Comparison · NCT01551758-ef6a04a5
FF/VI 100 mcg/25 mcg vs Usual Care: Number of Participants With Serious Adverse Events
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/VI 100 mcg/25 mcg vs Usual Care: Number of Participants With Serious Adverse Events. Trial comparisons, record NCT01551758-ef6a04a5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01551758-ef6a04a5
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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 | 0.289 | 0.266 | 0.314 | wilson | |
| Risk in group 2 | 0.273 | 0.25 | 0.297 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0164 | -0.0169 | 0.0497 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.06 | 0.942 | 1.19 | log | |
| Odds ratio, group 1 over group 2 | 1.08 | 0.92 | 1.28 | log | |
| Number needed to treat, for one more participant with the outcome on FF/VI 100 mcg/25 mcg than on Usual Care | 60.9 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: usual care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | FF/VI 100 mcg/25 mcg | Participants were prescribed one inhalation of fluticasone furoate /vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally. | 404 | 1,396 | OG001 |
| Group 2 | Usual Care | Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months | 383 | 1,403 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Serious Adverse Events
- Description
SAEs assessed included medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a significant medical event in the investigator's judgment, or is an event of possible drug-induced liver injury with hyperbilirubinaemia. SAEs were includes if the onset date was on or after the treatment start date and on or before the treatment stop date. However, the window for an SAE of pneumonia was longer and included 28 days post study treatment stop date.
- Time frame
- Up to 56 weeks
- Population
- ITT Population
Source ClinicalTrials.gov
Trial
- Title
- A Randomised Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD)
- NCT number
- NCT01551758
- Phases
- PHASE3
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- FF/VI, Existing Maintenance Therapy
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2017-03-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01551758?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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