Comparison · NCT03103919-sae
Rotigotine + Standard Care vs Rotigotine + Standard Care + Kinesia-360™ Wearable Device: 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 + Standard Care vs Rotigotine + Standard Care + Kinesia-360™ Wearable Device: serious adverse events. Trial comparisons, record NCT03103919-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03103919-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 | 0.05 | 0.00888 | 0.236 | wilson | |
| Risk in group 2 | 0.0526 | 0.00935 | 0.246 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00263 | -0.201 | 0.188 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.95 | 0.0639 | 14.1 | log | |
| Odds ratio, group 1 over group 2 | 0.947 | 0.055 | 16.3 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Rotigotine + Standard Care than on Rotigotine + Standard Care + Kinesia-360™ Wearable Device | 380 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Rotigotine + Standard Care | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | 1 | 20 | EG000 |
| Group 2 | Rotigotine + Standard Care + Kinesia-360™ Wearable Device | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. | 1 | 19 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Visit 1 (Day 1) to Visit 2 (Week 12)
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management
- NCT number
- NCT03103919
- Phases
- PHASE4
- Conditions
- Parkinson´s Disease
- Interventions
- Kinesia-ONE™, Kinesia-360™, Rotigotine
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Results first posted
- 2019-02-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03103919?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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