Trial · NCT03403751
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Freedom From Durable Loss of Renal Function at Day 28 | 28 Days | This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed necrotizing soft tissue infection (NSTI) and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Serious Adverse Events (SAEs) | 28 Days | This analysis population (As Treated/Safety Analysis Set) included all randomized patients who were exposed to study drug (reltecimod or placebo), with patients analyzed according to the treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Adverse Events (AEs) | 28 Days | This analysis population (As Treated/Safety Analysis Set) included all randomized patients who were exposed to study drug (reltecimod or placebo), with patients analyzed according to the treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Freedom From Durable Loss of Renal Function at Day 14 | 14 Days | This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Intensive Care Unit (ICU)-Free Days | 28 Days | This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. | days | MEDIAN |
| SECONDARY | Ventilator-free Days | 28 Days | This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. | days | MEDIAN |
| SECONDARY | Vasopressor-free Days | 28 Days | This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. | days | MEDIAN |
| SECONDARY | Hospital Days | 90 Days | This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. | days | MEDIAN |
| SECONDARY | Cumulative Number of Deaths | 90 Days | This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Secondary Infections | 28 Days | This analysis population (As Treated/Safety Analysis Set) included all randomized patients who were exposed to study drug (reltecimod or placebo), with patients analyzed according to the treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | ICU-free Days by Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Category | 28 Days | This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients with available mSOFA data are included in the analysis. | days | MEDIAN |
| SECONDARY | Ventilator-free Days by Day 14 mSOFA Category | 28 Days | This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients with available mSOFA data are included in the analysis. | days | MEDIAN |
| SECONDARY | Vasopressor-free Days by Day 14 mSOFA Category | 28 Days | This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients with available mSOFA data are included in the analysis. | days | MEDIAN |
| SECONDARY | Hospital Days by Day 14 mSOFA Category | 90 Days | This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients with available mSOFA data are included in the analysis. | days | MEDIAN |
| SECONDARY | Hospital Discharge Location by Day 14 mSOFA Category | 90 Days | This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients alive at Day 14 with available data are included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Cumulative Mortality by Day 14 mSOFA Category | 90 Days | This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients with a screening mSOFA \>= 3 are included in the analysis. | percentage of patients | NUMBER |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT03403751/outcomes