Comparison · NCT02345161-4218cf4d
FF/UMEC/VI 100/62.5/25 µg vs BUD/FOR 400/12 µg: Number of Participants With at Least One On-treatment Bone Fracture Incident in the Treatment Period
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. FF/UMEC/VI 100/62.5/25 µg vs BUD/FOR 400/12 µg: Number of Participants With at Least One On-treatment Bone Fracture Incident in the Treatment Period. Trial comparisons, record NCT02345161-4218cf4d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02345161-4218cf4d
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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 | 0.00439 | 0.00171 | 0.0112 | wilson | |
| Risk in group 2 | 0.00667 | 0.00306 | 0.0145 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00228 | -0.0105 | 0.00546 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.658 | 0.186 | 2.32 | log | |
| Odds ratio, group 1 over group 2 | 0.656 | 0.185 | 2.33 | log | |
| Number needed to treat, for one fewer participant with the outcome on FF/UMEC/VI 100/62.5/25 µg than on BUD/FOR 400/12 µg | 438 | 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 dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study. | 4 | 911 | 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. | 6 | 899 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With at Least One On-treatment Bone Fracture Incident in the Treatment Period
- Description
- To evaluate the potential for bone systemic corticosteroid effects, the incidence of bone fractures was assessed. It was categorized as an adverse event of special interest.
- Time frame
- Up to Week 24
- Population
- ITT 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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