Comparison · NCT01718483-sae
SPD489 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. SPD489 vs PLACEBO: serious adverse events. Trial comparisons, record NCT01718483-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01718483-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 | 0.0156 | 0.00533 | 0.0449 | wilson | |
| Risk in group 2 | 0.0107 | 0.00294 | 0.0382 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00493 | -0.0244 | 0.0352 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.46 | 0.247 | 8.64 | log | |
| Odds ratio, group 1 over group 2 | 1.47 | 0.243 | 8.89 | log | |
| Number needed to harm, for one more participant with a serious adverse event on SPD489 than on PLACEBO | 203 | 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 | SPD489 | SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached. | 3 | 192 | EG001 |
| Group 2 | PLACEBO | Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks. | 2 | 187 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of study drug up to 3 days after the last dose at up to 12 weeks
Source ClinicalTrials.gov
Trial
- Title
- SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
- NCT number
- NCT01718483
- Phases
- PHASE3
- Conditions
- Binge Eating Disorder
- Interventions
- SPD489 (Lisdexamfetamine dimesylate), Placebo
- Lead sponsor
- Shire
- Results first posted
- 2014-07-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01718483?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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