Comparison · NCT00900731-sae
Indacaterol 150 μg vs Tiotropium 18 μg: 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. Indacaterol 150 μg vs Tiotropium 18 μg: serious adverse events. Trial comparisons, record NCT00900731-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00900731-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 | 0.0277 | 0.0184 | 0.0416 | wilson | |
| Risk in group 2 | 0.0375 | 0.0264 | 0.0531 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00984 | -0.028 | 0.00795 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.738 | 0.429 | 1.27 | log | |
| Odds ratio, group 1 over group 2 | 0.73 | 0.418 | 1.28 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Indacaterol 150 μg than on Tiotropium 18 μg | 102 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
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 |
|---|---|---|---|---|---|
| Group 1 | Indacaterol 150 μg | Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication. | 22 | 794 | EG000 |
| Group 2 | Tiotropium 18 μg | Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication. | 30 | 799 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 12 weeks
Source ClinicalTrials.gov
Trial
- Title
- A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)
- NCT number
- NCT00900731
- Phases
- PHASE3
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Indacaterol 150 μg, Tiotropium 18 μg, Placebo to indacaterol, Placebo to tiotropium
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2011-08-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00900731?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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