Comparison · NCT01243177-ac550c83
Lacosamide vs Carbamazepine-Controlled Release (CBZ-CR): Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks)
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): Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks). Trial comparisons, record NCT01243177-ac550c83. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01243177-ac550c83
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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 | 0.0721 | 0.0515 | 0.1 | wilson | |
| Risk in group 2 | 0.0973 | 0.073 | 0.128 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0252 | -0.0626 | 0.0118 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.741 | 0.478 | 1.15 | log | |
| Odds ratio, group 1 over group 2 | 0.721 | 0.447 | 1.16 | log | |
| Number needed to treat, for one fewer participant with the outcome on Lacosamide than on Carbamazepine-Controlled Release (CBZ-CR) | 39.7 | 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 | 32 | 444 | OG000 |
| 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 | 43 | 442 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks)
- Description
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.~A Serious Adverse Event must meet 1 or more predefined criteria like death, life-threatening, etc. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.
- Time frame
- Duration of the Treatment Phase (up to 113 weeks)
- Population
- Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
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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