Comparison · NCT04536038-sae
Opt-in vs Opt-out: 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. Opt-in vs Opt-out: serious adverse events. Trial comparisons, record NCT04536038-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04536038-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 | 0.000256 | 0.0000452 | 0.00145 | wilson | |
| Risk in group 2 | 0.00316 | 0.00123 | 0.00809 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0029 | -0.00784 | -0.000634 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.081 | 0.00907 | 0.724 | log | |
| Odds ratio, group 1 over group 2 | 0.0808 | 0.00902 | 0.724 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Opt-in than on Opt-out | 345 | 128 | 1,580 | from the risk difference interval |
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 | Opt-in | Patients randomized to opt-in framing will be instructed to visit the Way to Health website to enroll in the study, or to call or email the study coordinator with questions or for assistance in enrolling. | 1 | 3,909 | EG000 |
| Group 2 | Opt-out | Patients randomized to opt-out framing will receive an email that frames participation in the study as part of the standard of care, and will be informed that a study coordinator will be calling them in the coming days to start enrollment in the study unless they opt out of participation.~Opt-out: A study coordinator will call the patient unless they opt-out. See arm description for more details. | 4 | 1,267 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 24 weeks
Source ClinicalTrials.gov
Trial
- Title
- Framing Clinical Trial Enrollment for Patients With Peripheral Artery Disease
- NCT number
- NCT04536038
- Phases
- NA
- Conditions
- Peripheral Artery Disease
- Interventions
- Opt-out
- Lead sponsor
- University of Pennsylvania
- Results first posted
- 2025-12-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04536038?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.govNone 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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