Comparison · NCT01551758-dcc26113
FF/VI 100 mcg/25 mcg vs Usual Care: Number of Participants With Serious Adverse Drug Reactions
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 Drug Reactions. Trial comparisons, record NCT01551758-dcc26113. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01551758-dcc26113
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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 | 0.0165 | 0.011 | 0.0246 | wilson | |
| Risk in group 2 | 0.00713 | 0.00388 | 0.0131 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00935 | 0.00127 | 0.0181 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.31 | 1.1 | 4.84 | log | |
| Odds ratio, group 1 over group 2 | 2.33 | 1.11 | 4.92 | log | |
| Number needed to treat, for one more participant with the outcome on FF/VI 100 mcg/25 mcg than on Usual Care | 107 | 55.2 | 788 | from the risk difference interval |
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. | 23 | 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 | 10 | 1,403 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Serious Adverse Drug Reactions
- Description
A serious adverse drug reactions (SADR) is any untoward medical occurrence suspected to be medicinal product-related that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
- Time frame
- Upto 12 months
- 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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