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Comparison · NCT01706198-842a427b

FF/VI vs Usual Care: Time to First SAE of Pneumonia

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/VI vs Usual Care: Time to First SAE of Pneumonia. Trial comparisons, record NCT01706198-842a427b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01706198-842a427b

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.01090.007260.0163wilson
Risk in group 20.007550.004650.0122wilson
Risk difference, group 1 minus group 20.00333-0.002590.00945newcombe hybrid score
Risk ratio, group 1 over group 21.440.7632.72log
Odds ratio, group 1 over group 21.450.7622.74log
Number needed to treat, for one more participant with the outcome on FF/VI than on Usual Care300from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: usual care.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1FF/VIParticipants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.232,114OG001
Group 2Usual Care
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
162,119OG000

Outcome

Type
SECONDARY
Title
Time to First SAE of Pneumonia
Description
An SAE of pneumonia was defined as any SAE in the AESI group of pneumonia. The date of an event for an SAE of pneumonia was the AE onset date. Participants who do not have an SAE of pneumonia during the first 364 days of the treatment period (start date of exposure to min \[end date of exposure + 28 days, date of study discontinuation, start date of exposure + 363\]) were censored. Time to first SAE of pneumonia was measured from the date of randomization (that is, study treatment start date) to the onset date of first SAE of pneumonia. The number of participants with first on-treatment SAE of pneumonia has been presented.
Time frame
Up to Week 52
Population
ITT Population

Source ClinicalTrials.gov

Trial

Title
An Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Asthma
NCT number
NCT01706198
Phases
PHASE3
Conditions
Asthma
Interventions
fluticasone furoate + vilanterol, inhaled corticosteroid with or without a long acting beta2-agonist
Lead sponsor
GlaxoSmithKline
Results first posted
2019-01-24

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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