
Naltrexone and Bupropion, Placebo
Lead sponsor
Yale University
Results first posted
2025-12-17

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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