MF/F MDI BID vs MF MDI BID: 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 | 0.0232 | 0.0196 | 0.0273 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0234 | 0.0198 | 0.0276 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.000198 | -0.00569 | 0.00529 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.992 | 0.784 | 1.25 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.991 | 0.78 | 1.26 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with a serious adverse event on MF/F MDI BID than on MF MDI BID | 5,040 | 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 | MF/F MDI BID | 136 | 5,868 | EG000 | ClinicalTrials.gov | |
| Group 2 | MF MDI BID | 137 | 5,861 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | 26 weeks, or 7 days after the last treatment dose, whichever occurred later | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241) | ClinicalTrials.gov |
| NCT number | NCT01471340 | ClinicalTrials.gov |
| Phases | PHASE4 | ClinicalTrials.gov |
| Conditions | Asthma | ClinicalTrials.gov |
| Interventions | Mometasone Furoate/Formoterol MDI 100/5 mcg, Mometasone Furoate/Formoterol MDI 200/5 mcg, Mometasone Furoate MDI 100 mcg, Mometasone Furoate MDI 200 mcg, Albuterol 90 mcg /salbutamol 100 mcg HFA MDI, Prednisone/prednisolone | ClinicalTrials.gov |
| Lead sponsor | Organon and Co | ClinicalTrials.gov |
| Results first posted | 2018-01-05 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01471340?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.