Comparison · NCT03085485-e3f9cd8c
Ivacaftor vs Placebo: Safety of Ivacaftor - Number of Participants With Abnormal ECG (Prolonged QT Intervals)
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. Ivacaftor vs Placebo: Safety of Ivacaftor - Number of Participants With Abnormal ECG (Prolonged QT Intervals). Trial comparisons, record NCT03085485-e3f9cd8c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03085485-e3f9cd8c
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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 | 0.0345 | 0.00611 | 0.172 | wilson | |
| Risk in group 2 | 0.1 | 0.0179 | 0.404 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0655 | -0.371 | 0.0944 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.345 | 0.0237 | 5.01 | log | |
| Odds ratio, group 1 over group 2 | 0.321 | 0.0182 | 5.68 | log | |
| Number needed to treat, for one fewer participant with the outcome on Ivacaftor than on Placebo | 15.3 | 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 | Ivacaftor | Ivacaftor, 150 mg PO every 12 hrs for 84 days~Ivacaftor 150 MG: Ivacaftor is a CFTR potentiator | 1 | 29 | OG000 |
| Group 2 | Placebo | matching placebo~Placebo: placebo pills | 1 | 10 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Safety of Ivacaftor - Number of Participants With Abnormal ECG (Prolonged QT Intervals)
- Description
- Number of participants with abnormal changes in their screening ECGs is another factor that will be used to evaluate the safety of ivacaftor.
- Time frame
- From Screening to Day 98
- Population
Source ClinicalTrials.gov
Trial
- Title
- The Topic Trial - Study to Determine the Safety and Efficacy of Ivacaftor
- NCT number
- NCT03085485
- Phases
- PHASE2
- Conditions
- Chronic Obstructive Pulmonary Disease, Chronic Bronchitis
- Interventions
- Ivacaftor 150 MG, Placebo
- Lead sponsor
- University of Alabama at Birmingham
- Results first posted
- 2023-12-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03085485?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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