Comparison · NCT00458341-sae
Ataluren 4, 4, and 8 mg/kg vs Ataluren 10, 10, and 20 mg/kg: 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 4, 4, and 8 mg/kg vs Ataluren 10, 10, and 20 mg/kg: serious adverse events. Trial comparisons, record NCT00458341-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00458341-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 | 0.0333 | 0.00591 | 0.167 | wilson | |
| Risk in group 2 | 0.0333 | 0.00591 | 0.167 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.136 | 0.136 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.0655 | 15.3 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.0597 | 16.8 | log | |
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Ataluren 4, 4, and 8 mg/kg | Participants received ataluren at 4 milligrams in the morning, 4 mg/kg at midday, and 8 mg/kg in the evening for 14 days, followed by a 14-day follow-up period without treatment. | 1 | 30 | EG000 |
| Group 2 | Ataluren 10, 10, and 20 mg/kg | Participants received ataluren at 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for 14 days, followed by a 14-day follow-up period without treatment. | 1 | 30 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Overall Baseline up to Overall Day 56
Source ClinicalTrials.gov
Trial
- Title
- A Study of Ataluren in Pediatric Participants With Cystic Fibrosis
- NCT number
- NCT00458341
- Phases
- PHASE2
- Conditions
- Cystic Fibrosis
- Interventions
- Ataluren
- Lead sponsor
- PTC Therapeutics
- Results first posted
- 2020-03-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00458341?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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