Comparison · NCT04542499-sae
Tavapadon 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
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ConductScience Library. Tavapadon vs Placebo: serious adverse events. Trial comparisons, record NCT04542499-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04542499-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 | 0.0675 | 0.0425 | 0.105 | wilson | |
| Risk in group 2 | 0.0549 | 0.033 | 0.09 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0126 | -0.0305 | 0.0563 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.23 | 0.619 | 2.44 | log | |
| Odds ratio, group 1 over group 2 | 1.25 | 0.6 | 2.58 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Tavapadon than on Placebo | 79.6 | 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 | Tavapadon | Participants will receive a tavapadon tablet titrated 5 to 15milligrams (mg) once daily (QD)orally for 27 weeks.~Tavapadon: Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks. | 17 | 252 | EG001 |
| Group 2 | Placebo | Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.~Placebo: Participants will receive placebo matching to tavapadon QD orally for 27 weeks. | 14 | 255 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
Source ClinicalTrials.gov
Trial
- Title
- Flexible-Dose, Adjunctive Therapy Trial in Adults With Parkinson's Disease With Motor Fluctuations (TEMPO-3)
- NCT number
- NCT04542499
- Phases
- PHASE3
- Conditions
- Parkinson Disease
- Interventions
- Tavapadon, Placebo
- Lead sponsor
- AbbVie
- Results first posted
- 2025-03-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04542499?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.govNone 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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