Comparison · NCT00803205-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
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ConductScience Library. Ataluren vs Placebo: serious adverse events. Trial comparisons, record NCT00803205-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00803205-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 | 0.383 | 0.301 | 0.473 | wilson | |
| Risk in group 2 | 0.424 | 0.338 | 0.514 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0404 | -0.162 | 0.0832 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.905 | 0.664 | 1.23 | log | |
| Odds ratio, group 1 over group 2 | 0.845 | 0.503 | 1.42 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Ataluren than on Placebo | 24.8 | 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 | Ataluren | Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks. | 46 | 120 | EG000 |
| Group 2 | Placebo | Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks. | 50 | 118 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to 4 Weeks Post-Treatment (Week 52) or Premature Discontinuation (PD)
Source ClinicalTrials.gov
Trial
- Title
- Study of Ataluren (PTC124™) in Cystic Fibrosis
- NCT number
- NCT00803205
- Phases
- PHASE3
- Conditions
- Cystic Fibrosis
- Interventions
- Ataluren, Placebo
- Lead sponsor
- PTC Therapeutics
- Results first posted
- 2020-05-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00803205?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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