Comparison · NCT01683838-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 NCT01683838-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01683838-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 | 0.0777 | 0.0399 | 0.146 | wilson | |
| Risk in group 2 | 0.09 | 0.0481 | 0.162 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0123 | -0.0939 | 0.0677 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.863 | 0.347 | 2.15 | log | |
| Odds ratio, group 1 over group 2 | 0.851 | 0.315 | 2.3 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Fampridine-SR 50mg/Day than on Placebo | 81.1 | 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) | 8 | 103 | EG000 |
| Group 2 | Placebo | Placebo : Placebo | 9 | 100 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Treatment-emergent adverse events (TEAE) include AEs with date of onset (or worsening) on or after the start of treatment and no more than 14 days after the last dose of investigational drug.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury
- NCT number
- NCT01683838
- Phases
- PHASE3
- Conditions
- Spinal Cord Injury, Muscle Spasticity
- Interventions
- Fampridine-SR, Placebo
- Lead sponsor
- Acorda Therapeutics
- Results first posted
- 2014-02-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01683838?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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