Comparison · NCT02292537-sae
Nusinersen vs Sham Procedure: serious adverse events
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. Nusinersen vs Sham Procedure: serious adverse events. Trial comparisons, record NCT02292537-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02292537-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 | 0.167 | 0.102 | 0.261 | wilson | |
| Risk in group 2 | 0.286 | 0.172 | 0.436 | wilson | |
| Risk difference, group 1 minus group 2 | -0.119 | -0.282 | 0.0287 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.583 | 0.297 | 1.15 | log | |
| Odds ratio, group 1 over group 2 | 0.5 | 0.207 | 1.21 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Nusinersen than on Sham Procedure | 8.4 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: sham.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Nusinersen | Nusinersen 12 mg solution via intrathecal (IT) injection on Days 1, 29, 85 and 274. | 14 | 84 | EG001 |
| Group 2 | Sham Procedure | Sham comparator on Days 1, 29, 85 and 274. | 12 | 42 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- 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
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02292537?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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