DB Period: Vutrisiran vs DB Period: Placebo: Composite Endpoint of All-Cause Mortality and Recurrent CV Events (CV Hospitalizations and Urgent HF Visits) in the Vutrisiran Monotherapy Subgroup
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.388 | 0.322 | 0.458 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.528 | 0.458 | 0.596 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.14 | -0.234 | -0.0416 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.735 | 0.59 | 0.915 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.567 | 0.38 | 0.846 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on DB Period: Vutrisiran than on DB Period: Placebo | 7.15 | 4.27 | 24 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | DB Period: Vutrisiran | Participants in the DB period received vutrisiran, 25 mg, SC injection, q3M for up to 36 months. | 76 | 196 | OG001 | ClinicalTrials.gov |
| Group 2 | DB Period: Placebo | Participants in the DB period received vutrisiran matching placebo, SC injection, q3M for up to 36 months. | 105 | 199 | OG000 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Composite Endpoint of All-Cause Mortality and Recurrent CV Events (CV Hospitalizations and Urgent HF Visits) in the Vutrisiran Monotherapy Subgroup | ClinicalTrials.gov |
| Description | All-cause mortality and recurrent CV events (CV hospitalizations and urgent HF visits) were compared between treatment groups using a modified Andersen-Gill model with a robust variance. All-cause mortality included heart transplantation and LVAD placement events along with deaths; recurrent CV events included CV hospitalizations and urgent HF visits. The number of participants with at least one CV event or all-cause mortality event have been reported here. No imputation was done for participants who dropped out early for the primary analysis of this composite outcome endpoint. | ClinicalTrials.gov |
| Time frame | Up to Month 36 | ClinicalTrials.gov |
| Population | Vutrisiran Monotherapy Subgroup FAS included all participants who were not on tafamidis at the study baseline in the FAS. FAS included all participants who were randomized and received any amount of study drug (vutrisiran or placebo). | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy | ClinicalTrials.gov |
| NCT number | NCT04153149 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Transthyretin Amyloidosis (ATTR) With Cardiomyopathy | ClinicalTrials.gov |
| Interventions | Vutrisiran, Sterile Normal Saline (0.9% NaCl) | ClinicalTrials.gov |
| Lead sponsor | Alnylam Pharmaceuticals | ClinicalTrials.gov |
| Results first posted | 2025-10-21 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT04153149?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.