Comparison · NCT03170362-sae
Intervention Group vs Delay Results Group: 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. Intervention Group vs Delay Results Group: serious adverse events. Trial comparisons, record NCT03170362-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03170362-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 | 0.0787 | 0.0633 | 0.0974 | wilson | |
| Risk in group 2 | 0.0716 | 0.057 | 0.0895 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0071 | -0.0165 | 0.0308 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.1 | 0.804 | 1.5 | log | |
| Odds ratio, group 1 over group 2 | 1.11 | 0.79 | 1.55 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Intervention Group than on Delay Results Group | 141 | 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 | Intervention Group | Pharmacogenetic test results will be provided to the provider within 72 hours of randomization in order to facilitate choice in selecting antidepressants.~Pharmacogenetic Test: The intervention is a battery of pharmacogenetic test results that mostly affect the metabolism of antidepressants and other medications. | 76 | 966 | EG000 |
| Group 2 | Delay Results Group | The comparator arm will not receive results at the time of randomization but will get results after the 24 week assessment (thus the results are delayed). | 70 | 978 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 24 weeks
Source ClinicalTrials.gov
Trial
- Title
- PRIME Care (PRecision Medicine In MEntal Health Care)
- NCT number
- NCT03170362
- Phases
- NA
- Conditions
- Major Depression
- Interventions
- Pharmacogenetic Test
- Lead sponsor
- VA Office of Research and Development
- Results first posted
- 2024-05-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03170362?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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