Comparison · NCT01443845-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 NCT01443845-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01443845-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 | 0.153 | 0.133 | 0.174 | wilson | |
| Risk in group 2 | 0.138 | 0.119 | 0.159 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0148 | -0.0137 | 0.0433 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.11 | 0.91 | 1.35 | log | |
| Odds ratio, group 1 over group 2 | 1.13 | 0.896 | 1.42 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Roflumilast than on Placebo | 67.5 | 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 | Roflumilast 500 µg, oral administration, once per day | 180 | 1,178 | EG001 |
| Group 2 | Placebo | Dose-matched placebo, oral administration, once per day. | 162 | 1,174 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event data was collected from the start of the 52-week double-blind treatment period, to 30 days after the end of treatment.
Source ClinicalTrials.gov
Trial
- Title
- Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
- NCT number
- NCT01443845
- Phases
- PHASE4
- Conditions
- COPD, COPD Exacerbation, Lung Diseases, Respiratory Disorders, Pulmonary Disease, Chronic Obstructive Lung Diseases, Chronic Obstructive Airway Disease
- Interventions
- Roflumilast, Placebo
- Lead sponsor
- AstraZeneca
- Results first posted
- 2017-01-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01443845?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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