Comparison · NCT03179631-ab6f6800
Ataluren vs Placebo: DB Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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: DB Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs). Trial comparisons, record NCT03179631-ab6f6800. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03179631-ab6f6800
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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 | 0.853 | 0.795 | 0.897 | wilson | |
| Risk in group 2 | 0.847 | 0.786 | 0.892 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00667 | -0.0675 | 0.0815 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.924 | 1.1 | log | |
| Odds ratio, group 1 over group 2 | 1.05 | 0.591 | 1.88 | log | |
| Number needed to treat, for one more participant with the outcome on Ataluren than on Placebo | 150 | 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 oral suspension 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening each day for 72 weeks in DB treatment period and for an additional 72 weeks in OL treatment period. | 157 | 184 | OG000 |
| Group 2 | Placebo | Participants received placebo matched to ataluren oral suspension for 72 weeks in DB treatment period. After completion of DB treatment period, participants received ataluren oral suspension 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening each day for 72 weeks in OL treatment period. | 149 | 176 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- DB Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- Description
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A TEAE was defined as an AE that occurred or worsened on or after the first dose of study drug and up to 4 weeks after the last dose of double-blind study drug and prior to the first dose of open-label treatment. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
- Time frame
- Baseline up to Week 76
- Population
- The as-treated population included all randomized participants who received study treatment, with treatment assignments designated according to actual treatment received.
Source ClinicalTrials.gov
Trial
- Title
- Long-Term Outcomes of Ataluren in Duchenne Muscular Dystrophy
- NCT number
- NCT03179631
- Phases
- PHASE3
- Conditions
Muscular Dystrophy, Duchenne, Muscular Dystrophies, Muscular Disorders, Atrophic, Muscular Diseases, Musculoskeletal Disease, Neuromuscular Diseases, Nervous System Diseases, Genetic Diseases, X-Linked, Genetic Diseases, Inborn
- Interventions
- Ataluren, PLACEBO
- Lead sponsor
- PTC Therapeutics
- Results first posted
- 2026-03-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03179631?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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