Comparison · NCT01954121-sae
Levetiracetam (Safety Set) vs Carbamazepine-IR (Safety Set): 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. Levetiracetam (Safety Set) vs Carbamazepine-IR (Safety Set): serious adverse events. Trial comparisons, record NCT01954121-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01954121-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 | 0.0413 | 0.0219 | 0.0766 | wilson | |
| Risk in group 2 | 0.0512 | 0.0288 | 0.0893 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00988 | -0.0527 | 0.0319 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.807 | 0.341 | 1.91 | log | |
| Odds ratio, group 1 over group 2 | 0.799 | 0.324 | 1.97 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Levetiracetam (Safety Set) than on Carbamazepine-IR (Safety Set) | 101 | 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 | Levetiracetam (Safety Set) | During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg. | 9 | 218 | EG000 |
| Group 2 | Carbamazepine-IR (Safety Set) | During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg. | 11 | 215 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35).
Source ClinicalTrials.gov
Trial
- Title
- Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures
- NCT number
- NCT01954121
- Phases
- PHASE3
- Conditions
- Epilepsy, Partial Seizures
- Interventions
- Levetiracetam, Carbamazepine
- Lead sponsor
- UCB Pharma SA
- Results first posted
- 2016-08-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01954121?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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