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Comparison · NCT04777331-2fbad496

DBT Period: Prasinezumab vs DBT Period: Placebo: DBT Period: Number of Participants With Treatment Discontinuation Due to AEs

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. DBT Period: Prasinezumab vs DBT Period: Placebo: DBT Period: Number of Participants With Treatment Discontinuation Due to AEs. Trial comparisons, record NCT04777331-2fbad496. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04777331-2fbad496

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.006850.001880.0246wilson
Risk in group 20.01030.003520.03wilson
Risk difference, group 1 minus group 2-0.0035-0.02370.0155newcombe hybrid score
Risk ratio, group 1 over group 20.6620.1113.93log
Odds ratio, group 1 over group 20.660.1093.98log
Number needed to treat, for one fewer participant with the outcome on DBT Period: Prasinezumab than on DBT Period: Placebo286from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1DBT Period: PrasinezumabParticipants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks.2292OG001
Group 2DBT Period: PlaceboParticipants received prasinezumab matching placebo as an IV infusion, Q4W up to at least 76 weeks.3290OG000

Outcome

Type
SECONDARY
Title
DBT Period: Number of Participants With Treatment Discontinuation Due to AEs
Description
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
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

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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