Comparison · NCT00109772-sae
Lenalidomide vs Placebo to Lenalidomide: 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. Lenalidomide vs Placebo to Lenalidomide: serious adverse events. Trial comparisons, record NCT00109772-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00109772-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 | 0.138 | 0.0807 | 0.226 | wilson | |
| Risk in group 2 | 0.172 | 0.109 | 0.261 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0341 | -0.14 | 0.0742 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.802 | 0.403 | 1.6 | log | |
| Odds ratio, group 1 over group 2 | 0.77 | 0.341 | 1.74 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Lenalidomide than on Placebo to Lenalidomide | 29.3 | 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 | Lenalidomide | 10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure. | 12 | 87 | EG000 |
| Group 2 | Placebo to Lenalidomide | Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure. | 16 | 93 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 1 up to week 158, covering both the double-blind treatment and extension periods.
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Complex Regional Pain Syndrome Type 1
- NCT number
- NCT00109772
- Phases
- PHASE2
- Conditions
- Complex Regional Pain Syndrome, Type I
- Interventions
- lenalidomide, Placebo
- Lead sponsor
- Celgene Corporation
- Results first posted
- 2013-08-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00109772?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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