Comparison · NCT01921205-sae
Lacosamide 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 vs Placebo: serious adverse events. Trial comparisons, record NCT01921205-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01921205-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 | 0.0643 | 0.0363 | 0.112 | wilson | |
| Risk in group 2 | 0.0756 | 0.0447 | 0.125 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0113 | -0.0681 | 0.0451 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.851 | 0.392 | 1.85 | log | |
| Odds ratio, group 1 over group 2 | 0.841 | 0.366 | 1.93 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Lacosamide than on Placebo | 88.9 | 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 | This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing \<30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing \>=30kg to \<50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing \>=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study. | 11 | 171 | EG001 |
| Group 2 | Placebo | This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets. | 13 | 172 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
Source ClinicalTrials.gov
Trial
- Title
- Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures
- NCT number
- NCT01921205
- Phases
- PHASE3
- Conditions
- Epilepsy
- Interventions
- Lacosamide, Placebo
- Lead sponsor
- UCB Pharma
- Results first posted
- 2018-03-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01921205?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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