Comparison · NCT01145417-sae
Pregabalin-Pregabalin vs Placebo-Pregabalin: 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-Pregabalin vs Placebo-Pregabalin: serious adverse events. Trial comparisons, record NCT01145417-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01145417-sae
On this page
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 | 0.037 | 0.0145 | 0.0914 | wilson | |
| Risk in group 2 | 0.0275 | 0.0094 | 0.0778 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00951 | -0.0456 | 0.0668 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.35 | 0.308 | 5.87 | log | |
| Odds ratio, group 1 over group 2 | 1.36 | 0.297 | 6.22 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Pregabalin-Pregabalin than on Placebo-Pregabalin | 105 | 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 | Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period. | 4 | 108 | EG000 |
| Group 2 | Placebo-Pregabalin | Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period. | 3 | 109 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Pregabalin Trial In HIV Neuropathic Pain
- NCT number
- NCT01145417
- Phases
- PHASE3
- Conditions
- HIV-1 Infection, Neuropathic Pain
- Interventions
- pregabalin (Lyrica)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Results first posted
- 2013-06-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01145417?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01145417-sae