Comparison · NCT02345161-a3bddf2e
FF/UMEC/VI 100/62.5/25 µg vs BUD/FOR 400/12 µg: Number of Participants With an On-treatment Penumonia Event in the Extension Part of the Study
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. FF/UMEC/VI 100/62.5/25 µg vs BUD/FOR 400/12 µg: Number of Participants With an On-treatment Penumonia Event in the Extension Part of the Study. Trial comparisons, record NCT02345161-a3bddf2e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02345161-a3bddf2e
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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 | 0.019 | 0.00743 | 0.0479 | wilson | |
| Risk in group 2 | 0.0182 | 0.00709 | 0.0458 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000866 | -0.0291 | 0.0318 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.265 | 4.13 | log | |
| Odds ratio, group 1 over group 2 | 1.05 | 0.259 | 4.25 | log | |
| Number needed to treat, for one more participant with the outcome on FF/UMEC/VI 100/62.5/25 µg than on BUD/FOR 400/12 µg | 1,150 | 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 | FF/UMEC/VI 100/62.5/25 µg | 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. | 4 | 210 | 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. | 4 | 220 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With an On-treatment Penumonia Event in the Extension Part of the Study
- Description
All suspected pneumonias required confirmation as defined by the presence of new infiltrate(s) on chest x-ray AND at least 2 of the following signs and symptoms: Increased cough, Increased sputum purulence (colour) or production, Auscultatory findings of adventitious sounds , Dyspnea or tachypnea, Fever (oral temperature \> 37.5 °C), Elevated WBC (\>10,000/mm3 or \>15 percent immature forms) orr Hypoxemia (HbO2 saturation \<88 percent or at least 2 percent lower than Baseline value).
- Time frame
- Up to Week 52
- Population
- Extension Population
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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