Comparison · NCT01091662-sae
ESL1200 mg vs ESL 1600 mg: 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. ESL1200 mg vs ESL 1600 mg: serious adverse events. Trial comparisons, record NCT01091662-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01091662-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 | 0.0172 | 0.00305 | 0.0914 | wilson | |
| Risk in group 2 | 0.0702 | 0.036 | 0.132 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0529 | -0.117 | 0.0287 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.246 | 0.0315 | 1.92 | log | |
| Odds ratio, group 1 over group 2 | 0.232 | 0.0284 | 1.91 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on ESL1200 mg than on ESL 1600 mg | 18.9 | 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 | ESL1200 mg | Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18. | 1 | 58 | EG000 |
| Group 2 | ESL 1600 mg | Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18. | 8 | 114 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 18 week double-blind treatment period
Source ClinicalTrials.gov
Trial
- Title
- Safety & Efficacy of Eslicarbazepine Monotherapy in Sub.w/Partial Epilepsy Not Well Controlled by Current Antiepileptic
- NCT number
- NCT01091662
- Phases
- PHASE3
- Conditions
- Epilepsy
- Interventions
- Eslicarbazepine acetate 1600 mg, Eslicarbazepine acetate 1200 mg
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Results first posted
- 2015-12-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01091662?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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