Comparison · NCT02462759-178c7e2b
ISIS 396443 Part 1 & 2 vs ISIS 396443 Part 2(Participants on Sham in Part 1): Number of Participants With Plasma Antibodies to ISIS 396443
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. ISIS 396443 Part 1 & 2 vs ISIS 396443 Part 2(Participants on Sham in Part 1): Number of Participants With Plasma Antibodies to ISIS 396443. Trial comparisons, record NCT02462759-178c7e2b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02462759-178c7e2b
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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 | 0.0000000000000000139 | 0.215 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000278 | 0.39 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.39 | 0.215 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: sham.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | ISIS 396443 Part 1 & 2 | Participants who received single dose of ISIS 396443 on Day 1, 15, 29, 64, 183 and 302 in Part 1 of the study and then received single dose of ISIS 396443 on Day 1, 120, 239, 358, 477, 596 and 715 in Part 2 of the study. | 0 | 14 | OG001 |
| Group 2 | ISIS 396443 Part 2(Participants on Sham in Part 1) | Participants who received single dose of ISIS 396443 on Day 1, 15, 29, 64, 183, 302, 421, 540, 659 and 778 in Part 2. | 0 | 6 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Plasma Antibodies to ISIS 396443
- Description
- Time frame
- Part 2: Baseline to Day 596
- Population
- The safety population included all participants who were randomized and received at least 1 dose of study treatment or sham procedure.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Assess the Safety and Tolerability of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA).
- NCT number
- NCT02462759
- Phases
- PHASE2
- Conditions
- Spinal Muscular Atrophy
- Interventions
- Nusinersen, Sham Procedure
- Lead sponsor
- Biogen
- Results first posted
- 2020-01-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02462759?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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