Comparison · NCT03137303-sae
Patient-Subject Intervention vs Patient Subject Usual Care: 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. Patient-Subject Intervention vs Patient Subject Usual Care: serious adverse events. Trial comparisons, record NCT03137303-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03137303-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 | 0 | 0.022 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0164 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0164 | 0.022 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: usual care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Patient-Subject Intervention | Patients were assigned to the arm group based on the randomization of their primary care provider. The intervention group completed the spirometry test (pre and post BD) during T0 - baseline visit. | 0 | 171 | EG001 |
| Group 2 | Patient Subject Usual Care | Patients were assigned to the arm group based on the randomization of their primary care provider. The usual care group completed the spirometry test (pre and post BD) during the T4 - 12-month follow-up visit (following the same spirometry protocol as the intervention group did at T0 - baseline visit). | 0 | 231 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Reducing Diagnostic Error to Improve Patient Safety in COPD and Asthma (REDEFINE Study)
- NCT number
- NCT03137303
- Phases
- PHASE3
- Conditions
- COPD Asthma
- Interventions
- Spirometry at initial visit, Albuterol, Spirometry at 12-month follow-up
- Lead sponsor
- University of Illinois Chicago
- Results first posted
- 2021-07-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03137303?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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