Comparison · NCT04777331-0b04be38
DBT Period: Prasinezumab vs DBT Period: Placebo: DBT Period: Number of Participants With Infusion Related Reactions (IRRs)
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 Infusion Related Reactions (IRRs). Trial comparisons, record NCT04777331-0b04be38. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04777331-0b04be38
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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 | 0.11 | 0.0787 | 0.151 | wilson | |
| Risk in group 2 | 0.128 | 0.094 | 0.171 | wilson | |
| Risk difference, group 1 minus group 2 | -0.018 | -0.0712 | 0.035 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.859 | 0.551 | 1.34 | log | |
| Odds ratio, group 1 over group 2 | 0.842 | 0.509 | 1.39 | log | |
| Number needed to treat, for one fewer participant with the outcome on DBT Period: Prasinezumab than on DBT Period: Placebo | 55.6 | 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 | DBT Period: Prasinezumab | Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks. | 32 | 292 | OG001 |
| Group 2 | DBT Period: Placebo | Participants received prasinezumab matching placebo as an IV infusion, Q4W up to at least 76 weeks. | 37 | 290 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- DBT Period: Number of Participants With Infusion Related Reactions (IRRs)
- Description
IRRs were defined as any signs and symptoms (AEs) occurring during infusion and/or within 24 hours administration after the end of infusion and were considered related to study treatment by the investigator. Symptoms include flushing, rash, respiratory difficulty, hypotension, tachycardia.
- 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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