Comparison · NCT01598831-e215370b
ART-123 vs Placebo: Number of Participants With 28-Day All-cause Mortality
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. ART-123 vs Placebo: Number of Participants With 28-Day All-cause Mortality. Trial comparisons, record NCT01598831-e215370b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01598831-e215370b
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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 | 0.268 | 0.227 | 0.314 | wilson | |
| Risk in group 2 | 0.294 | 0.252 | 0.34 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0255 | -0.0874 | 0.0368 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.913 | 0.731 | 1.14 | log | |
| Odds ratio, group 1 over group 2 | 0.882 | 0.647 | 1.2 | log | |
| Number needed to treat, for one fewer participant with the outcome on ART-123 than on Placebo | 39.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | ART-123 | ART-123 (human recombinant thrombomodulin, thrombomodulin alfa) Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days | 106 | 395 | OG000 |
| Group 2 | Placebo | Placebo Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days | 119 | 405 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With 28-Day All-cause Mortality
- Description
- 28-Day All-cause Mortality
- Time frame
- 28 days
- Population
- Full Analysis Set - All randomized and dosed subjects.
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy
- NCT number
- NCT01598831
- Phases
- PHASE3
- Conditions
- Severe Sepsis, Coagulopathy
- Interventions
- ART-123, Placebo
- Lead sponsor
- Asahi Kasei Pharma America Corporation
- Results first posted
- 2020-04-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01598831?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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