Comparison · NCT00041717-sae
Fampridine-SR 50mg/Day vs Placebo: 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. Fampridine-SR 50mg/Day vs Placebo: serious adverse events. Trial comparisons, record NCT00041717-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00041717-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 | 0.0526 | 0.0243 | 0.11 | wilson | |
| Risk in group 2 | 0.0612 | 0.0284 | 0.127 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00859 | -0.0804 | 0.0576 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.86 | 0.286 | 2.58 | log | |
| Odds ratio, group 1 over group 2 | 0.852 | 0.266 | 2.73 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Fampridine-SR 50mg/Day than on Placebo | 116 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Fampridine-SR 50mg/Day | Fampridine-SR : 25mg bid (twice daily) | 6 | 114 | EG000 |
| Group 2 | Placebo | Placebo : Placebo | 6 | 98 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury
- NCT number
- NCT00041717
- Phases
- PHASE3
- Conditions
- Spinal Cord Injury, Muscle Spasticity
- Interventions
- Fampridine-SR, Placebo
- Lead sponsor
- Acorda Therapeutics
- Results first posted
- 2013-05-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00041717?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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