Comparison · NCT01465997-sae
Lacosamide (SS) vs Carbamazepine-Controlled Release (CBZ-CR) (SS): 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 (SS) vs Carbamazepine-Controlled Release (CBZ-CR) (SS): serious adverse events. Trial comparisons, record NCT01465997-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01465997-sae
On this page
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 | 0.115 | 0.0824 | 0.157 | wilson | |
| Risk in group 2 | 0.0818 | 0.0546 | 0.121 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0329 | -0.0177 | 0.0835 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.4 | 0.837 | 2.35 | log | |
| Odds ratio, group 1 over group 2 | 1.45 | 0.822 | 2.57 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Lacosamide (SS) than on Carbamazepine-Controlled Release (CBZ-CR) (SS) | 30.4 | from the risk difference interval | the interval includes no difference |
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 | Lacosamide (SS) | 50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding. | 32 | 279 | EG000 |
| Group 2 | Carbamazepine-Controlled Release (CBZ-CR) (SS) | 200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding. | 22 | 269 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- During the entire study period, up to 5 years
Source ClinicalTrials.gov
Trial
- Title
- Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
- NCT number
- NCT01465997
- Phases
- PHASE3
- Conditions
- Epilepsy, Monotherapy
- Interventions
- Lacosamide, Carbamazepine-Controlled Release (CBZ-CR)
- Lead sponsor
- UCB BIOSCIENCES GmbH
- Results first posted
- 2017-08-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01465997?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
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01465997-sae