Comparison · NCT01243177-sae
Lacosamide vs Carbamazepine-Controlled Release (CBZ-CR): 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 Carbamazepine-Controlled Release (CBZ-CR): serious adverse events. Trial comparisons, record NCT01243177-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01243177-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 | 0.0811 | 0.0591 | 0.11 | wilson | |
| Risk in group 2 | 0.104 | 0.0789 | 0.136 | wilson | |
| Risk difference, group 1 minus group 2 | -0.023 | -0.0618 | 0.0155 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.779 | 0.514 | 1.18 | log | |
| Odds ratio, group 1 over group 2 | 0.76 | 0.481 | 1.2 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Lacosamide than on Carbamazepine-Controlled Release (CBZ-CR) | 43.5 | 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 | * Strengths: 50 mg / 100 mg~* Form: tablets~* Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~* Duration: up to 118 weeks | 36 | 444 | EG000 |
| Group 2 | Carbamazepine-Controlled Release (CBZ-CR) | * Strengths: 200 mg~* Form: tablets~* Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~* Duration: up to 118 weeks | 46 | 442 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Source ClinicalTrials.gov
Trial
- Title
- Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older
- NCT number
- NCT01243177
- Phases
- PHASE3
- Conditions
- Epilepsy, Monotherapy
- Interventions
- Lacosamide, Carbamazepine-Controlled Release
- Lead sponsor
- UCB BIOSCIENCES GmbH
- Results first posted
- 2016-02-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01243177?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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