Comparison · NCT01551758-f253f0a6
FF/VI 100 mcg/25 mcg vs Usual Care: Number of Participants With Fatal Serious Adverse Events of Pneumonia
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 Fatal Serious Adverse Events of Pneumonia. Trial comparisons, record NCT01551758-f253f0a6. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01551758-f253f0a6
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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 | 0.00931 | 0.00545 | 0.0159 | wilson | |
| Risk in group 2 | 0.00927 | 0.00542 | 0.0158 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0000465 | -0.00753 | 0.00765 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.468 | 2.16 | log | |
| Odds ratio, group 1 over group 2 | 1.01 | 0.464 | 2.18 | log | |
| Number needed to treat, for one more participant with the outcome on FF/VI 100 mcg/25 mcg than on Usual Care | 21,500 | 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 fuorate /vilaneterol (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. | 13 | 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 | 13 | 1,403 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Fatal Serious Adverse Events of Pneumonia
- Description
All SAEs included in the AE subgroup of special interest of pneumonia were considered as an SAE of pneumonias. A fatal SAE was defined as a SAE with outcome of fatal for study participant. The number of participants with fatal SAEs of pneumonia was assessed over 14 months.
- Time frame
- Upto 58 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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