Comparison · NCT01966107-sae
Aclidinium Bromide 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
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ConductScience Library. Aclidinium Bromide vs Placebo: serious adverse events. Trial comparisons, record NCT01966107-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01966107-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 | 0.228 | 0.21 | 0.248 | wilson | |
| Risk in group 2 | 0.198 | 0.18 | 0.217 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0304 | 0.00356 | 0.0571 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.15 | 1.02 | 1.31 | log | |
| Odds ratio, group 1 over group 2 | 1.2 | 1.02 | 1.41 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Aclidinium Bromide than on Placebo | 32.9 | 17.5 | 281 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Aclidinium Bromide | Randomized subjects were administered Aclidinium bromide 400 μg BID, once in the morning and once in the evening (approximately 12 hours apart), via a multi-dose dry powder inhalation device (DPI). Subjects on a LAMA (long-acting muscarinic antagonist i.e., inhaled anticholinergics) had to washout 2 weeks prior to randomization. | 409 | 1,791 | EG000 |
| Group 2 | Placebo | Randomized subjects were administered placebo, once in the morning and once in the evening (approximately 12 hours apart), via a multi-dose DPI. Subjects on a LAMA (ie, inhaled anticholinergics) had to washout 2 weeks prior to randomization. | 356 | 1,798 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Any adverse event occurring from the time the informed consent form was signed until 15 days after the last dose of study drug were recorded. Adverse events were collected at Visit 1A for subjects who completed a Visit 0.
Source ClinicalTrials.gov
Trial
- Title
- Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in Moderate to Very Severe COPD Patients.
- NCT number
- NCT01966107
- Phases
- PHASE4
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease, Moderate to Very Severe COPD
- Interventions
- Aclidinium Bromide, Placebo
- Lead sponsor
- AstraZeneca
- Results first posted
- 2018-12-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01966107?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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