Comparison · NCT00297102-sae
Roflumilast 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. Roflumilast vs Placebo: serious adverse events. Trial comparisons, record NCT00297102-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00297102-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 | 0.187 | 0.161 | 0.216 | wilson | |
| Risk in group 2 | 0.203 | 0.176 | 0.233 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0154 | -0.0552 | 0.0244 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.924 | 0.753 | 1.13 | log | |
| Odds ratio, group 1 over group 2 | 0.907 | 0.703 | 1.17 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Roflumilast than on Placebo | 65 | 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 | Roflumilast | 500 mcg, once daily, oral administration in the morning | 144 | 769 | EG000 |
| Group 2 | Placebo | once daily | 153 | 755 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 52 weeks treatment period
Source ClinicalTrials.gov
Trial
- Title
- Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)
- NCT number
- NCT00297102
- Phases
- PHASE3
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Roflumilast, Placebo
- Lead sponsor
- AstraZeneca
- Results first posted
- 2011-05-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00297102?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT00297102-sae