Comparison · NCT02889809-sae
FF 50 mcg vs Placebo: serious adverse events
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 50 mcg vs Placebo: serious adverse events. Trial comparisons, record NCT02889809-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02889809-sae
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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 | 0.0252 | 0.0116 | 0.0539 | wilson | |
| Risk in group 2 | 0.0335 | 0.0171 | 0.0646 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00826 | -0.0423 | 0.0248 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.753 | 0.265 | 2.14 | log | |
| Odds ratio, group 1 over group 2 | 0.747 | 0.255 | 2.19 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on FF 50 mcg than on Placebo | 121 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | FF 50 mcg | Participants received received a single-blind placebo inhaler during a 16-week run-in period. After run-in period inhaled FF 50 mcg was administered via ELLIPTA inhaler once daily in the morning for 52 weeks during double-blind treatment period. Participants also received open-label montelukast one tablet orally in the evening (4 mg for participants who were 5 years old and 5 mg for participants who were \>=6 years old) as background therapy from the run-in period through to the end of follow-up (8 weeks) period. | 6 | 238 | EG001 |
| Group 2 | Placebo | Participants received a single-blind placebo inhaler during a 16-week run-in period. After run-in period inhaled placebo was administered once daily (OD) in the morning for 52 weeks during the double-blind treatment period. Participants also received open-label montelukast one tablet orally in the evening (4 milligrams \[mg\] for participants who were 5 years old and 5 mg for participants who were greater than or equal to \[\>=\] 6 years old) as background therapy from the run-in period through to the end of follow-up (8 weeks) period. | 8 | 239 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All cause mortality, non-serious adverse events (AEs) and serious AEs were collected up to 76 weeks
Source ClinicalTrials.gov
Trial
- Title
- Effects of a Orally Inhaled Fluticasone Furoate on Growth Velocity in Prepubertal, Paediatric Subjects With Asthma Over a Year
- NCT number
- NCT02889809
- Phases
- PHASE4
- Conditions
- Asthma
- Interventions
- Fluticasone furoate, Placebo, Montelukast, Short Acting Beta 2 Agonist
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2022-01-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02889809?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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