Comparison · NCT01598831-a49ec47c
ART-123 vs Placebo: Number of Participants With On-Treatment Serious Major Bleeding 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. ART-123 vs Placebo: Number of Participants With On-Treatment Serious Major Bleeding Events. Trial comparisons, record NCT01598831-a49ec47c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01598831-a49ec47c
On this page
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 | 0.0581 | 0.039 | 0.0856 | wilson | |
| Risk in group 2 | 0.0396 | 0.0245 | 0.0634 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0185 | -0.012 | 0.0499 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.47 | 0.787 | 2.73 | log | |
| Odds ratio, group 1 over group 2 | 1.5 | 0.778 | 2.87 | log | |
| Number needed to treat, for one more participant with the outcome on ART-123 than on Placebo | 54.1 | 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 | 23 | 396 | OG000 |
| Group 2 | Placebo | Placebo Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days | 16 | 404 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With On-Treatment Serious Major Bleeding Events
- Description
On-treatment Serious Major Bleeding Events collected as Serious Adverse Events and defined as: any intracranial hemorrhage, any life-threatening bleeding, any bleeding event classified as serious by the Investigator (e.g., resulting in permanent morbidity), or any bleeding that required the administration of 1440 ml (typically 6 units) of packed red cells over two consecutive days. (Investigator assessment for seriousness criteria.)
- Time frame
- Through Study Day 28
- Population
Safety population: all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group)
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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01598831-a49ec47c