Comparison · NCT02758626-sae
Ataluren 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. Ataluren vs Placebo: serious adverse events. Trial comparisons, record NCT02758626-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02758626-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 | 0.467 | 0.248 | 0.699 | wilson | |
| Risk in group 2 | 0.0714 | 0.0127 | 0.315 | wilson | |
| Risk difference, group 1 minus group 2 | 0.395 | 0.0682 | 0.635 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 6.53 | 0.916 | 46.6 | log | |
| Odds ratio, group 1 over group 2 | 11.4 | 1.17 | 110 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Ataluren than on Placebo | 2.53 | 1.58 | 14.7 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Ataluren | ataluren: Powder formulation | 7 | 15 | EG000 |
| Group 2 | Placebo | Placebo: Powder formulation | 1 | 14 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- up to Year 1
Source ClinicalTrials.gov
Trial
- Title
- Ataluren for Nonsense Mutation in CDKL5 and Dravet Syndrome
- NCT number
- NCT02758626
- Phases
- PHASE2
- Conditions
- Epilepsy
- Interventions
- ataluren, Placebo
- Lead sponsor
- NYU Langone Health
- Results first posted
- 2023-02-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02758626?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.govNone 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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