Comparison · NCT02352363-sae
CVT-301 vs Observational Cohort: 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. CVT-301 vs Observational Cohort: serious adverse events. Trial comparisons, record NCT02352363-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02352363-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 | 0.155 | 0.117 | 0.203 | wilson | |
| Risk in group 2 | 0.102 | 0.0608 | 0.167 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0526 | -0.0227 | 0.116 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.51 | 0.843 | 2.72 | log | |
| Odds ratio, group 1 over group 2 | 1.61 | 0.83 | 3.12 | log | |
| Number needed to harm, for one more participant with a serious adverse event on CVT-301 than on Observational Cohort | 19 | 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 | CVT-301 | Capsules of Levodopa Inhalational Powder (LIP) used up to 5 times per day for OFF episodes, for up to 54 weeks duration.~CVT-301 | 42 | 271 | EG000 |
| Group 2 | Observational Cohort | Standard of care. Patients in both the CVT-301 treatment group and the observational cohort will be managed with their standard PD treatment throughout the study.~Observational cohort | 13 | 127 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 12 Months
Source ClinicalTrials.gov
Trial
- Title
- Randomized Safety Study of CVT-301 Compared to an Observational Control Group
- NCT number
- NCT02352363
- Phases
- PHASE3
- Conditions
- Idiopathic Parkinson's Disease
- Interventions
- CVT-301, Observational cohort
- Lead sponsor
- Acorda Therapeutics
- Results first posted
- 2018-07-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02352363?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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