Comparison · NCT00567255-sae
NB32/48 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
Cite this record
ConductScience Library. NB32/48 vs Placebo: serious adverse events. Trial comparisons, record NCT00567255-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00567255-sae
On this page
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 | 0.0212 | 0.0139 | 0.0321 | wilson | |
| Risk in group 2 | 0.0142 | 0.00691 | 0.0291 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00694 | -0.00959 | 0.0201 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.49 | 0.637 | 3.48 | log | |
| Odds ratio, group 1 over group 2 | 1.5 | 0.633 | 3.55 | log | |
| Number needed to harm, for one more participant with a serious adverse event on NB32/48 than on Placebo | 144 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | NB32/48 | Naltrexone SR 32 mg/bupropion SR 360 mg/day or naltrexone SR 48 mg/bupropion SR 360 mg/day~Beginning at Week 28 through Week 44, NB32-treated subjects who failed to achieve or maintain at least 5% body weight loss from baseline were re-randomized (1:1 ratio) to continue NB32 or begin treatment with a higher dose of naltrexone SR - naltrexone SR 48 mg/bupropion SR 360 mg (referred to as NB48) (daily dose of bupropion SR was 360 mg for NB32 and NB48).~NB32/48 group includes all participants in the safety analysis set randomized to NB32 at baseline, regardless of re-randomization status. | 21 | 992 | EG000 |
| Group 2 | Placebo | Placebo | 7 | 492 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline, 56 weeks
Source ClinicalTrials.gov
Trial
- Title
- A Safety and Efficacy Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects
- NCT number
- NCT00567255
- Phases
- PHASE3
- Conditions
- Obesity, Overweight
- Interventions
- Naltrexone SR 32 mg/bupropion SR 360 mg/day, Placebo, Ancillary therapy
- Lead sponsor
- Orexigen Therapeutics, Inc
- Results first posted
- 2014-11-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00567255?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT00567255-sae