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Comparison · NCT02292537-deaths

Nusinersen vs Sham Procedure: deaths from any cause

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. Nusinersen vs Sham Procedure: deaths from any cause. Trial comparisons, record NCT02292537-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02292537-deaths

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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 1000.0437wilson
Risk in group 2000.0838wilson
Risk difference, group 1 minus group 20-0.08380.0437newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Group 2 names the comparator: sham.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1NusinersenNusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274.084EG001
Group 2Sham ProcedureSham comparator on Days 1, 29, 85 and 274.042EG000

Harm

What it counts
Total, all-cause mortality
Time frame
From signing of Informed Consent to the end of the Follow-up period (Month 15)

Source ClinicalTrials.gov

Trial

Title
A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Participants With Later-onset Spinal Muscular Atrophy (SMA)
NCT number
NCT02292537
Phases
PHASE3
Conditions
Spinal Muscular Atrophy
Interventions
Nusinersen, Sham procedure
Lead sponsor
Biogen
Results first posted
2018-02-22

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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