Comparison · NCT02312206-sae
NEOD001 (24 mg/kg) + Standard of Care vs Placebo + Standard of Care: 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. NEOD001 (24 mg/kg) + Standard of Care vs Placebo + Standard of Care: serious adverse events. Trial comparisons, record NCT02312206-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02312206-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 | 0.677 | 0.592 | 0.751 | wilson | |
| Risk in group 2 | 0.7 | 0.616 | 0.772 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0231 | -0.134 | 0.0888 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.967 | 0.821 | 1.14 | log | |
| Odds ratio, group 1 over group 2 | 0.898 | 0.531 | 1.52 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on NEOD001 (24 mg/kg) + Standard of Care than on Placebo + Standard of Care | 43.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | NEOD001 (24 mg/kg) + Standard of Care | NEOD001, 24 mg/kg IV every 4 weeks on top of Standard of Care | 88 | 130 | EG000 |
| Group 2 | Placebo + Standard of Care | Placebo 0.9% Saline IV every 4 weeks on top of Standard of Care | 91 | 130 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Initiation of study drug through the last study visit or up to 30 days after last dose, whichever is later
Source ClinicalTrials.gov
Trial
- Title
- The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis
- NCT number
- NCT02312206
- Phases
- PHASE3
- Conditions
- Primary Systemic (AL) Amyloidosis
- Interventions
- NEOD001, Placebo
- Lead sponsor
- Prothena Biosciences Ltd.
- Results first posted
- 2019-05-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02312206?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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