NB32 vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.104 | 0.0953 | 0.113 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0867 | 0.0788 | 0.0954 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.0172 | 0.00499 | 0.0294 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.2 | 1.05 | 1.36 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.22 | 1.06 | 1.41 | log | ClinicalTrials.gov | |
| Number needed to harm, for one more participant with a serious adverse event on NB32 than on Placebo | 58.2 | 34 | 201 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | NB32 | NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools. | 463 | 4,455 | EG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools. | 386 | 4,450 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier). | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study) | ClinicalTrials.gov |
| NCT number | NCT01601704 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Obesity, Overweight | ClinicalTrials.gov |
| Interventions | NB32, PBO, Weight Management Program | ClinicalTrials.gov |
| Lead sponsor | Orexigen Therapeutics, Inc | ClinicalTrials.gov |
| Results first posted | 2017-02-27 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01601704?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.