Comparison · NCT00524030-sae
Pregabalin 150 mg/Day vs Pregabalin 600 mg/Day: 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 150 mg/Day vs Pregabalin 600 mg/Day: serious adverse events. Trial comparisons, record NCT00524030-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00524030-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 | 0.0313 | 0.00554 | 0.157 | wilson | |
| Risk in group 2 | 0.132 | 0.0839 | 0.201 | wilson | |
| Risk difference, group 1 minus group 2 | -0.101 | -0.174 | 0.0344 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.237 | 0.0328 | 1.72 | log | |
| Odds ratio, group 1 over group 2 | 0.213 | 0.0272 | 1.66 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Pregabalin 150 mg/Day than on Pregabalin 600 mg/Day | 9.95 | 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 150 mg/Day | Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug \[AED\] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. | 1 | 32 | EG000 |
| Group 2 | Pregabalin 600 mg/Day | Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20. | 17 | 129 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline to Week 21
Source ClinicalTrials.gov
Trial
- Title
- Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
- NCT number
- NCT00524030
- Phases
- PHASE3
- Conditions
- Epilepsies, Partial
- Interventions
- pregabalin 600 mg/day, pregabalin 150 mg/day
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Results first posted
- 2012-05-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00524030?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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