Comparison · NCT02562066-sae
Amifampridine Phosphate 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. Amifampridine Phosphate vs Placebo: serious adverse events. Trial comparisons, record NCT02562066-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02562066-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 | 0.05 | 0.00888 | 0.236 | wilson | |
| Risk in group 2 | 0.05 | 0.00888 | 0.236 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.191 | 0.191 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.0671 | 14.9 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.0582 | 17.2 | log | |
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Amifampridine Phosphate | Treatment administered to the patient at the time of onset of the AE. Includes patients who received amifampridine phosphate during the run-in period who were not randomized for inclusion in the crossover portion of the study. | 1 | 20 | EG000 |
| Group 2 | Placebo | Treatment administered to the patient at the time of onset of the AE. | 1 | 20 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Serious adverse events (SAEs) were recorded for each patient from the time informed consent was obtained and continues through four weeks after the last dose or at the early discontinuation visit, for a total of approximately 14 weeks. Non-serious AEs were recorded for each patient after informed consent is obtained and the first administration of study drug (on Day 1 of run-in) through the last visit or at the early discontinuation visit, for a total of approximately 10 weeks .
Source ClinicalTrials.gov
Trial
- Title
- Amifampridine Phosphate for the Treatment of Congenital Myasthenic Syndromes
- NCT number
- NCT02562066
- Phases
- PHASE3
- Conditions
- Myasthenic Syndromes, Congenital
- Interventions
- amifampridine phosphate, Placebo
- Lead sponsor
- Catalyst Pharmaceuticals, Inc.
- Results first posted
- 2021-04-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02562066?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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