Comparison · NCT01706198-dc8695a6
FF/VI vs Usual Care: Number of Participants With Adverse Drug Reactions (ADRs)
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: Number of Participants With Adverse Drug Reactions (ADRs). Trial comparisons, record NCT01706198-dc8695a6. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01706198-dc8695a6
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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 | 0.154 | 0.139 | 0.17 | wilson | |
| Risk in group 2 | 0.0514 | 0.0428 | 0.0617 | wilson | |
| Risk difference, group 1 minus group 2 | 0.103 | 0.0848 | 0.121 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3 | 2.43 | 3.69 | log | |
| Odds ratio, group 1 over group 2 | 3.36 | 2.68 | 4.21 | log | |
| Number needed to treat, for one more participant with the outcome on FF/VI than on Usual Care | 9.73 | 8.27 | 11.8 | 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 | Participants 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. | 326 | 2,114 | OG001 |
| Group 2 | Usual 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). | 109 | 2,119 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Adverse Drug Reactions (ADRs)
- Description
An ADR is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, for which there is a reasonable possibility that the untoward occurrence is causally related to the medicinal product. ADRs are a subset of AEs for a given medicinal product.
- 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
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01706198?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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