Comparison · NCT05573464-sae
BGF MDI HFO 320/14.4/9.6 μg vs BGF MDI HFA 320/14.4/9.6 μg: 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. BGF MDI HFO 320/14.4/9.6 μg vs BGF MDI HFA 320/14.4/9.6 μg: serious adverse events. Trial comparisons, record NCT05573464-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05573464-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 | 0.0893 | 0.0612 | 0.128 | wilson | |
| Risk in group 2 | 0.0863 | 0.0587 | 0.125 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00295 | -0.045 | 0.0509 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.03 | 0.606 | 1.77 | log | |
| Odds ratio, group 1 over group 2 | 1.04 | 0.577 | 1.87 | log | |
| Number needed to harm, for one more participant with a serious adverse event on BGF MDI HFO 320/14.4/9.6 μg than on BGF MDI HFA 320/14.4/9.6 μg | 338 | 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 | BGF MDI HFO 320/14.4/9.6 μg | Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze) | 25 | 280 | EG000 |
| Group 2 | BGF MDI HFA 320/14.4/9.6 μg | Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA | 24 | 278 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 52 weeks
Source ClinicalTrials.gov
Trial
- Title
- A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With a Next-Generation Propellant in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
- NCT number
- NCT05573464
- Phases
- PHASE3
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- BGF MDI HFO 320/14.4/9.6 μg, BGF MDI HFA 320/14.4/9.6 μg
- Lead sponsor
- AstraZeneca
- Results first posted
- 2025-09-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05573464?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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GET https://conductscience.org/api/comparisons/v1/NCT05573464-sae