Comparison · NCT03103919-1ad870ad
Rotigotine + Standard Care SS vs Rotigotine + Standard Care + Kinesia-360™ Wearable Device SS: Number of Subjects With Any Adverse Events During the Course of the Study
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 SS vs Rotigotine + Standard Care + Kinesia-360™ Wearable Device SS: Number of Subjects With Any Adverse Events During the Course of the Study. Trial comparisons, record NCT03103919-1ad870ad. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03103919-1ad870ad
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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 | 0.45 | 0.258 | 0.658 | wilson | |
| Risk in group 2 | 0.579 | 0.363 | 0.769 | wilson | |
| Risk difference, group 1 minus group 2 | -0.129 | -0.399 | 0.171 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.777 | 0.419 | 1.44 | log | |
| Odds ratio, group 1 over group 2 | 0.595 | 0.168 | 2.11 | log | |
| Number needed to treat, for one fewer participant with the outcome on Rotigotine + Standard Care SS than on Rotigotine + Standard Care + Kinesia-360™ Wearable Device SS | 7.76 | 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 SS | 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. | 9 | 20 | OG000 |
| Group 2 | Rotigotine + Standard Care + Kinesia-360™ Wearable Device SS | 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. | 11 | 19 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Subjects With Any Adverse Events During the Course of the Study
- Description
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
- Time frame
- Visit 1 (Week 1) to Visit 2 (Week 12)
- Population
- The Safety Set (SS) included all subjects who received at least 1 dose of Neupro.
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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