Comparison · NCT02139306-24da7785
Ataluren vs Placebo: Number of Participants With Abnormal Vital Signs Reported as TEAEs
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: Number of Participants With Abnormal Vital Signs Reported as TEAEs. Trial comparisons, record NCT02139306-24da7785. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02139306-24da7785
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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 | 0.00000000000000000173 | 0.0267 | wilson | |
| Risk in group 2 | 0.00719 | 0.00127 | 0.0396 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00719 | -0.0396 | 0.0202 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with the outcome on Ataluren than on Placebo | 139 | 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 as oral powder for suspension at the dosages of 10, 10, and 20-mg/kg at morning, midday and evening, respectively for 48 weeks of treatment duration or until treatment discontinuation. | 0 | 140 | OG000 |
| Group 2 | Placebo | Participants received matching placebo orally at morning, midday and evening for 48 weeks of treatment duration or until treatment discontinuation. | 1 | 139 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Abnormal Vital Signs Reported as TEAEs
- Description
Vital signs included systolic and diastolic blood pressure, pulse rate, pulse oximetry, and body temperature. Participants with abnormal vital signs who required clinical intervention or further investigation (beyond ordering a repeat \[confirmatory\] test) unless they are associated with an already reported clinical event are reported.
- Time frame
- From study drug administration to 4-week post treatment follow-up visit (approximately 52 weeks)
- Population
- The as-treated population included all randomized participants who actually received any study treatment.
Source ClinicalTrials.gov
Trial
- Title
- Study of Ataluren in Nonsense Mutation Cystic Fibrosis (ACT CF)
- NCT number
- NCT02139306
- Phases
- PHASE3
- Conditions
- Cystic Fibrosis
- Interventions
- Ataluren (PTC124®), Placebo
- Lead sponsor
- PTC Therapeutics
- Results first posted
- 2020-05-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02139306?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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