Comparison · NCT02345161-ced8775d
Overall Study Arm vs BUD/FOR 400/12 µg: Number of Participants With Any Abnormal Holter Electrocardiogram (ECG) Finding at Week 24
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. Overall Study Arm vs BUD/FOR 400/12 µg: Number of Participants With Any Abnormal Holter Electrocardiogram (ECG) Finding at Week 24. Trial comparisons, record NCT02345161-ced8775d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02345161-ced8775d
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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 | 0.849 | 0.795 | 0.891 | wilson | |
| Risk in group 2 | 0.801 | 0.741 | 0.85 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0481 | -0.025 | 0.121 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.06 | 0.97 | 1.16 | log | |
| Odds ratio, group 1 over group 2 | 1.4 | 0.841 | 2.32 | log | |
| Number needed to treat, for one more participant with the outcome on Overall Study Arm than on BUD/FOR 400/12 µg | 20.8 | from the risk difference interval | the interval includes no difference |
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 | Overall Study Arm | Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA DPI once daily in the morning and placebo via the Turbuhaler BID for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study. | 180 | 212 | OG000 |
| Group 2 | BUD/FOR 400/12 µg | Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study. | 165 | 206 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Any Abnormal Holter Electrocardiogram (ECG) Finding at Week 24
- Description
The 24-hour holter measurements were obtained at Screening and 24 hours prior to Week 24 (Visits 1 and 6). The number of participants with clinically significant change (abnormal) were reported. Holter Monitoring Population: all participants in the ITT Population who had at least one holter monitoring evaluation.
- Time frame
- Up to Week 24
- Population
- Holter Monitoring Population; Only participants with analyzable data at the given time point were analyzed.
Source ClinicalTrials.gov
Trial
- Title
A Comparison Study Between the Fixed Dose Triple Combination of Fluticasone Furoate/ Umeclidinium/ Vilanterol Trifenatate (FF/UMEC/VI) With Budesonide/Formoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- NCT number
- NCT02345161
- Phases
- PHASE3
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Triple FF/UMEC/VI, Placebo to match FF/UMEC/VI, Budesonide/Formoterol, Placebo to match Budesonide/Formoterol combination, Albuterol/salbutamol
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2018-07-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02345161?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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