Comparison · NCT01049217-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
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ConductScience Library. Pregabalin vs Placebo: serious adverse events. Trial comparisons, record NCT01049217-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01049217-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 | 0.0383 | 0.0187 | 0.0768 | wilson | |
| Risk in group 2 | 0.0365 | 0.0178 | 0.0733 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00179 | -0.04 | 0.0447 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.375 | 2.93 | log | |
| Odds ratio, group 1 over group 2 | 1.05 | 0.361 | 3.06 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Pregabalin than on Placebo | 558 | 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 | Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period. | 7 | 183 | EG000 |
| Group 2 | Placebo | Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period. | 7 | 192 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy
- NCT number
- NCT01049217
- Phases
- PHASE3
- Conditions
- Neuropathy
- Interventions
- pregabalin, placebo
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Results first posted
- 2013-07-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01049217?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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