Comparison · NCT01569464-sae
Rotigotine 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. Rotigotine vs Placebo: serious adverse events. Trial comparisons, record NCT01569464-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01569464-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 | 0.0198 | 0.00545 | 0.0693 | wilson | |
| Risk in group 2 | 0 | 0.00000000000000000694 | 0.0727 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0198 | -0.0543 | 0.0693 | 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 harm, for one more participant with a serious adverse event on Rotigotine than on Placebo | 50.5 | 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 | Rotigotine | Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance) | 2 | 101 | EG000 |
| Group 2 | Placebo | Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks | 0 | 49 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events were recorded during the course of the RL0003 study, which began in March 2012 and concluded in April 2013.
Source ClinicalTrials.gov
Trial
- Title
- Rotigotine Effect on All-day Functioning and Quality of Life in Subjects With Moderate to Severe Restless Legs Syndrome (RLS)
- NCT number
- NCT01569464
- Phases
- PHASE3
- Conditions
- Restless Legs Syndrome
- Interventions
- Rotigotine, Placebo
- Lead sponsor
- UCB Pharma
- Results first posted
- 2014-08-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01569464?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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