Comparison · NCT01701362-sae
Pregabalin vs Placebo: 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 Placebo: serious adverse events. Trial comparisons, record NCT01701362-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01701362-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 | 0.0073 | 0.002 | 0.0262 | wilson | |
| Risk in group 2 | 0.0264 | 0.0129 | 0.0535 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0191 | -0.0467 | 0.00416 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.276 | 0.0579 | 1.32 | log | |
| Odds ratio, group 1 over group 2 | 0.271 | 0.0558 | 1.32 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Pregabalin than on Placebo | 52.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Pregabalin | Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase. | 2 | 274 | EG000 |
| Group 2 | Placebo | Participants randomized to receive placebo | 7 | 265 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Day -21 to Day 112 (week 16) i.e. from baseline until 1 day post last taper dose.
Source ClinicalTrials.gov
Trial
- Title
- Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain
- NCT number
- NCT01701362
- Phases
- PHASE3
- Conditions
- Neuropathic Pain
- Interventions
- pregabalin, placebo
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Results first posted
- 2017-06-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01701362?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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