Comparison · NCT01839656-sae
Nusinersen 6 mg vs Nusinersen 12 mg: 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 6 mg vs Nusinersen 12 mg: serious adverse events. Trial comparisons, record NCT01839656-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01839656-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 | 0.75 | 0.301 | 0.954 | wilson | |
| Risk in group 2 | 0.813 | 0.57 | 0.934 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0625 | -0.528 | 0.255 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.923 | 0.5 | 1.7 | log | |
| Odds ratio, group 1 over group 2 | 0.692 | 0.052 | 9.21 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Nusinersen 6 mg than on Nusinersen 12 mg | 16 | 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 | Nusinersen 6 mg | Participants received nusinersen 6 mg injections as an intrathecal (IT) bolus through a lumbar puncture (LP) on Days 1, 15, and 85. Maintenance doses of 12 mg were given on Days 253, 379, 505, 631, 757, 883, 1009, 1135, and 1261. | 3 | 4 | EG000 |
| Group 2 | Nusinersen 12 mg | Participants aged 21 days to 7 months old with infantile-onset SMA received nusinersen 12 mg injections at regular intervals for up to 45 months. | 13 | 16 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to Day 1359
Source ClinicalTrials.gov
Trial
- Title
- A Study to Assess the Efficacy, Safety and Pharmacokinetics of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy (SMA)
- NCT number
- NCT01839656
- Phases
- PHASE2
- Conditions
- Spinal Muscular Atrophy
- Interventions
- nusinersen
- Lead sponsor
- Biogen
- Results first posted
- 2018-10-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01839656?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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