Comparison · NCT04095104-sae
Phentermine & Topiramate 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. Phentermine & Topiramate vs Placebo: serious adverse events. Trial comparisons, record NCT04095104-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04095104-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 | 0.167 | 0.0301 | 0.564 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000278 | 0.39 | wilson | |
| Risk difference, group 1 minus group 2 | 0.167 | -0.247 | 0.564 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on Phentermine & Topiramate than on Placebo | 6 | 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 | Phentermine & Topiramate | Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care. | 1 | 6 | EG000 |
| Group 2 | Placebo | Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care. | 0 | 6 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Source ClinicalTrials.gov
Trial
- Title
- Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds
- NCT number
- NCT04095104
- Phases
- PHASE2
- Conditions
- Obesity, Morbid, Bariatric Surgery, Adolescent, Young Adult, Drug Therapy
- Interventions
- Phentermine, Immediate Release Topiramate, Placebo for Phentermine, Placebo for Immediate Release Topiramate
- Lead sponsor
- University of Colorado, Denver
- Results first posted
- 2025-05-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04095104?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
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