AZD9773 Dose Escalation Study | NCT00615017 | Trialant
NCT00615017
Sponsor
AstraZeneca
Status
Completed
Last Update Posted
Aug 22, 2013Estimated
Enrollment
70Actual
Phase
Phase 2
Conditions
Severe Sepsis
Interventions
AZD9773 (CytoFab)
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00615017
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D0620C00004
Secondary IDs
Not provided
Brief Title
AZD9773 Dose Escalation Study
Official Title
A Placebo-controlled, Double-blind, Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of Single and Multiple Intravenous Infusions of CytoFab (AZD9773) in Patients With Severe Sepsis
Acronym
Not provided
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Jul 2013
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 2008
Primary Completion Date
Jul 2009Actual
Completion Date
Jul 2009Actual
First Submitted Date
Jan 31, 2008
First Submission Date that Met QC Criteria
Feb 1, 2008
First Posted Date
Feb 14, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 30, 2012
Results First Submitted that Met QC Criteria
Jul 19, 2013
Results First Posted Date
Aug 22, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 19, 2013
Last Update Posted Date
Aug 22, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a double-blind, placebo-controlled, multi-center, dose-escalation study to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single and multiple ascending intravenous infusions of CytoFab (AZD9773) in adult patients with severe sepsis.
Detailed Description
Not provided
Conditions Module
Conditions
Severe Sepsis
Keywords
Sepsis
septic shock
Systemic Inflammatory Response Syndrome
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
70Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
AZD9773 cohort 1 (50 units/kg)
Experimental
AZD9773: single infusion of 50 units/kg
Drug: AZD9773 (CytoFab)
AZD9773 cohort 2 (250 units/kg)
Experimental
AZD9773: single infusion of 250 units/kg
Drug: AZD9773 (CytoFab)
AZD9773 cohort 3 (250/50 units/kg)
Experimental
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
Drug: AZD9773 (CytoFab)
AZD9773 cohort 4 (500/100 units/kg)
Experimental
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
Drug: AZD9773 (CytoFab)
AZD9773 cohort 5 (750/250 units/kg)
Experimental
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
Drug: AZD9773 (CytoFab)
Placebo
Placebo Comparator
Interventions
Name
Type
Description
Arm Group Labels
Other Names
AZD9773 (CytoFab)
Drug
intravenous infusions
AZD9773 cohort 1 (50 units/kg)
AZD9773 cohort 2 (250 units/kg)
AZD9773 cohort 3 (250/50 units/kg)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Creatinine Values
Change in creatinine values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
End of study (Day 28)
Change From Baseline in Alanine Aminotransferase Values
Change in alanine aminotransferase values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
End of study (Day 28)
Change From Baseline in Aspartate Aminotransferase Values
Change in aspartate aminotransferase values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
End of study (Day 28)
Change From Baseline in Bilirubin Values
Change in bilirubin values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
End of study (Day 28)
Change From Baseline in Haemoglobin Values
Change in haemoglobin values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
End of study (Day 28)
Secondary Outcomes
Measure
Description
Time Frame
28-Day Mortality
The number of patients who had died at Day 28. Safety analysis set (ie all patients who started study drug infusion).
End of study (Day 28)
Change From Baseline in Sequential Organ Failure Assessment (SOFA) Scores
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Clinical evidence of infection requiring treatment with parenteral antibiotics
Patients must meet multiple Systemic Inflammatory Response Syndrome (SIRS) criteria
Patients must meet criteria for cardiovascular and/or respiratory dysfunction
Sepsis (infection plus SIRS criteria) must be present prior to organ dysfunction
Exclusion Criteria:
Moribund and death is considered imminent, or patient not expected to survive 90 days because of underlying medical condition, or classified as Do Not Resuscitate or Do Not Treat
Patient cannot attain a MAP >60 mmHg when measured via an arterial line and/or a Systolic Blood Pressure (SBP) >80 mmHg in the presence of vasopressors and iv fluids for a period of ≥2 hours
Receiving immunosuppressants, or high dose steroids within 2 months of provision of informed consent
Any history of hypersensitivity reaction to sheep products, latex, papain or papaya, or chymopapain or previously administered antivenom manufactured using ovine serum, digoxin immune fab (DigiFab™ , DIGIBIND® ), crotalidae polyvalent immune fab (ovine) (CroFab™ ), or other sheep derived product.
Treatment with anti Tumor-Necrosis-Factor (anti-TNF) antibodies within 8 weeks before provision of written informed consent.
Yates JW, Das S, Mainwaring G, Kemp J. Population pharmacokinetic/pharmacodynamic modelling of the anti-TNF-alpha polyclonal fragment antibody AZD9773 in patients with severe sepsis. J Pharmacokinet Pharmacodyn. 2012 Dec;39(6):591-9. doi: 10.1007/s10928-012-9270-4. Epub 2012 Sep 23.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
70 adult patients with severe sepsis, clinical evidence of infection requiring parenteral antibiotics, meeting systemic inflammatory response syndrome criteria, and with cardiovascular/respiratory dysfunction were randomised to receive AZD9773 (2 single dose and 3 multiple dose cohorts) in a double-blind, placebo controlled, dose escalation study
Recruitment Details
The first patient was enrolled on January 18, 2008 and the last patient had their last visit on July 30, 2009. Patients were randomised at 17 centres in the United States of America
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
FG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Placebo
Other: Placebo
AZD9773 cohort 4 (500/100 units/kg)
AZD9773 cohort 5 (750/250 units/kg)
Placebo
Other
Placebo
Placebo
Change From Baseline in White Blood Cell Values
Change in white blood cell values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
End of study (Day 28)
Change From Baseline in Platelet Count Values
Change in platelet count values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
End of study (Day 28)
Change From Baseline in Prothrombin Time Values
Change in prothrombin time values from baseline (pre-infusion) to Day 7 [calculated as Day 7 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
Day 7
Change From Baseline in Troponin I
Change in troponin I values from baseline (pre-infusion) to Day 6 [calculated as Day 6 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
Day 6
Change From Baseline in QT With Fridericia Correction (QTcF), Where QT is Measured by ECG, and is the Time Interval Between the Start of the Q Wave and the End of the T Wave in the Heart's Electrical Cycle.
Change in QTcF from baseline (pre-infusion) to Day 1 (end of infusion) for Cohorts 1 and 2 [calculated as Day 1 mean minus baseline mean] and Day 5 (end of infusion) for Cohorts 3 to 5 and placebo [calculated as Day 5 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
Day 1 (end of infusion) for Cohorts 1 and 2; Day 5 (end of infusion) for Cohorts 3 to 5 and placebo
Change From Baseline in Calculated Mean Arterial Blood Pressure
Change in calculated mean arterial pressure from baseline (pre-infusion) to Day 14 [calculated as Day 14 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
Day 14
Change From Baseline in Body Weight
Change in body weight from baseline (pre-infusion) to Day 6 [calculated as Day 6 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
Day 6
Change in SOFA (Sequential Organ Failure Assessment) scores from baseline (pre-infusion) to Day 6 [calculated as Day 6 mean minus baseline mean]. The SOFA score is out of a maximum of 24 (units on a scale 0 to 24). The higher the score, the worse the organ system functioning. Safety analysis set (ie all patients who started study drug infusion).
Day 6
Area Under the Serum Concentration-time Curve From 0 to 12 Hours (AUC(0-12)) of Single Dose AZD9773 Serum Total Fabs (Cohorts 1 and 2)
AUC(0-12) for single dose AZD9773 serum total Fabs (cohorts 1 and 2). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).
Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8, and 12h post-(last) infusion]
Terminal Half-life (t1/2) of Single Dose AZD9773 Serum Total Fabs (Cohorts 1 and 2)
t1/2 of single dose AZD9773 serum total Fabs (cohorts 1 and 2). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).
Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8, 12, 24, 48, and 72 h post-(last) infusion]
Total Apparent Clearance (CL) of Single Dose AZD9773 Serum Total Fabs (Cohorts 1 and 2)
CL of single dose AZD9773 serum total Fabs (cohorts 1 and 2). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).
Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8, 12, 24, 48, and 72 h post-(last) infusion]
AUC(0-12) of Loading Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)
AUC(0-12) of loading dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).
Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8 and 12 h post-(last) infusion]
Maximum (End of Infusion) Serum Concentration (Cinf) of Loading Dose AZD9773 Serum Total Fabs (Cohorts 3,4 and 5)
Cinf of loading dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).
Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8 and 12 h post-(last)infusion]
Time to Reach Cinf (Tmax) of Loading Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)
tmax of loading dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).
Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8 and 12 h post-(last)infusion]
AUC(0-12) of Maintenance Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)
AUC(0-12) of maintenance dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).
PK samples taken pre-dose of Doses 5,7 and 9, then at 0, 0.5, 1, 2, 8 and 12 h post dose 9 infusion
Cinf of Maintenance Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)
Cinf of maintenance dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).
PK samples taken pre-dose of Doses 5,7 and 9, then at 0, 0.5, 1, 2, 8 and 12 h post dose 9 infusion
Tmax of Maintenance Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)
tmax of maintenance dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).
PK samples taken pre-dose of Doses 5,7 and 9, then at 0, 0.5, 1, 2, 8 and 12 h post dose 9 infusion
Number of Patients Below Tumour Necrosis Factor (TNF)-Alpha Limit of Quantification (LOQ) at 24 Hours (n< LOQ)
Number of patients below tumour necrosis factor (TNF)-alpha limit of quantification (LOQ) at 24 hours (n< LOQ) measured by ELISA (LOQ = 1.3 pg/mL). Safety analysis set (ie all patients who started study drug infusion).
24 hours
Newark
Delaware
United States
Research Site
Bay Pines
Florida
United States
Research Site
Miami
Florida
United States
Research Site
Chicago
Illinois
United States
Research Site
Oak Park
Illinois
United States
Research Site
Peoria
Illinois
United States
Research Site
Indianapolis
Indiana
United States
Research Site
Iowa City
Iowa
United States
Research Site
Hazard
Kentucky
United States
Research Site
Lexington
Kentucky
United States
Research Site
Baltimore
Maryland
United States
Research Site
Kansas City
Missouri
United States
Research Site
Camden
New Jersey
United States
Research Site
Newark
New Jersey
United States
Research Site
Brooklyn
New York
United States
Research Site
New York
New York
United States
Research Site
Rochester
New York
United States
Research Site
Durham
North Carolina
United States
Research Site
Greensboro
North Carolina
United States
Research Site
Winston-Salem
North Carolina
United States
Research Site
Columbus
Ohio
United States
Research Site
Oklahoma City
Oklahoma
United States
Research Site
Nashville
Tennessee
United States
Research Site
Galveston
Texas
United States
Research Site
Houston
Texas
United States
FG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
FG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
FG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
FG005
Placebo
Placebo
FG0008 subjectsPatients received treatment
FG0019 subjectsPatients received treatment
FG00212 subjectsPatients received treatment
FG00310 subjectsPatients received treatment
FG0048 subjectsPatients received treatment
FG00523 subjectsPatients received treatment
COMPLETED
FG0008 subjectsPatient completed the study drug
FG0018 subjectsPatient completed the study drug
FG0027 subjectsPatient completed the study drug
FG0039 subjectsPatient completed the study drug
FG0047 subjectsPatient completed the study drug
FG00520 subjectsPatient completed the study drug
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0025 subjects
FG0031 subjects
FG0041 subjects
FG0053 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
Death
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Sepsis resolved
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Transferred out of Intensive Care Unit
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Physician discontinued drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
BG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
BG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
BG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
BG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
BG005
Placebo
Placebo
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG0019
BG00212
BG00310
BG0048
BG00523
BG00670
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Mean
Standard Deviation
Year
Title
Denominators
Categories
Title
Measurements
BG00053± 11.8
BG00149.7± 15
BG00255.1± 10.8
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0014
BG002
Mechanical ventilation
Number
Participants
Title
Denominators
Categories
Yes
Title
Measurements
BG0007
BG0018
BG002
Organ failure site
Number
Participants
Title
Denominators
Categories
Cardiovascular
Title
Measurements
BG0002
BG0012
BG002
Shock
Number
Participants
Title
Denominators
Categories
Yes
Title
Measurements
BG0005
BG0016
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in Creatinine Values
Change in creatinine values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Mean
Full Range
μmol/L
End of study (Day 28)
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
OG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
OG005
Placebo
Placebo
Units
Counts
Participants
OG0005
OG0014
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG000-78.6± -239(-239 to 8)
OG001-196.8± -681(-681 to 0)
OG002-25.1± -126(-126 to 44)
Primary
Change From Baseline in Alanine Aminotransferase Values
Change in alanine aminotransferase values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Mean
Full Range
μkat/L
End of study (Day 28)
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
Primary
Change From Baseline in Aspartate Aminotransferase Values
Change in aspartate aminotransferase values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Mean
Full Range
μkat/L
End of study (Day 28)
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
Primary
Change From Baseline in Bilirubin Values
Change in bilirubin values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Mean
Full Range
μmol/L
End of study (Day 28)
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
Primary
Change From Baseline in Haemoglobin Values
Change in haemoglobin values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Mean
Full Range
g/L
End of study (Day 28)
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
Primary
Change From Baseline in White Blood Cell Values
Change in white blood cell values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Mean
Full Range
10^9 cells/L
End of study (Day 28)
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
Primary
Change From Baseline in Platelet Count Values
Change in platelet count values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Mean
Full Range
10^9/L
End of study (Day 28)
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
Primary
Change From Baseline in Prothrombin Time Values
Change in prothrombin time values from baseline (pre-infusion) to Day 7 [calculated as Day 7 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Mean
Full Range
sec
Day 7
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
OG004
Primary
Change From Baseline in Troponin I
Change in troponin I values from baseline (pre-infusion) to Day 6 [calculated as Day 6 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Mean
Full Range
μg/L
Day 6
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
OG004
Primary
Change From Baseline in QT With Fridericia Correction (QTcF), Where QT is Measured by ECG, and is the Time Interval Between the Start of the Q Wave and the End of the T Wave in the Heart's Electrical Cycle.
Change in QTcF from baseline (pre-infusion) to Day 1 (end of infusion) for Cohorts 1 and 2 [calculated as Day 1 mean minus baseline mean] and Day 5 (end of infusion) for Cohorts 3 to 5 and placebo [calculated as Day 5 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Mean
Full Range
msec
Day 1 (end of infusion) for Cohorts 1 and 2; Day 5 (end of infusion) for Cohorts 3 to 5 and placebo
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
Primary
Change From Baseline in Calculated Mean Arterial Blood Pressure
Change in calculated mean arterial pressure from baseline (pre-infusion) to Day 14 [calculated as Day 14 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Mean
Full Range
mmHg
Day 14
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
Primary
Change From Baseline in Body Weight
Change in body weight from baseline (pre-infusion) to Day 6 [calculated as Day 6 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Mean
Full Range
kg
Day 6
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
OG004
Secondary
28-Day Mortality
The number of patients who had died at Day 28. Safety analysis set (ie all patients who started study drug infusion).
Posted
Number
Participants
End of study (Day 28)
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
OG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
Secondary
Change From Baseline in Sequential Organ Failure Assessment (SOFA) Scores
Change in SOFA (Sequential Organ Failure Assessment) scores from baseline (pre-infusion) to Day 6 [calculated as Day 6 mean minus baseline mean]. The SOFA score is out of a maximum of 24 (units on a scale 0 to 24). The higher the score, the worse the organ system functioning. Safety analysis set (ie all patients who started study drug infusion).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Mean
Full Range
units on a scale (0 to 24)
Day 6
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
Secondary
Area Under the Serum Concentration-time Curve From 0 to 12 Hours (AUC(0-12)) of Single Dose AZD9773 Serum Total Fabs (Cohorts 1 and 2)
AUC(0-12) for single dose AZD9773 serum total Fabs (cohorts 1 and 2). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Geometric Mean
Full Range
μg.h/mL
Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8, and 12h post-(last) infusion]
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
Secondary
Terminal Half-life (t1/2) of Single Dose AZD9773 Serum Total Fabs (Cohorts 1 and 2)
t1/2 of single dose AZD9773 serum total Fabs (cohorts 1 and 2). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Mean
Full Range
Hours
Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8, 12, 24, 48, and 72 h post-(last) infusion]
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
Secondary
Total Apparent Clearance (CL) of Single Dose AZD9773 Serum Total Fabs (Cohorts 1 and 2)
CL of single dose AZD9773 serum total Fabs (cohorts 1 and 2). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Mean
Full Range
mL/min/kg
Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8, 12, 24, 48, and 72 h post-(last) infusion]
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
Secondary
AUC(0-12) of Loading Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)
AUC(0-12) of loading dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Geometric Mean
Full Range
μg.h/mL
Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8 and 12 h post-(last) infusion]
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
Secondary
Maximum (End of Infusion) Serum Concentration (Cinf) of Loading Dose AZD9773 Serum Total Fabs (Cohorts 3,4 and 5)
Cinf of loading dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Geometric Mean
Full Range
μg/mL
Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8 and 12 h post-(last)infusion]
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
Secondary
Time to Reach Cinf (Tmax) of Loading Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)
tmax of loading dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Median
Full Range
Hours
Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8 and 12 h post-(last)infusion]
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
Secondary
AUC(0-12) of Maintenance Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)
AUC(0-12) of maintenance dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Geometric Mean
Full Range
μg.h/mL
PK samples taken pre-dose of Doses 5,7 and 9, then at 0, 0.5, 1, 2, 8 and 12 h post dose 9 infusion
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
Secondary
Cinf of Maintenance Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)
Cinf of maintenance dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Geometric Mean
Full Range
μg/mL
PK samples taken pre-dose of Doses 5,7 and 9, then at 0, 0.5, 1, 2, 8 and 12 h post dose 9 infusion
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
Secondary
Tmax of Maintenance Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)
tmax of maintenance dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Median
Full Range
Hours
PK samples taken pre-dose of Doses 5,7 and 9, then at 0, 0.5, 1, 2, 8 and 12 h post dose 9 infusion
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
Secondary
Number of Patients Below Tumour Necrosis Factor (TNF)-Alpha Limit of Quantification (LOQ) at 24 Hours (n< LOQ)
Number of patients below tumour necrosis factor (TNF)-alpha limit of quantification (LOQ) at 24 hours (n< LOQ) measured by ELISA (LOQ = 1.3 pg/mL). Safety analysis set (ie all patients who started study drug infusion).
Participants analyzed relates to the number of evaluable patients at the specified time point.
Posted
Number
Participants
24 hours
ID
Title
Description
OG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
OG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
OG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
OG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
AZD9773 Cohort 1 (50 Units/kg)
AZD9773: single infusion of 50 units/kg
3
8
8
8
EG001
AZD9773 Cohort 2 (250 Units/kg)
AZD9773: single infusion of 250 units/kg
6
9
8
9
EG002
AZD9773 Cohort 3 (250/50 Units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
7
12
11
12
EG003
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
3
10
7
10
EG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
4
8
7
8
EG005
Placebo
Placebo
13
23
22
23
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Sepsis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected9 at risk
EG0023 events3 affected12 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected23 at risk
Pneumonia
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected12 at risk
EG003
Septic Shock
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Empyema
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected12 at risk
EG003
Endocarditis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Cardiac Arrest
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Acute Myocardial Infarction
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Cardiac Failure
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected12 at risk
EG003
Supraventricular Tachycardia
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Pneumonia Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA 12.0
EG0000 events0 affected8 at risk
EG0010 events0 affected9 at risk
EG0022 events1 affected12 at risk
EG003
Shock
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected12 at risk
EG003
Shock Haemorrhagic
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected12 at risk
EG003
Peripheral Ischaemia
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected12 at risk
EG003
Enterocutaneous Fistula
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Intestinal Ischaemia
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Intestinal Perforation
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Medical Device Complication
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Acidosis
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Lung Neoplasm Malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Cerebral Infarction
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected12 at risk
EG003
Haemorrhage Intracranial
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Toxic Epidermal Necrolysis
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Muscle Haemorrhage
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0013 events3 affected9 at risk
EG0022 events2 affected12 at risk
EG0031 events1 affected10 at risk
EG0043 events2 affected8 at risk
EG0054 events4 affected23 at risk
Hypercoagulation
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Leucocytosis
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 12.0
EG0001 events1 affected8 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected12 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected12 at risk
EG003
Heparin-Induced Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Thrombocythaemia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected12 at risk
EG003
Atrial Flutter
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Bundle Branch Block Right
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Supraventricular Tachycardia
Cardiac disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Ventricular Tachycardia
Cardiac disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Adrenal Insufficiency
Endocrine disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Scleral Haemorrhage
Eye disorders
MedDRA (12.0)
Systematic Assessment
EG0002 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Scleral Oedema
Eye disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Abdominal Compartment Syndrome
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0002 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Gastric Ulcer
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected9 at risk
EG0021 affected12 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0002 affected8 at risk
EG0012 affected9 at risk
EG0022 affected12 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Gastrointestinal Motility Disorder
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Intestinal Ischaemia
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Rectal Haemorrhage
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Salivary Hypersecretion
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0002 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
General Oedema
General disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0023 affected12 at risk
EG003
Asthenia
General disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Hypothermia
General disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0022 affected12 at risk
EG003
Oedema Periheral
General disorders
MedDRA (12.0)
Systematic Assessment
EG0002 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Chest Pain
General disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Chills
General disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Face Oedema
General disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0022 affected12 at risk
EG003
Multi-Organ Failure
General disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Pain
General disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Pyrexia
General disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Ischaemic Hepatitis
Hepatobiliary disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Enterobacter Pneumonia
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Infected Skin Ulcer
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Pelvic Abscess
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Systemic Candida
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Tracheobronchitis
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Urinary Tract Infection Enterococcal
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Candiduria
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Central Line Infection
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Clostridial Infection
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Clostridium Difficile Colitis
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0021 affected12 at risk
EG003
Escherichia Urinary Tract Infection
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Fungal Skin Infection
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected9 at risk
EG0021 affected12 at risk
EG003
Gangrene
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Herpes Simplex
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Lung Infection Pseudomonal
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Oral Herpes
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Pneumonia Bacterial
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Pneumonia Escherichia
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Pneumonia Staphylococcal
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Vulvovaginal Mycotic Infection
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Bloody Airway Discharge
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Procedural Hypotension
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Endotracheal Intubation Complication
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Gastrointestinal Stoma Complication
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Airway Peak Pressure Increased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Blood Albumin Decreased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Blood Alkaline Phosphatase Decreased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Blood Phosphorus Decreased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Blood Sodium Decreased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Blood Creatine Phosphokinase Increased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Blood Lactate Dehydrogenase Increased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Brain Natriuretic Peptide Increased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Breath Sounds Abnormal
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0021 affected12 at risk
EG003
Clostridium Difficile Toxin Test Positive
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Ejection Fraction Decreased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Fibrin D Dimer Increased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Haemoglobin Decreased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Hepatic Enzyme Increased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Oxygen Saturation Decreased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Troponin Increased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Urinary Sediment Present
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Urine Output Decreased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected9 at risk
EG0021 affected12 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (12.0)
Systematic Assessment
EG0002 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Feeding Disorder
Metabolism and nutrition disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0012 affected9 at risk
EG0020 affected12 at risk
EG003
Fluid Overload
Metabolism and nutrition disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected9 at risk
EG0020 affected12 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (12.0)
Systematic Assessment
EG0002 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0022 affected12 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Lactic Acidosis
Metabolism and nutrition disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Metabolic Acidosis
Metabolism and nutrition disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Aphasia
Nervous system disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Convulsion
Nervous system disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Depressed Level Of Consciousness
Nervous system disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Headache
Nervous system disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Unresponsive To Stimuli
Nervous system disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Agitation
Psychiatric disorders
MedDRA (12.0)
Systematic Assessment
EG0002 affected8 at risk
EG0012 affected9 at risk
EG0021 affected12 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0022 affected12 at risk
EG003
Confusional State
Psychiatric disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Depression
Psychiatric disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0012 affected9 at risk
EG0020 affected12 at risk
EG003
Mental Status Changes
Psychiatric disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Renal Failure Acute
Renal and urinary disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Renal Failure
Renal and urinary disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Renal Impairment
Renal and urinary disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Scrotal Oedema
Reproductive system and breast disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Lung Disorder
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Pulmonary Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Pulmonary Oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected9 at risk
EG0021 affected12 at risk
EG003
Respiratory Alkalosis
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Respiratory Distress
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Rhonchi
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected9 at risk
EG0021 affected12 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0012 affected9 at risk
EG0020 affected12 at risk
EG003
Decubitus Ulcer
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Drug Eruption
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Skin Discolouration
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Skin Disorder
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0021 affected12 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Periorbital Oedema
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0021 affected12 at risk
EG003
Hypertension
Vascular disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0020 affected12 at risk
EG003
Hypotension
Vascular disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected9 at risk
EG0022 affected12 at risk
EG003
Peripheral Coldness
Vascular disorders
MedDRA (12.0)
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
LTE60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Justin Lindemann
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com
ID
Term
D018805
Sepsis
D012772
Shock, Septic
D018746
Systemic Inflammatory Response Syndrome
Ancestor Terms
ID
Term
D007239
Infections
D007249
Inflammation
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
D012769
Shock
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C587873
AZD9773
C513813
CytoFab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0051 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0051 subjects
53
± 17.9
BG00463.5± 16.1
BG00558.9± 17.4
BG00656.1± 15.5
7
BG0037
BG0046
BG00512
BG00638
Male
BG0006
BG0015
BG0025
BG0033
BG0042
BG00511
BG00632
9
BG0038
BG0048
BG00520
BG00660
No
Title
Measurements
BG0001
BG0010
BG0022
BG0031
BG0040
BG0053
BG0067
Missing
Title
Measurements
BG0000
BG0011
BG0021
BG0031
BG0040
BG0050
BG0063
3
BG0033
BG0042
BG0057
BG00619
Pulmonary dysfunction
Title
Measurements
BG0002
BG0012
BG0023
BG0031
BG0042
BG0053
BG00613
Cardiovascular and pulmonary dysfunction
Title
Measurements
BG0004
BG0015
BG0026
BG0036
BG0044
BG00513
BG00638
9
BG0039
BG0047
BG00520
BG00656
No
Title
Measurements
BG0003
BG0013
BG0023
BG0031
BG0041
BG0053
BG00614
8
OG0046
OG00515
OG003-10.9± -68(-68 to 167)
OG004159.0± -89(-89 to 1087)
OG005-57.4± -191(-191 to 18)
OG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
OG005
Placebo
Placebo
Units
Counts
Participants
OG0005
OG0013
OG0027
OG0037
OG0046
OG00515
Title
Denominators
Categories
Title
Measurements
OG000-0.998± -3.24(-3.24 to 0.16)
OG0010.017± -0.25(-0.25 to 0.43)
OG002-3.133± -20.62(-20.62 to -0.03)
OG003-0.520± -2.05(-2.05 to 0)
OG004-0.825± -4.53(-4.53 to 0.38)
OG005-0.111± -0.79(-0.79 to 0.20)
OG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
OG005
Placebo
Placebo
Units
Counts
Participants
OG0005
OG0013
OG0027
OG0037
OG0046
OG00515
Title
Denominators
Categories
Title
Measurements
OG000-2.298± -5.56(-5.56 to -0.04)
OG001-0.213± -0.43(-0.43 to 0.15)
OG002-3.647± -21.36(-21.36 to -0.02)
OG003-0.926± -3.27(-3.27 to 0.20)
OG004-0.998± -3.29(-3.29 to 0.11)
OG005-0.253± -1.54(-1.54 to 0.15)
OG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
OG005
Placebo
Placebo
Units
Counts
Participants
OG0005
OG0013
OG0027
OG0037
OG0046
OG00515
Title
Denominators
Categories
Title
Measurements
OG000-11.30± -17.1(-17.1 to -5.2)
OG001-13.10± -34.2(-34.2 to 0)
OG002-10.04± -49.6(-49.6 to 0)
OG003-23.71± -71.8(-71.8 to 0)
OG004-2.58± -29.1(-29.1 to 30.8)
OG005-10.00± -37.6(-37.6 to 4.2)
OG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
OG005
Placebo
Placebo
Units
Counts
Participants
OG0005
OG0014
OG0026
OG0034
OG0045
OG00513
Title
Denominators
Categories
Title
Measurements
OG0007± -18(-18 to 31)
OG001-16.3± -42(-42 to 21)
OG002-0.8± -31(-31 to 33)
OG0036.5± -5(-5 to 17)
OG004-13.8± -35(-35 to 4)
OG005-4.5± -47(-47 to 32)
OG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
OG005
Placebo
Placebo
Units
Counts
Participants
OG0005
OG0014
OG0026
OG0034
OG0045
OG00513
Title
Denominators
Categories
Title
Measurements
OG000-17.552± -46.67(-46.67 to -6.11)
OG001-8.975± -22.58(-22.58 to 2.18)
OG0020.413± -8.11(-8.11 to 14.84)
OG003-0.225± -5.60(-5.60 to 2.86)
OG004-3.482± -13.42(-13.42 to 5.82)
OG005-9.987± -26.40(-26.40 to 3.34)
OG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
OG005
Placebo
Placebo
Units
Counts
Participants
OG0005
OG0013
OG0025
OG0034
OG0044
OG00513
Title
Denominators
Categories
Title
Measurements
OG000287± -41(-41 to 650)
OG001117.3± 18(18 to 176)
OG002162± -56(-56 to 474)
OG00372.3± -114(-114 to 159)
OG004252.5± 40(40 to 591)
OG005145.1± -232(-232 to 735)
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
OG005
Placebo
Placebo
Units
Counts
Participants
OG0005
OG0014
OG0026
OG0037
OG0045
OG00517
Title
Denominators
Categories
Title
Measurements
OG000-3.20± -8.6(-8.6 to 2.2)
OG0010.53± -0.8(-0.8 to 2.2)
OG002-1.00± -2.4(-2.4 to 0)
OG003-5.31± -14.7(-14.7 to 0.4)
OG0044.36± -23.8(-23.8 to 49.4)
OG0051.68± -7.5(-7.5 to 32)
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
OG005
Placebo
Placebo
Units
Counts
Participants
OG0008
OG0013
OG0024
OG0039
OG0043
OG00519
Title
Denominators
Categories
Title
Measurements
OG000-16.454± -127.37(-127.37 to 0.26)
OG001-9.523± -28.58(-28.58 to 0.01)
OG002-0.630± -1.61(-1.61 to 0.10)
OG003-1.434± -7.21(-7.21 to 0.04)
OG004-0.027± -0.07(-0.07 to 0)
OG005-0.735± -6.77(-6.77 to 3.68)
AZD9773 Cohort 4 (500/100 Units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
OG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
OG005
Placebo
Placebo
Units
Counts
Participants
OG0007
OG0019
OG0026
OG0039
OG0046
OG00513
Title
Denominators
Categories
Title
Measurements
OG000-9.9± -37(-37 to 9)
OG0013.6± -35(-35 to 63)
OG002-21.5± -43(-43 to -1)
OG003-9.2± -47(-47 to 44)
OG00421.4± -32(-32 to 66)
OG005-3.4± -61(-61 to 29)
OG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
OG005
Placebo
Placebo
Units
Counts
Participants
OG0003
OG0016
OG0024
OG0036
OG0045
OG00511
Title
Denominators
Categories
Title
Measurements
OG00020± 3(3 to 32)
OG0017.3± 2(2 to 13)
OG0025.3± -19(-19 to 34)
OG00328.7± 4(4 to 65)
OG0046.8± -9(-9 to 22)
OG00518± -4(-4 to 44)
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
OG005
Placebo
Placebo
Units
Counts
Participants
OG0007
OG0016
OG0023
OG0035
OG0045
OG00512
Title
Denominators
Categories
Title
Measurements
OG0001.3± -2(-2 to 9)
OG0010.2± -7(-7 to 10)
OG0024± 1(1 to 8)
OG0037.4± -10(-10 to 25)
OG0040.2± -11(-11 to 14)
OG0059.9± 0(0 to 35)
OG005
Placebo
Placebo
Units
Counts
Participants
OG0008
OG0019
OG00212
OG00310
OG0048
OG00523
Title
Denominators
Categories
Title
Measurements
OG0002
OG0014
OG0025
OG0031
OG0041
OG0056
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
OG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
OG005
Placebo
Placebo
Units
Counts
Participants
OG0002
OG0013
OG0023
OG0036
OG0043
OG0059
Title
Denominators
Categories
Title
Measurements
OG000-6± -7(-7 to -5)
OG001-2± -5(-5 to 0)
OG002-3.3± -5(-5 to -2)
OG003-3± -7(-7 to 7)
OG004-6± -11(-11 to -2)
OG005-4.3± -8(-8 to 2)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
OG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
OG005
Placebo
Placebo
Units
Counts
Participants
OG0007
OG0018
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG000125.22(68.6 to 545.3)
OG001581.01(197.6 to 1561.8)
OG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
OG005
Placebo
Placebo
Units
Counts
Participants
OG0007
OG0016
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG00017.97± 7.8(7.8 to 30.1)
OG00119.76± 10.5(10.5 to 25.6)
OG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
OG005
Placebo
Placebo
Units
Counts
Participants
OG0007
OG0016
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG0006.11± 1.2(1.2 to 11.5)
OG0017.61± 0.8(0.8 to 16.7)
OG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
OG005
Placebo
Placebo
Units
Counts
Participants
OG0000
OG0010
OG0028
OG0039
OG0045
OG0050
Title
Denominators
Categories
Title
Measurements
OG002449.18(230.2 to 828.8)
OG003691.53(474.6 to 1024.7)
OG0041872.73(1391.2 to 2559)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
OG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
OG005
Placebo
Placebo
Units
Counts
Participants
OG0000
OG0010
OG0028
OG0039
OG0045
OG0050
Title
Denominators
Categories
Title
Measurements
OG002107.84(72.3 to 197)
OG003160.09(130 to 208)
OG004351.52(286 to 443)
OG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
OG005
Placebo
Placebo
Units
Counts
Participants
OG0000
OG0010
OG0028
OG0039
OG0045
OG0050
Title
Denominators
Categories
Title
Measurements
OG0020.92(0.5 to 1.4)
OG0031.08(0.9 to 1.7)
OG0041.12(1.1 to 1.3)
OG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
OG005
Placebo
Placebo
Units
Counts
Participants
OG0000
OG0010
OG0026
OG0037
OG0044
OG0050
Title
Denominators
Categories
Title
Measurements
OG002162.82(66.3 to 440.4)
OG003251.59(102.4 to 531.7)
OG004980.95(646 to 1524.2)
OG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
OG005
Placebo
Placebo
Units
Counts
Participants
OG0000
OG0010
OG0026
OG0037
OG0044
OG0050
Title
Denominators
Categories
Title
Measurements
OG00228.37(14.6 to 58.4)
OG00342.51(8.9 to 71.1)
OG004151.76(129 to 184)
OG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
OG005
Placebo
Placebo
Units
Counts
Participants
OG0000
OG0010
OG0026
OG0037
OG0044
OG0050
Title
Denominators
Categories
Title
Measurements
OG0020.54(0.0 to 0.7)
OG0031.00(0.4 to 8.5)
OG0040.74(0.5 to 1.6)
OG004
AZD9773 Cohort 5 (750/250 Units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs