Comparison · NCT02193074-sae
Nusinersen vs Control: 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 Control: serious adverse events. Trial comparisons, record NCT02193074-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02193074-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 | 0.763 | 0.659 | 0.842 | wilson | |
| Risk in group 2 | 0.951 | 0.839 | 0.987 | wilson | |
| Risk difference, group 1 minus group 2 | -0.189 | -0.298 | -0.0507 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.802 | 0.696 | 0.923 | log | |
| Odds ratio, group 1 over group 2 | 0.165 | 0.0363 | 0.746 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Nusinersen than on Control | 5.3 | 3.35 | 19.7 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Nusinersen | Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302. | 61 | 80 | EG001 |
| Group 2 | Control | Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302. | 39 | 41 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Screening through Day 394 (± 7 days) or early termination
Source ClinicalTrials.gov
Trial
- Title
- A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy
- NCT number
- NCT02193074
- Phases
- PHASE3
- Conditions
- Spinal Muscular Atrophy
- Interventions
- nusinersen, Sham procedure
- Lead sponsor
- Biogen
- Results first posted
- 2017-07-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02193074?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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