Comparison · NCT00115063-sae
Intensive Medical Intervention vs Access to Weight Loss Informational Website: 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. Intensive Medical Intervention vs Access to Weight Loss Informational Website: serious adverse events. Trial comparisons, record NCT00115063-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00115063-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 | 0.1 | 0.0657 | 0.149 | wilson | |
| Risk in group 2 | 0.0421 | 0.0215 | 0.0809 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0579 | 0.00611 | 0.111 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.38 | 1.07 | 5.26 | log | |
| Odds ratio, group 1 over group 2 | 2.53 | 1.09 | 5.89 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Intensive Medical Intervention than on Access to Weight Loss Informational Website | 17.3 | 8.97 | 164 | 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 | Intensive Medical Intervention | Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach | 20 | 200 | EG000 |
| Group 2 | Access to Weight Loss Informational Website | Access to Weight Loss Informational Website sponsored by the Mayo Clinic | 8 | 190 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Source ClinicalTrials.gov
Trial
- Title
- LOSS- Louisiana Obese Subjects Study
- NCT number
- NCT00115063
- Phases
- PHASE4
- Conditions
- Obesity
- Interventions
- group sessions, sibutramine, orlistat, diethylpropion, Low Calorie Diet, Health One, Intensive Medical Combination Therapy for Obesity, Control Condition
- Lead sponsor
- Pennington Biomedical Research Center
- Results first posted
- 2010-06-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00115063?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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