Comparison · NCT01387607-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 NCT01387607-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01387607-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 | 0 | 0.0221 | wilson | |
| Risk in group 2 | 0.0549 | 0.0291 | 0.101 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0549 | -0.101 | -0.021 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with a serious adverse event on Pregabalin than on Placebo | 18.2 | 9.9 | 47.7 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Pregabalin | Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase.~Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. | 0 | 170 | EG000 |
| Group 2 | Placebo | Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.~Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level. | 9 | 164 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline to Follow up (Day 105)
Source ClinicalTrials.gov
Trial
- Title
- A Study For Pregabalin In Patients With Fibromyalgia
- NCT number
- NCT01387607
- Phases
- PHASE3
- Conditions
- Fibromyalgia
- Interventions
- pregabalin, placebo
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Results first posted
- 2018-07-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01387607?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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