Comparison · NCT01300819-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 NCT01300819-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01300819-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 | 0.0359 | 0.0183 | 0.0692 | wilson | |
| Risk in group 2 | 0.032 | 0.0125 | 0.0794 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00387 | -0.0467 | 0.0425 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.12 | 0.344 | 3.65 | log | |
| Odds ratio, group 1 over group 2 | 1.13 | 0.332 | 3.82 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Rotigotine than on Placebo | 258 | 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 : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day. | 8 | 223 | EG001 |
| Group 2 | Placebo | Placebo : Placebo patches of 2, 4, 6 \& 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day. | 4 | 125 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
Source ClinicalTrials.gov
Trial
- Title
- Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms
- NCT number
- NCT01300819
- Phases
- PHASE4
- Conditions
- Idiopathic Parkinson's Disease
- Interventions
- Placebo, Rotigotine
- Lead sponsor
- UCB Pharma
- Results first posted
- 2014-05-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01300819?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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