Comparison · NCT04401293-sae
Full Dose LMWH Anticoagulation Therapy vs Prophylactic/Intermediate Dose LMWH or UFH Therapy: 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. Full Dose LMWH Anticoagulation Therapy vs Prophylactic/Intermediate Dose LMWH or UFH Therapy: serious adverse events. Trial comparisons, record NCT04401293-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04401293-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 | 0.0155 | 0.00426 | 0.0548 | wilson | |
| Risk in group 2 | 0 | 0 | 0.03 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0155 | -0.0166 | 0.0548 | 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, for one more participant with a serious adverse event on Full Dose LMWH Anticoagulation Therapy than on Prophylactic/Intermediate Dose LMWH or UFH Therapy | 64.5 | 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 | Full Dose LMWH Anticoagulation Therapy | Subjects in this study arm will be treated with therapeutic doses of subcutaneous low-molecular-weight heparin (enoxaparin). Enoxaparin 1mg/kg SQ BID for CrCl ≥ 30ml/min (or Enoxaparin 0.5mg/kg SQ BID for CrCl ≥ 15ml/min and \< 30ml/min) during the course of their hospitalization.~Enoxaparin: Full Dose LMWH anticoagulation therapy | 2 | 129 | EG000 |
| Group 2 | Prophylactic/Intermediate Dose LMWH or UFH Therapy | Subjects in this study arm will be treated with Local institutional standard-of-care for prophylactic-dose or intermediate-dose UFH or LMWH. Regimens allowed are UFH up to 22,500 IU daily in BID or TID doses (i.e. UFH 5000 IU SQ BID/TID or 7500 IU BID/TID), enoxaparin 30mg and 40mg SQ QD or BID (the use of weight-based enoxaparin i.e. 0.5mg/kg SQ BID for this arm is acceptable but strongly discouraged), dalteparin 2500IU or 5000IU QD.~Prophylactic/Intermediate Dose Enoxaparin: Prophylactic/Intermediate Dose LMWH or UFH therapy | 0 | 124 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From screening/randomization, adverse event data was monitored and collected for each participant for 30 days (± 2 days), which was their duration in the study.
Source ClinicalTrials.gov
Trial
- Title
- Full Dose Heparin Vs. Prophylactic Or Intermediate Dose Heparin in High Risk COVID-19 Patients
- NCT number
- NCT04401293
- Phases
- PHASE3
- Conditions
- Sars-CoV2, COVID
- Interventions
- Enoxaparin, Prophylactic/Intermediate Dose Enoxaparin
- Lead sponsor
- Northwell Health
- Results first posted
- 2021-11-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04401293?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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