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Comparison · NCT06597084-sae

Group A vs Group B: serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Group A vs Group B: serious adverse events. Trial comparisons, record NCT06597084-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT06597084-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.1970.1160.313wilson
Risk in group 20.210.1270.326wilson
Risk difference, group 1 minus group 2-0.013-0.1550.13newcombe hybrid score
Risk ratio, group 1 over group 20.9380.4661.89log
Odds ratio, group 1 over group 20.9230.3832.22log
Number needed to treat, for one fewer participant with a serious adverse event on Group A than on Group B77.2from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Group AESL 800 mg~ESL 800 mg: 800 mg ESL tablets for oral administration. In case a patient is unable to swallow the whole tablet, the tablet can be crushed or divided into equal doses at the score line.1261EG000
Group 2Group B
Placebo~Placebo: Placebo tablets for oral administration, matching the test product. In case a patient is unable to swallow the whole tablet, the tablet can be crushed or divided into equal doses at the score line.
1362EG001

Harm

What it counts
Total, serious adverse events
Time frame
The period of monitored/assessed for the collection of AEs started with the first onset or worsening after the first investigational medicinal product (IMP) intake at V1b until 14 days after the last IMP intake, up to 18 months per participant.

Source ClinicalTrials.gov

Trial

Title
Anti-epileptogenic Effects of Eslicarbazepine Acetate
NCT number
NCT06597084
Phases
PHASE2
Conditions
Post Stroke Epilepsy
Interventions
ESL 800 mg, Placebo
Lead sponsor
Bial - Portela C S.A.
Results first posted
2025-05-02

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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