Comparison · NCT00797797-sae
Milnacipran Added vs No Treatment Added: 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. Milnacipran Added vs No Treatment Added: serious adverse events. Trial comparisons, record NCT00797797-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00797797-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 | 0.0272 | 0.0117 | 0.062 | wilson | |
| Risk in group 2 | 0.0337 | 0.0155 | 0.0716 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00653 | -0.0475 | 0.0328 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.806 | 0.251 | 2.59 | log | |
| Odds ratio, group 1 over group 2 | 0.801 | 0.24 | 2.67 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Milnacipran Added than on No Treatment Added | 153 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: no treatment.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Milnacipran Added | Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period | 5 | 184 | EG001 |
| Group 2 | No Treatment Added | No treatment added for 11 weeks of randomized treatment period | 6 | 178 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Treatment emergent adverse events, defined as adverse events which occurred or worsened after starting randomized study drug, were collected from December 2008 to November 2009.
Source ClinicalTrials.gov
Trial
- Title
- Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia
- NCT number
- NCT00797797
- Phases
- PHASE3
- Conditions
- Fibromyalgia
- Interventions
- No Treatment Added, Milnacipran Added
- Lead sponsor
- Forest Laboratories
- Results first posted
- 2011-02-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00797797?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
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