Comparison · NCT00350103-sae
Lacosamide Pooled FT and ST 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. Lacosamide Pooled FT and ST vs Placebo: serious adverse events. Trial comparisons, record NCT00350103-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00350103-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 | 0.0757 | 0.0529 | 0.107 | wilson | |
| Risk in group 2 | 0.0782 | 0.0472 | 0.127 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00254 | -0.0564 | 0.0417 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.968 | 0.522 | 1.79 | log | |
| Odds ratio, group 1 over group 2 | 0.965 | 0.495 | 1.88 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Lacosamide Pooled FT and ST than on Placebo | 394 | 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 | Lacosamide Pooled FT and ST | Subjects received LCM as Fast Titration (FT) or Standard Titration (ST). | 28 | 370 | EG001 |
| Group 2 | Placebo | Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase. | 14 | 179 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected from baseline until the end of the trial (up to Week 18)
Source ClinicalTrials.gov
Trial
- Title
- A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy
- NCT number
- NCT00350103
- Phases
- PHASE3
- Conditions
- Painful Diabetic Neuropathy
- Interventions
- SPM 929, Placebo
- Lead sponsor
- UCB Pharma
- Results first posted
- 2024-03-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00350103?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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GET https://conductscience.org/api/comparisons/v1/NCT00350103-sae