Comparison · NCT03985852-sae
Patient Directed Standard of Care vs Enhanced Standard of 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
Cite this record
ConductScience Library. Patient Directed Standard of Care vs Enhanced Standard of Care: serious adverse events. Trial comparisons, record NCT03985852-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03985852-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 | 0.000000000000000000217 | 0.00247 | wilson | |
| Risk in group 2 | 0 | 0 | 0.00252 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.00252 | 0.00247 | 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
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 | Patient Directed Standard of Care | Patients receive pre-test genetic counseling and, if relevant, post-test counseling for a negative result from an automated genetics education assistant.~Patient Directed Standard of Care: The pre-test genetic counseling visit will be conducted through access to an automated genetics education assistant accessed through the patient portal. The automated approach will address all the components of the pre-test counseling and contains content designed by the genetic counselors at the University of Utah and NYU. Patients will have the option to contact genetic counselors through the patient portal, by phone, or in person but this will not be required. All results will be reviewed by a genetic counselor. Negative results will be returned by the automated genetics education assistant. Genetic counselors will return results for pathogenic variants and variants of uncertain significance via phone. | 0 | 1,554 | EG000 |
| Group 2 | Enhanced Standard of Care | Patients receive standard counseling from a genetic counselor. | 0 | 1,519 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Broadening the Reach, Impact, and Delivery of Genetic Services
- NCT number
- NCT03985852
- Phases
- NA
- Conditions
- Cancer, Risk Reduction Behavior
- Interventions
- Patient Directed Standard of Care
- Lead sponsor
- University of Utah
- Results first posted
- 2025-01-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03985852?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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