Comparison · NCT00927862-sae
PG Dosing Patients vs Historical Controls: 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. PG Dosing Patients vs Historical Controls: serious adverse events. Trial comparisons, record NCT00927862-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00927862-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 | 0.0452 | 0.03 | 0.0674 | wilson | |
| Risk in group 2 | 0.0939 | 0.081 | 0.109 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0487 | -0.0698 | -0.023 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.481 | 0.312 | 0.743 | log | |
| Odds ratio, group 1 over group 2 | 0.457 | 0.289 | 0.722 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on PG Dosing Patients than on Historical Controls | 20.5 | 14.3 | 43.6 | 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 | PG Dosing Patients | Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the pharmacogenetic (PG)-dosing algorithms (standard or modified IWPC warfarin algorithms) | 22 | 487 | EG000 |
| Group 2 | Historical Controls | A parallel, clinical effectiveness comparison group that used an algorithm with standard dosing | 162 | 1,726 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Patients were included in the SAE safety analyses if they received an INR measurement on Day 4 or 5 and were taking warfarin. Patients were followed until 3 months after warfarin initiation.
Source ClinicalTrials.gov
Trial
- Title
- Applying Pharmacogenetic Algorithms to Individualize Dosing of Warfarin
- NCT number
- NCT00927862
- Phases
- PHASE2, PHASE3
- Conditions
- Thromboembolism
- Interventions
- IWPC adapted genotype-guided dosing algorithm for warfarin, Modified IWPC genetic-guided warfarin dosing algorithm, Standard of care treatment
- Lead sponsor
- Intermountain Health Care, Inc.
- Results first posted
- 2012-09-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00927862?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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