Comparison · NCT00988247-sae
BDP HFA 320 µg/Day 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. BDP HFA 320 µg/Day vs Placebo: serious adverse events. Trial comparisons, record NCT00988247-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00988247-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 | 0.0193 | 0.0098 | 0.0376 | wilson | |
| Risk in group 2 | 0.027 | 0.00923 | 0.0765 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00775 | -0.0581 | 0.0178 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.713 | 0.192 | 2.64 | log | |
| Odds ratio, group 1 over group 2 | 0.708 | 0.185 | 2.71 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on BDP HFA 320 µg/Day than on Placebo | 129 | 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 | BDP HFA 320 µg/Day | During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning. | 8 | 415 | EG000 |
| Group 2 | Placebo | During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning. | 3 | 111 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis
- NCT number
- NCT00988247
- Phases
- PHASE3
- Conditions
- Rhinitis, Allergic, Perennial
- Interventions
- Beclomethasone dipropionate, Placebo Nasal Aerosol
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Results first posted
- 2012-05-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00988247?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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