Comparison · NCT00537238-sae
Pregabalin vs Levetiracetam: 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. Pregabalin vs Levetiracetam: serious adverse events. Trial comparisons, record NCT00537238-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00537238-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 | 0.0945 | 0.0643 | 0.137 | wilson | |
| Risk in group 2 | 0.0941 | 0.0641 | 0.136 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000371 | -0.0514 | 0.0522 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.586 | 1.72 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.554 | 1.82 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Pregabalin than on Levetiracetam | 2,700 | 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 | Pregabalin | Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: \>=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period. | 24 | 254 | EG000 |
| Group 2 | Levetiracetam | Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: \>= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period. | 24 | 255 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Pregabalin Versus Levetiracetam In Partial Seizures
- NCT number
- NCT00537238
- Phases
- PHASE3
- Conditions
- Partial Seizures
- Interventions
- pregabalin, levetiracetam
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Results first posted
- 2013-07-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00537238?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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