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Trial · NCT03511105

Outcomes26

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYBaseline Adjusted Total Protein Concentration in Broncho-alveolar (BAL) Samples at 24 Hours After Segmental LPS Challenge (26 Hours Post-first Dose)Baseline and at 26 hours post-first doseEvaluable Population.Milligrams per literMEDIAN
SECONDARYBaseline Adjusted Total Cell Count of Neutrophils in BAL Samples at 24 Hours After Segmental LPS Challenge (26 Hours Post-first Dose)Baseline and at 26 hours post-first doseEvaluable Population.10^6 cells per milliliterMEDIAN
SECONDARYBaseline Adjusted Differential Cell Count of Neutrophils in BAL Samples at 24 Hours After Segmental LPS Challenge (26 Hours Post-first Dose)Baseline and at 26 hours post-first doseEvaluable Population.Percentage of total cell countMEDIAN
SECONDARYNumber of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEsUp to Day 9 (FU/EW)All Subjects Population.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYChange From Baseline Values for Clinical Chemistry ParametersBaseline (Day -1) and at Day 2 and Day 9 (FU/EW)All Subjects Population.International units per literMEAN
SECONDARYChange From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and CreatinineBaseline (Day -1) and at Day 2 and Day 9 (FU/EW)All Subjects Population.Micromoles per literMEAN
SECONDARYChange From Baseline Values for Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)Baseline (Day -1) and at Day 2 and Day 9 (FU/EW)All Subjects Population.Millimoles per literMEAN
SECONDARYChange From Baseline Values for Clinical Chemistry Parameter-C Reactive Protein (CRP)Baseline (Day -1) and at Day 2 and Day 9 (FU/EW)All Subjects Population.Milligrams per literMEAN
SECONDARYChange From Baseline Values for Clinical Chemistry Parameter-Total ProteinBaseline (Day -1) and at Day 2 and Day 9All Subjects Population.Grams per literMEAN
SECONDARYChange From Baseline Values for Hematology ParametersBaseline (Day -1) and at Day 2 and Day 9 (FU/EW)All Subjects Population.Giga cells per literMEAN
SECONDARYChange From Baseline Values for Hematology Parameter: HemoglobinBaseline (Day -1) and at Day 2 and Day 9 (FU/EW)All Subjects Population.Grams per literMEAN
SECONDARYChange From Baseline Values for Hematology Parameters: Hematocrit and ReticulocytesBaseline (Day -1) and at Day 2 and Day 9 (FU/EW)All Subjects Population.Percentage of red blood cells in bloodMEAN
SECONDARYChange From Baseline Values for Hematology Parameter: Mean Corpuscular Hemogloblin (MCH)Baseline (Day -1) and at Day 2 and Day 9 (FU/EW)All Subjects Population.PicogramsMEAN
SECONDARYChange From Baseline Values for Hematology Parameter: Mean Corpuscular Volume (MCV)Baseline (Day -1) and at Day 2 and Day 9 (FU/EW)All Subjects Population.FemtolitersMEAN
SECONDARYChange From Baseline Values for Hematology Parameter: Red Blood Cell (RBC) CountBaseline (Day -1)and at Day 2 and Day 9 (FU/EW)All Subjects Population.Tera cells per literMEAN
SECONDARYChange From Baseline in Urine Potential of Hydrogen (pH)Baseline (Day -1) and at Day 2 and Day 9 (FU/EW)All Subjects Population.pHMEAN
SECONDARYChange From Baseline in Urine Specific GravityBaseline (Day -1) and at Day 2 and Day 9 (FU/EW)All Subjects Population.RatioMEAN
SECONDARYNumber of Participants With Worst Case Post Baseline Abnormal Electrocardiogram (ECG) FindingsUp to Day 9 (FU/EW)All Subjects Population.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Abnormal Findings During Physical ExaminationsUp to Day 9 (FU/EW)Safety Population. This analysis was not planned and data was not collected and captured in the database.
SECONDARYChange From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)Baseline (Day -1) and at 1, 6, 12, 14, 30 hours and Day 9 (FU/EW)All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).Millimeters of mercuryMEAN

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone 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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