Comparison · NCT03467425-sae
FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI vs Non-Ellipta MITT: 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 /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI vs Non-Ellipta MITT: serious adverse events. Trial comparisons, record NCT03467425-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03467425-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 | 0.0738 | 0.0618 | 0.0879 | wilson | |
| Risk in group 2 | 0.0737 | 0.0617 | 0.0878 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0000954 | -0.0184 | 0.0186 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.78 | 1.29 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.765 | 1.31 | log | |
| Number needed to harm, for one more participant with a serious adverse event on FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI than on Non-Ellipta MITT | 10,500 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
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 |
|---|---|---|---|---|---|
| Group 1 | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | Eligible participants received a combination of fluticasone furoate (FF) blended with lactose in the first strip (100 microgram \[mcg\] per blister); and umeclidinium bromide (UMEC) and vilanterol (VI) blended with lactose and magnesium stearate in second strip (62.5 mcg UMEC per blister and 25 mcg VI per blister), a single inhalation once daily in the same TRELEGY ELLIPTA dry powder inhaler (DPI) via inhalation route for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician. | 114 | 1,545 | EG000 |
| Group 2 | Non-Ellipta MITT | Eligible participants received the inhaled corticosteroid (ICS)/long-acting muscarinic receptor antagonist (LAMA)/long-acting beta agonist (LABA) products twice daily as prescribed by the physician for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician. | 114 | 1,547 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Serious adverse events (SAEs) and non-serious AEs (non-SAEs) were collected from the start of study treatment up to Week 24
Source ClinicalTrials.gov
Trial
- Title
- INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design
- NCT number
- NCT03467425
- Phases
- PHASE4
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- FF/UMEC/VI, Inhaled Corticosteroid, LAMA, LABA, COPD rescue medications
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2020-09-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03467425?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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