Comparison · NCT04777331-52b80763
DBT Period: Prasinezumab vs DBT Period: Placebo: DBT Period: Number of Participants With Adverse Events of Special Interest (AESI)
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. DBT Period: Prasinezumab vs DBT Period: Placebo: DBT Period: Number of Participants With Adverse Events of Special Interest (AESI). Trial comparisons, record NCT04777331-52b80763. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04777331-52b80763
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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 | 0 | 0.013 | wilson | |
| Risk in group 2 | 0 | 0.000000000000000000867 | 0.0131 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0131 | 0.013 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | DBT Period: Prasinezumab | Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks. | 0 | 292 | OG001 |
| Group 2 | DBT Period: Placebo | Participants received prasinezumab matching placebo as an IV infusion, Q4W up to at least 76 weeks. | 0 | 290 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- DBT Period: Number of Participants With Adverse Events of Special Interest (AESI)
- Description
An AE was any untoward medical occurrence in participant administered a pharmaceutical product \& which does not necessarily have to have a causal relationship with treatment. It can therefore be any unfavorable and unintended sign (including abnormal laboratory values/ abnormal clinical test results), symptoms/disease temporally associated with use of pharmaceutical product, whether/not considered related to product. AESIs included potential drug-induced liver injury that include an elevated alanine transaminase (ALT) \& aspartate aminotransferase (AST) in combination with either an elevated bilirubin/clinical jaundice defined by Hy's law and suspected transmission of an infectious agent by study drug.
- Time frame
- From study start to end of DBT period to at least 76 weeks
- Population
SAS included all participants who received at least one dose of study drug, with participants grouped according to treatment received. 3 participants in the prasinezumab arm and 1 participant in the placebo arm were randomized but not treated and 2 participants randomized to placebo arm received 1 dose of prasinezumab and were included in the prasinezumab arm for safety analysis.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease
- NCT number
- NCT04777331
- Phases
- PHASE2
- Conditions
- Parkinsons Disease
- Interventions
- Prasinezumab, Placebo
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2025-12-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04777331?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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