Fluticasone Propionate/Salmeterol Combination (FSC) vs Fluticasone Propionate (FP): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.023 | 0.0194 | 0.0271 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0214 | 0.018 | 0.0254 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.00158 | -0.00379 | 0.00697 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.07 | 0.844 | 1.37 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.08 | 0.841 | 1.38 | log | ClinicalTrials.gov | |
| Number needed to harm, for one more participant with a serious adverse event on Fluticasone Propionate/Salmeterol Combination (FSC) than on Fluticasone Propionate (FP) | 632 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Fluticasone Propionate/Salmeterol Combination (FSC) | Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication. | 134 | 5,834 | EG000 | ClinicalTrials.gov |
| Group 2 | Fluticasone Propionate (FP) | Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication. | 125 | 5,845 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks). | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma. | ClinicalTrials.gov |
| NCT number | NCT01475721 | ClinicalTrials.gov |
| Phases | PHASE4 | ClinicalTrials.gov |
| Conditions | Asthma | ClinicalTrials.gov |
| Interventions | ADVAIR 100/50mcg, ADVAIR 250/50mcg, ADVAIR 500/50mcg, FLOVENT 100mcg, FLOVENT 250mcg, FLOVENT 500mcg | ClinicalTrials.gov |
| Lead sponsor | GlaxoSmithKline | ClinicalTrials.gov |
| Results first posted | 2016-01-14 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01475721?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.