Comparison · NCT00760474-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 NCT00760474-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00760474-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 | 0.0417 | 0.00739 | 0.202 | wilson | |
| Risk in group 2 | 0.04 | 0.0071 | 0.195 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00167 | -0.158 | 0.166 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.069 | 15.7 | log | |
| Odds ratio, group 1 over group 2 | 1.04 | 0.0616 | 17.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Pregabalin than on Placebo | 600 | 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 administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58. | 1 | 24 | EG000 |
| Group 2 | Placebo | Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2. | 1 | 25 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Treatment emergent adverse events (all causalities) were reported from the time of first dose of study treatment up to 28 days after last dose of study treatment.
Source ClinicalTrials.gov
Trial
- Title
- An fMRI Study Of Brain Response In Patients With Fibromyalgia
- NCT number
- NCT00760474
- Phases
- PHASE1
- Conditions
- Fibromyalgia
- Interventions
- Pregabalin, then placebo, Placebo, then pregabalin
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Results first posted
- 2012-04-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00760474?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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