Comparison · NCT04234698-sae
Warfarin vs NOACs: 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. Warfarin vs NOACs: serious adverse events. Trial comparisons, record NCT04234698-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04234698-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 | 0.0893 | 0.0665 | 0.119 | wilson | |
| Risk in group 2 | 0.0272 | 0.0203 | 0.0363 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0621 | 0.0376 | 0.0925 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.28 | 2.17 | 4.96 | log | |
| Odds ratio, group 1 over group 2 | 3.51 | 2.26 | 5.44 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Warfarin than on NOACs | 16.1 | 10.8 | 26.6 | 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 | Warfarin | Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019. | 41 | 459 | EG000 |
| Group 2 | NOACs | Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019. | 44 | 1,617 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years); retrieved data was analyzed during approximately 2 months of this observational study
Source ClinicalTrials.gov
Trial
- Title
- Patient Characteristics, Treatment Patterns And Incidence Of Events (Discontinuation, Persistence, Key Primary Clinical Outcomes) In NVAF Patients Initiating OAC Therapy In Colombia
- NCT number
- NCT04234698
- Phases
- Conditions
- Atrial Fibrillation
- Interventions
- Lead sponsor
- Pfizer
- Results first posted
- 2025-02-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04234698?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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