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Trial · NCT00604214

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARY28-Day All-Cause MortalityDay 28All randomized participants with known mortality status at Day 28.percentage of participantsNUMBER
SECONDARY28-Day All-Cause Mortality in Participants With Severe Protein C DeficiencyDay 28All randomized participants with severe protein C deficiency at Baseline with known mortality status at Day 28.percentage of participantsNUMBER
SECONDARYAverage Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28Day 1 through Day 28
All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.
units on a scaleMEAN
SECONDARYAverage Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28Day 1 through Day 28
All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.
units on a scaleMEAN
SECONDARYAverage Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28Day 1 through Day 28
All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.
units on a scaleMEAN
SECONDARY90-Day MortalityDay 90All randomized participants with known mortality status at Day 90.percentage of participantsNUMBER
SECONDARY180-Day MortalityDay 180All randomized participants with known mortality status at Day 180.percentage of participantsNUMBER
SECONDARYMedian Survival TimeDay 180All randomized participants excluding those with unknown mortality status at Day 180.daysMEDIAN
SECONDARYEuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180Baseline and Days 28 and 90 and 180All randomized participants with EQ-5D VAS data at the specified time points.units on a scaleMEAN
SECONDARYEuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180Baseline and Days 28 and 90 and 180All randomized participants with EQ-5D total score data at the specified time points.units on a scaleMEAN
SECONDARYQuality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180Baseline and Days 28 and 90 and 180All randomized participants with SF-12 score data at the specified time points.units on a scaleMEDIAN
OTHER_PRE_SPECIFIEDPercentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From Baseline Through Day 28Baseline through Day 28Participants who received study drug.percentage of participantsNUMBER
SECONDARYPercentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 EndpointBaseline through Day 28Participants who received study drug.percentage of participantsNUMBER

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
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
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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GET https://conductscience.org/api/trials/v1/NCT00604214/outcomes