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Effects of the V1a Agonist FE 202158 in Patients With Septic Shock

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ClinicalTrials.gov Identifier: NCT01000649
Recruitment Status : Completed
First Posted : October 23, 2009
Results First Posted : June 2, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Septic Shock
Interventions Drug: FE 202158 1.25
Drug: FE 202158 2.5
Drug: FE 202158 3.75
Other: Placebo
Enrollment 53
Recruitment Details Total 55 patients were screened and 53 were randomized. One patient randomized to placebo died before dosing, and one patient randomized to 2.5 ng/kg/min was erroneously dosed with placebo.
Pre-assignment Details  
Arm/Group Title FE 202158 1.25 FE 202158 2.5 FE 202158 3.75 PLCBO
Hide Arm/Group Description

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 3.75 ng/kg/min.The two patients randomized to FE 202158 3.75 ng group were excluded from the efficacy evaluation since meaningful analyses were not possible.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Period Title: Overall Study
Started 10 [1] 19 [1] 2 [1] 21 [1]
Intention-to-Treat (ITT) Analysis Set 10 [2] 20 [2] 2 [2] 21 [2]
Completed 5 16 0 15
Not Completed 5 3 2 6
Reason Not Completed
Adverse Event             5             1             2             4
Lost to Follow-up             0             2             0             2
[1]
This represents Full Analysis Set population, which comprised of all dosed patients.
[2]
ITT population comprised of all randomized patients.
Arm/Group Title FE 202158 1.25 FE 202158 2.5 FE 202158 3.75 PLCBO Total
Hide Arm/Group Description

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 3.75 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo. Total of all reporting groups
Overall Number of Baseline Participants 10 19 2 21 52
Hide Baseline Analysis Population Description
Analysis population consist of FAS.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 19 participants 2 participants 21 participants 52 participants
59.3  (19.6) 57.1  (15.4) 69  (12.7) 63.2  (18) 60.4  (17.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 19 participants 2 participants 21 participants 52 participants
Female
7
  70.0%
9
  47.4%
1
  50.0%
6
  28.6%
23
  44.2%
Male
3
  30.0%
10
  52.6%
1
  50.0%
15
  71.4%
29
  55.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 19 participants 2 participants 21 participants 52 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.8%
1
   1.9%
Not Hispanic or Latino
10
 100.0%
19
 100.0%
2
 100.0%
20
  95.2%
51
  98.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 19 participants 2 participants 21 participants 52 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   5.3%
0
   0.0%
1
   4.8%
2
   3.8%
White
10
 100.0%
18
  94.7%
2
 100.0%
20
  95.2%
50
  96.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 10 participants 19 participants 2 participants 21 participants 52 participants
64.8  (14.3) 87.6  (28.6) 77.5  (17.7) 75.1  (15.3) 77.8  (22.2)
Sequential Organ Failure Assessment (SOFA) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 10 participants 19 participants 2 participants 21 participants 52 participants
9.3  (2.16) 11.2  (3.73) 12  (0) 10.4  (3.46) 10.5  (3.31)
[1]
Measure Description:

The SOFA score, is used to track a patient’s status during the stay in an intensive care unit. This scoring system is used to determine the extent of a person’s organ function or rate of failure. The scoring system comprise of scores for six different system: Respiratory System; Nervous System; Cardiovascular System; Liver; Coagulation; and Renal System. Score for each system ranges from 0-4 (0=normal, 4=worst)..

Total SOFA score is a sum of the individual system score and range from 0 to 24, 0 being the better and 24 being the worst patient status.

1.Primary Outcome
Title Proportion of Patients Maintaining Target Mean Arterial Pressure (MAP) (>60 mmHg) With no Open Label NE (Norepinephrine)
Hide Description

Data were evaluated for target MAP of ≥ 60 mmHg. A 95% confidence interval (CI) was calculated and presented using Clopper-Pearson method.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame Day 1 up to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of Full Analysis Set, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5 PLCBO
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Overall Number of Participants Analyzed 10 19 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
Day 1 - 12 hrs
0.0
(0.0 to 30.8)
47.1
(23.0 to 72.2)
0.0
(0.0 to 16.8)
Day 1 - 24 hrs
10.0
(0.3 to 44.5)
68.8
(41.3 to 89.0)
20.0
(5.7 to 43.7)
Day 2 - 48 hrs
55.6
(21.2 to 86.3)
66.7
(38.4 to 88.2)
38.9
(17.3 to 64.3)
Day 4 - 96 hrs
75.0
(34.9 to 96.8)
66.7
(29.9 to 92.5)
70.6
(44.0 to 89.7)
Day 7 - 168 hrs
62.5
(24.5 to 91.5)
80.0
(44.4 to 97.5)
100.0
(78.2 to 100.0)
2.Primary Outcome
Title Proportion of Patients Maintaining Target MAP (>60) Irrespective of Open Label NE
Hide Description

Data were evaluated for target MAP of ≥ 60 mmHg. A 95% confidence interval (CI) was calculated and presented using Clopper-Pearson method.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame Day 1 up to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of Full Analysis Set, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5 PLCBO
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Overall Number of Participants Analyzed 10 19 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
Day 1 - 12 hrs
100.0
(63.1 to 100.0)
100.0
(80.5 to 100.0)
94.7
(74.0 to 99.9)
Day 1 - 24 hrs
87.5
(47.3 to 99.7)
100.0
(78.2 to 100.0)
100.0
(83.2 to 100.0)
Day 2 - 48 hrs
100.0
(66.4 to 100.0)
100.0
(76.8 to 100.0)
100.0
(81.5 to 100.0)
Day 4 - 96 hrs
100.0
(63.1 to 100.0)
100.0
(63.1 to 100.0)
100.0
(80.5 to 100.0)
Day 7 - 168 hrs
62.5
(24.5 to 91.5)
100.0
(66.4 to 100.0)
100.0
(78.2 to 100.0)
3.Primary Outcome
Title Cumulative Dose of Open Label NE.
Hide Description

Cumulative Dose of Open Label NE over 7 days.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame Day 1 up to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of Full Analysis Set, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5 PLCBO
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Overall Number of Participants Analyzed 10 19 21
Mean (Standard Deviation)
Unit of Measure: µg/kg
Day 1 - 1 hour 14.3  (11.6) 13.1  (12.6) 19.2  (14.6)
Day 1 - 3 hours 40.5  (35) 30  (33.1) 57.2  (44)
Day 1 - 6 hours 75.8  (60.4) 46.9  (59.4) 110  (84)
Day 1 - 12 hours 130  (96.3) 66.5  (102) 206  (159)
Day 1 - 24 hours 211  (147) 101  (193) 360  (270)
Day 2 - 36 hours 282  (206) 122  (253) 477  (363)
Day 2 - 48 hours 349  (303) 138  (297) 554  (445)
Day 3 - 60 hours 389  (377) 150  (334) 606  (509)
Day 3 - 72 hours 420  (432) 160  (364) 646  (567)
Day 4 - 84 hours 443  (471) 169  (395) 680  (623)
Day 4 - 96 hours 465  (507) 179  (430) 707  (674)
Day 5 - 108 hours 349  (342) 186  (452) 728  (713)
Day 5 - 120 hours 374  (410) 193  (467) 749  (757)
Day 6 - 132 hours 404  (474) 200  (495) 767  (793)
Day 6 - 144 hours 421  (519) 217  (563) 782  (823)
Day 7 - 156 hours 444  (582) 236  (643) 798  (853)
Day 7 - 168 hours 477  (673) 245  (678) 824  (897)
4.Primary Outcome
Title Infusion Rates of Open Label NE.
Hide Description

Mean open label NE infusion rate within each predefined time period.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame Day 1 up to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of FAS, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5 PLCBO
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Overall Number of Participants Analyzed 10 19 21
Mean (Standard Deviation)
Unit of Measure: µg/kg/min
Day 1 - 1 hour 0.24  (0.19) 0.22  (0.21) 0.32  (0.24)
Day 1 - 3 hours 0.22  (0.19) 0.11  (0.17) 0.31  (0.24)
Day 1 - 6 hours 0.18  (0.15) 0.09  (0.15) 0.28  (0.22)
Day 1 - 12 hours 0.13  (0.11) 0.06  (0.14) 0.26  (0.20)
Day 1 - 24 hours 0.09  (0.08) 0.04  (0.11) 0.19  (0.17)
Day 2 - 36 hours 0.10  (0.12) 0.02  (0.07) 0.13  (0.14)
Day 2 - 48 hours 0.08  (0.16) 0.02  (0.06) 0.08  (0.13)
Day 3 - 60 hours 0.03  (0.05) 0.02  (0.06) 0.07  (0.11)
Day 3 - 72 hours 0.04  (0.08) 0.01  (0.04) 0.05  (0.10)
Day 4 - 84 hours 0.03  (0.07) 0.02  (0.06) 0.04  (0.11)
Day 4 - 96 hours 0.03  (0.07) 0.01  (0.05) 0.03  (0.10)
Day 5 - 108 hours 0.0  (0.0) 0.01  (0.01) 0.04  (0.08)
Day 5 - 120 hours 0.02  (0.07) 0.01  (0.04) 0.03  (0.07)
Day 6 - 132 hours 0.02  (0.05) 0.01  (0.04) 0.02  (0.06)
Day 6 - 144 hours 0.03  (0.08) 0.03  (0.13) 0.02  (0.06)
Day 7 - 156 hours 0.04  (0.12) 0.02  (0.08) 0.02  (0.06)
Day 7 - 168 hours 0.05  (0.15) 0.02  (0.05) 0.01  (0.03)
5.Secondary Outcome
Title Pharmacokinetic (PK) Parameter in Patients : Steady State Concentration
Hide Description

PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame Day 1 up to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of FAS, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Overall Number of Participants Analyzed 10 17
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.50  (0.13) 0.99  (0.32)
6.Secondary Outcome
Title PK Parameter in Patients : Time to Steady State
Hide Description

PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame Day 1 up to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of FAS, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Overall Number of Participants Analyzed 10 17
Mean (Standard Deviation)
Unit of Measure: Hour
7.6  (2.8) 7.0  (2.3)
7.Secondary Outcome
Title PK Parameter in Patients : Clearance
Hide Description

PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame Day 1 up to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of FAS, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Overall Number of Participants Analyzed 10 17
Mean (Standard Deviation)
Unit of Measure: Litre/hour
10.0  (2.8) 13.1  (2.9)
8.Secondary Outcome
Title PK Parameter in Patients : Steady State Volume of Distribution
Hide Description

PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame Day 1 up to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of FAS, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Overall Number of Participants Analyzed 10 17
Mean (Standard Deviation)
Unit of Measure: Litre
25.5  (10.6) 31.2  (14.7)
9.Secondary Outcome
Title PK Parameter in Patients : Initial Elimination Half-life
Hide Description

PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame Day 1 up to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of FAS, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Overall Number of Participants Analyzed 10 17
Mean (Standard Deviation)
Unit of Measure: Hour
0.18  (0.09) 0.17  (0.06)
10.Secondary Outcome
Title PK Parameter in Patients : Terminal Elimination Half-life
Hide Description

PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame Day 1 up to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of FAS, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Overall Number of Participants Analyzed 10 17
Mean (Standard Deviation)
Unit of Measure: Hour
2.5  (1.1) 2.7  (1.2)
11.Secondary Outcome
Title Change From Baseline in C-reactive Protein (CRP)
Hide Description

The change from Baseline in CRP levels were analysed and presented as per the planned time points.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame Day 1 up to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of FAS, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5 PLCBO
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Overall Number of Participants Analyzed 10 19 21
Mean (Standard Deviation)
Unit of Measure: mg/L
Day 1 (0-24 hours) 9.81  (42.2) -4.84  (38.5) 32.7  (63.8)
Day 2 (24-48 hours) -16.2  (89.4) -52.4  (70.1) -5.63  (118)
Day 4 (72-96 hours) -95.8  (97.1) -176  (208) -71.8  (97.5)
Day 7 (144-168 hours) -93.3  (58) -211.0  (223) -141  (221)
12.Secondary Outcome
Title Change From Baseline in Tumor Necrosis Factor (TNF)-Alpha
Hide Description

The change from Baseline in TNF-alpha levels were analysed and presented as per the planned time points.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame At Day 1, Day 2, Day 4, and Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of FAS, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5 PLCBO
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Overall Number of Participants Analyzed 10 19 21
Mean (Standard Deviation)
Unit of Measure: ng/L
Day 1 (0-24 hours) -0.75  (2.37) -0.194  (0.825) -0.125  (0.559)
Day 2 (24-48 hours) -0.75  (2.37) 0.0  (0.0) 0.0  (0.0)
Day 4 (72-96 hours) -0.833  (2.5) 0.75  (3.0) -0.125  (0.559)
Day 7 (144-168 hours) -1.25  (3.06) 1.14  (4.28) 0.25  (0.845)
13.Secondary Outcome
Title Change From Baseline in Interleukin-6 (IL-6)
Hide Description

The change from Baseline in IL-6 levels were analysed and presented as per the planned time points.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame At Day 1, Day 2, Day 4, and Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of FAS, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5 PLCBO
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Overall Number of Participants Analyzed 10 19 21
Mean (Standard Deviation)
Unit of Measure: ng/L
Day 1 (0-24 hours) -329  (736) -524  (2255) -529  (1750)
Day 2 (24-48 hours) -720  (1178) -888  (1798) -398  (2101)
Day 4 (72-96 hours) -794  (1206) -1209  (1844) -1140  (1944)
Day 7 (144-168 hours) -883  (1559) -1184  (1801) -814  (1823)
14.Secondary Outcome
Title Change From Baseline in Interleukin-10 (IL-10)
Hide Description

The change from Baseline in IL-10 levels were analysed and presented as per the planned time points.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame At Day 1, Day 2, Day 4, and Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of FAS, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5 PLCBO
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Overall Number of Participants Analyzed 10 19 21
Mean (Standard Deviation)
Unit of Measure: ng/L
Day 1 (0-24 hours) -19.2  (54.6) -58.3  (179) -25.8  (51.7)
Day 2 (24-48 hours) -34  (70.4) -78.9  (189) -43  (76.1)
Day 4 (72-96 hours) -31.9  (95.2) -92.3  (213) -56.6  (84.5)
Day 7 (144-168 hours) 8  (24.3) -91.7  (220) -52.8  (97.1)
15.Secondary Outcome
Title Change From Baseline in Interleukin-1 Receptor (IL-1R) Antagonist
Hide Description

The change from Baseline in IL-1R levels were analysed and presented as per the planned time points.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame At Day 1, Day 2, Day 4, and Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of FAS, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5 PLCBO
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Overall Number of Participants Analyzed 10 19 21
Mean (Standard Deviation)
Unit of Measure: µg/L
Day 1 (0-24 hours) 0.763  (5.39) -3.71  (7.61) -3.28  (5.79)
Day 2 (24-48 hours) -3.65  (9.89) -4.77  (10.7) -3.84  (7.86)
Day 4 (72-96 hours) -6.38  (12) -6.44  (12) -4.51  (8.63)
Day 7 (144-168 hours) -3.5  (5.72) -5.3  (10.4) -3.9  (8.35)
16.Secondary Outcome
Title Change From Baseline in Heart Rate
Hide Description

The change from Baseline in heart rate was analysed and presented as per the planned time points.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame Day 1 up to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of Safety Analysis Set, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5 PLCBO
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Overall Number of Participants Analyzed 10 19 21
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Day 1 - 3 hours -5.7  (8.06) -11.0  (14.1) -4.9  (14.3)
Day 1 - 6 hours -4.9  (6.06) -11.9  (14.9) -6.55  (13.1)
Day 1 - 9 hours -7.2  (7.02) -11.6  (17.3) -5.35  (17.7)
Day 1 - 12 hours -7.6  (10.4) -11.5  (13.8) -8.45  (16.3)
Day 1 - 15 hours -8.6  (7.76) -13.2  (15.5) -4.5  (18.5)
Day 1 - 18 hours -7.22  (9.58) -6.26  (19.1) -6.95  (18.8)
Day 1 - 21 hours -10  (9.31) -9.79  (14.8) -3.2  (22.9)
Day 1 - 24 hours -7.44  (17.9) -2.95  (25.1) -2.37  (29.4)
Day 2 - 27 hours -7.6  (14.5) -9.16  (19.3) -5.4  (27.9)
Day 2 - 30 hours -10.3  (14.4) -13.1  (17.4) -7.35  (22.9)
Day 2 - 33 hours -9.3  (13.9) -11.1  (15) -10.5  (22.2)
Day 2 - 36 hours -6.9  (15.5) -9.47  (16.0) -9.05  (26.7)
Day 2 - 39 hours -6.7  (12.8) -9.21  (18.4) -7.2  (25.7)
Day 2 - 42 hours -6  (12.4) -11.3  (16.5) -9.5  (24.4)
Day 2 - 45 hours -1.9  (8.91) -9.11  (14.1) -6.5  (28.1)
Day 2 - 48 hours -9.9  (13.8) -7.39  (13) -8.9  (25)
Day 3 - 51 hours -10.2  (8.53) -8.06  (16.7) -9.11  (27.9)
Day 3 - 54 hours -6.11  (10.1) -10.5  (18.1) -9.94  (27)
Day 3 - 57 hours -3.67  (10.4) -6.87  (21.8) -7.94  (28.6)
Day 3 - 60 hours -1.6  (7.96) -8.25  (22.3) -9.4  (25.5)
Day 3 - 63 hours -6.78  (10.6) -10.3  (22.6) -10.6  (24.7)
Day 3 - 66 hours -5.11  (10.9) -9.63  (19.4) -10.9  (25)
Day 3 - 69 hours -9.44  (11.9) -4.64  (24.6) -8.35  (26.2)
Day 3 - 72 hours -11.9  (10.5) -10.7  (19.8) -8.41  (28.7)
Day 4 - 78 hours -2.11  (20.9) -10.1  (18.9) -7.06  (29.7)
Day 4 - 84 hours -2.4  (16.8) -12.5  (17.6) -9.5  (27)
Day 4 - 90 hours -7.38  (15.3) -10.6  (19.2) -4.18  (31.0)
Day 4 - 96 hours -2.56  (22.3) -12.2  (16.1) -7.78  (28)
Day 5 - 102 hours 4.63  (23.2) -9.38  (19.8) -9.65  (28.4)
Day 5 - 108 hours 2.11  (15.7) -10.5  (15.9) -6.05  (27.8)
Day 5 - 114 hours 1.25  (18.9) -10.3  (16.7) -6.12  (30.3)
Day 5 - 120 hours 4.11  (18.1) -7.15  (17.4) -5.06  (28.1)
Day 6 - 126 hours -0.714  (13) -5.79  (20.2) -4.19  (24.4)
Day 6 - 132 hours 1.13  (14.8) -9.93  (16.7) -4.22  (24.7)
Day 6 - 138 hours -3  (9.92) -10.6  (14.6) -6.4  (23.6)
Day 6 - 144 hours 1.38  (8.19) -10.7  (17.3) 1.28  (18.6)
Day 7 - 150 hours 0.2  (13.4) -6  (22.3) -1.88  (28.2)
Day 7 - 156 hours 6  (20.2) -4.58  (19.9) -8.83  (15.2)
Day 7 - 162 hours 6.33  (22) -3.5  (19.1) -11.5  (15.9)
Day 7 - 168 hours 8.17  (13.7) -6.27  (21.3) -6.94  (15.6)
17.Secondary Outcome
Title Change From Baseline in Fluid Balance
Hide Description

The change from Baseline in fluid balance were analysed and presented as per the planned time points. The fluid balance was adjusted for length of time interval and weight.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame Day 1 up to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of FAS, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5 PLCBO
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Overall Number of Participants Analyzed 10 19 21
Mean (Standard Deviation)
Unit of Measure: mL/hour/kg
Day 1 - 0-6 hours -2.11  (6.99) -0.0513  (3.08) -0.477  (2.03)
Day 1 - 0-12 hours -3.56  (6.34) -0.889  (3.29) -0.578  (2.2)
Day 1 - 12-18 hours -3.66  (6.68) -1.41  (3.11) -0.98  (2.42)
Day 1 - 18-24 hours -3.49  (6.78) -1.47  (3.45) -0.119  (2.95)
Day 2 - 24-30 hours -3.49  (5.56) -1.75  (3.1) -0.905  (2.68)
Day 2 - 30-36 hours -3.42  (5.63) -0.963  (3.82) -1.47  (3.04)
Day 2 - 36-42 hours -3.34  (6.09) -1.82  (3.36) -2.54  (3.48)
Day 2 - 42-48 hours -3.82  (6.66) -2.18  (3.51) -2.01  (3.52)
Day 3 - 48-54 hours -3.2  (6.26) -1.97  (3.68) -1.93  (2.59)
Day 3 - 54-60 hours -4.42  (7.6) -2.85  (3.52) -2.91  (2.55)
Day 3 - 60-66 hours -4.31  (6.68) -2.86  (3.33) -2.21  (2.54)
Day 3 - 66-72 hours -4.64  (6.71) -2.75  (3.76) -2.54  (2.79)
Day 4 - 72-84 hours -4.82  (6.47) -2.52  (3.36) -2.35  (3.28)
Day 4 - 84-96 hours -4.01  (6.08) -2.4  (3.55) -2.67  (3.58)
Day 5 - 96-108 hours -4.3  (6.08) -2.84  (4.08) -2.62  (3.2)
Day 5 - 108-120 hours -4.12  (5.99) -3.3  (3.84) -2.22  (2.78)
Day 6 - 120-132 hours -4.17  (6.19) -3.04  (3.86) -2.67  (3.45)
Day 6 - 132-144 hours -5.41  (6.62) -2.99  (3.17) -2.87  (3.19)
Day 7 - 144-156 hours -5.56  (6.34) -2.37  (3.1) -2.8  (2.69)
Day 7 - 156-168 hours -5.38  (6.09) -2.85  (3.13) -2.6  (2.46)
18.Secondary Outcome
Title SOFA Score
Hide Description

The SOFA score, is used to track a patient's status during the stay in an intensive care unit. This scoring system is used to determine the extent of a person's organ function or rate of failure. The scoring system comprise of scores for six different system: Respiratory System; Nervous System; Cardiovascular System; Liver; Coagulation; and Renal System. Score for each system ranges from 0-4 (0=normal, 4=worst).

Total SOFA score is a sum of the individual system score and range from 0 to 24, 0 being the better and 24 being the worst patient status.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame Day 1 up to Day 7, Day 14 and Day 29
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of FAS, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5 PLCBO
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Overall Number of Participants Analyzed 10 19 21
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Day 1 (0-24 hours) 8.7  (2.45) 11.9  (3.43) 10.5  (3.22)
Day 2 (24-48 hours) 8.0  (3.5) 8.68  (3.07) 9.0  (2.83)
Day 3 (48-72 hours) 7.6  (3.53) 8.32  (3.64) 8.2  (2.57)
Day 4 (72-96 hours) 6.8  (3.91) 7.5  (3.91) 8.05  (2.82)
Day 5 (96-120 hours) 6.6  (4.2) 7.06  (3.49) 7.44  (2.77)
Day 6 (120-144 hours) 5.22  (3.35) 6.63  (3.32) 7.06  (3.02)
Day 7 (144-168 hours) 4.63  (3.7) 5.93  (3.65) 7.18  (2.65)
Day 14 5.0  (4.36) 4.27  (3.82) 3.53  (1.81)
Day 28 1.75  (2.36) 2.7  (2.63) 2.11  (0.93)
19.Secondary Outcome
Title Pulmonary Function : Change From Baseline in PaO2/FiO2
Hide Description

Change from Baseline in PaO2/FiO2 was observed at each time-point.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame Day 1 up to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of Safety Analysis Set, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5 PLCBO
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Overall Number of Participants Analyzed 10 19 21
Mean (Standard Deviation)
Unit of Measure: Ratio
Day 1 - 6 hours -1.7  (80.3) 1.35  (85.2) -7.06  (99.9)
Day 1 - 12 hours 22.8  (95.3) -11.9  (61.9) 7.32  (72.3)
Day 1 - 18 hours 12.1  (86.7) -17.6  (94) 9.21  (88.5)
Day 1 - 24 hours -4.22  (84.4) 34.8  (144) -3.68  (92.8)
Day 2 - 30 hours 54.3  (142) -16.5  (116) 12.4  (96.1)
Day 2 - 36 hours 15.8  (112) 6.89  (115) 39.8  (100)
Day 2 - 42 hours 28.6  (137) -1.27  (118) 14.6  (123)
Day 2 - 48 hours 16.2  (74.3) 10.3  (105) 8.24  (135)
Day 3 - 54 hours 24.8  (137) 49.5  (81.1) 19.4  (129)
Day 3 - 60 hours 118  (172) 9.8  (106) 50  (108)
Day 3 - 66 hours 64.7  (131) 6.38  (70.1) 17.7  (120)
Day 3 - 72 hours 51.7  (120) 74.2  (89.8) 21.8  (119)
Day 4 - 84 hours 61.4  (115) 7.54  (85.4) 44.1  (97.9)
Day 4 - 96 hours 96.1  (97.2) 65.5  (112) 22.9  (128)
Day 5 - 108 hours 123  (233) 30.1  (49.3) 38.4  (115)
Day 5 - 120 hours 63.7  (130) 5.89  (58.3) 51.8  (132)
Day 6 - 132 hours 123  (154) 7.17  (89.6) 40.3  (133)
Day 6 - 144 hours 42.8  (69.3) 30.2  (83.7) -19.6  (114)
Day 7 - 156 hours 37.6  (68.3) 40.9  (83.8) -19.1  (151)
Day 7 - 168 hours 117  (255) 59  (68.1) -30.2  (105)
20.Secondary Outcome
Title Pulmonary Function : Change From Baseline in Tidal Volume
Hide Description

Change from Baseline in tidal volume was observed at each time-point.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame Day 1 up to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of Safety Analysis Set, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5 PLCBO
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Overall Number of Participants Analyzed 10 19 21
Mean (Standard Deviation)
Unit of Measure: mL/kg
Day 1 - 6 hours -0.533  (0.666) 0.196  (0.736) -0.0189  (1.91)
Day 1 - 12 hours -0.208  (0.708) 0.256  (0.794) -0.24  (1.37)
Day 1 - 18 hours 0.171  (0.957) 0.141  (0.539) -0.26  (1.17)
Day 1 - 24 hours -1.1  (1.16) 0.285  (1.02) 0  (1.64)
Day 2 - 30 hours -0.81  (1.15) 0.34  (1.46) -0.0259  (2.11)
Day 2 - 36 hours -0.208  (1.24) 0.145  (0.734) -0.223  (1.64)
Day 2 - 42 hours -0.478  (1.13) 0.298  (1.21) -1.19  (1.33)
Day 2 - 48 hours -0.604  (1.52) 0.532  (1.31) -0.538  (2.02)
Day 3 - 54 hours -0.118  (1.86) 0.163  (1.19) -0.859  (1.84)
Day 3 - 60 hours -0.214  (1.1) 0.62  (1.69) -0.951  (1.57)
Day 3 - 66 hours -0.01  (1.37) 0.628  (1.25) -0.592  (1.98)
Day 3 - 72 hours -0.23  (1.49) 1.48  (3.19) -0.348  (1.78)
Day 4 - 84 hours 0.966  (2.44) 0.466  (1.89) -0.844  (2.03)
Day 4 - 96 hours -0.528  (1.62) -0.313  (0.864) -1.16  (2.44)
Day 5 - 108 hours 0.633  (1.93) 0.207  (1.39) -0.723  (2.14)
Day 5 - 120 hours -0.338  (2.24) -0.412  (0.709) -0.613  (1.73)
Day 6 - 132 hours -0.298  (1.41) 0.462  (1.86) -0.746  (1.41)
Day 6 - 144 hours -0.458  (1.09) 0.292  (2.69) -0.823  (1.71)
Day 7 - 156 hours 0.483  (1.13) -0.733  (1.32) -2.14  (2.53)
Day 7 - 168 hours -0.0667  (1.1) -0.438  (1.37) -2.19  (2.93)
21.Secondary Outcome
Title Change From Baseline in Arterial Blood Gas (Lactate)
Hide Description

Change from Baseline in arterial blood gas (lactate) was observed at each time-point.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame Day 1 up to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of Safety Analysis Set, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5 PLCBO
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Overall Number of Participants Analyzed 10 19 21
Mean (Standard Deviation)
Unit of Measure: mmol/L
Day 1 - 6 hours 0  (0.482) -0.367  (1.03) -0.0278  (0.647)
Day 1 - 12 hours -0.489  (0.857) -0.833  (1.53) -0.0444  (0.912)
Day 1 - 18 hours -0.525  (0.932) -1.01  (1.66) -0.3  (0.974)
Day 1 - 24 hours -0.9  (1.06) -1.01  (1.93) -0.533  (1.13)
Day 2 - 30 hours -0.975  (1.09) -1.33  (2.5) -0.647  (1.12)
Day 2 - 36 hours -0.744  (1.01) -1.45  (2.57) -0.683  (1.19)
Day 2 - 42 hours -0.844  (0.958) -1.57  (2.84) -0.917  (1.11)
Day 2 - 48 hours -0.722  (1.11) -1.68  (2.84) -0.888  (1.29)
Day 3 - 54 hours -0.788  (1.22) -1.6  (1.99) -1.11  (1.33)
Day 3 - 60 hours -0.163  (1.13) -1.15  (1.65) -0.925  (1.4)
Day 3 - 66 hours -0.371  (1.08) -1.01  (1.84) -1.15  (1.39)
Day 3 - 72 hours -0.643  (1.03) -1.27  (1.92) -0.879  (1.45)
Day 4 - 84 hours -0.5  (1.07) -0.975  (1.76) -1.12  (1.36)
Day 4 - 96 hours -0.671  (0.948) -0.52  (0.902) -1.34  (1.47)
Day 5 - 108 hours -0.633  (0.963) -1.37  (2.07) -1.21  (1.51)
Day 5 - 120 hours -0.6  (1) -1.06  (1.89) -1.38  (1.5)
Day 6 - 132 hours -0.717  (0.768) -1.26  (1.87) -1.23  (1.27)
Day 6 - 144 hours -1.03  (1.01) -1.28  (1.84) -1.12  (0.946)
Day 7 - 156 hours -0.56  (0.783) -2.17  (3.44) -1.3  (1.36)
Day 7 - 168 hours -0.533  (2.2) -1.6  (1.92) -1.34  (1.62)
22.Secondary Outcome
Title Days Alive and Free of Any Organ Dysfunction at Day 7
Hide Description

Percentage of days alive and free of any organ dysfunction (i.e. no. of days divided by 7).

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame At Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of FAS, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5 PLCBO
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Overall Number of Participants Analyzed 10 19 21
Mean (Standard Deviation)
Unit of Measure: Percentage of days
5.38  (10.7) 3.8  (11.4) 0.0  (0.0)
23.Secondary Outcome
Title Percentage of Patients Alive and Free of All Vasopressors
Hide Description

Percentage of patients alive and free of all vasopressors was assessed on Days 7, 14, and 28.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame At Day 7, Day 14 and Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of FAS, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5 PLCBO
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Overall Number of Participants Analyzed 10 19 21
Measure Type: Number
Unit of Measure: Percentage of patients
Day 7 60.0 57.9 73.7
Day 14 40.0 89.5 94.7
Day 28 50.0 82.4 83.3
24.Secondary Outcome
Title Percentage of Days Alive and Free of Dialysis
Hide Description

Percentage of days alive and free of dialysis was assessed on Days 7, 14, and 28.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame At Day 7, Day 14 and Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of FAS, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5 PLCBO
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Overall Number of Participants Analyzed 10 19 21
Mean (Standard Deviation)
Unit of Measure: Percentage of days
Day 7 53.9  (43.4) 79.7  (36.4) 83.2  (24.1)
Day 14 55.1  (45.0) 80.1  (33.4) 87.6  (16.9)
Day 28 50.5  (43.9) 78.5  (35.4) 88.6  (19.8)
25.Secondary Outcome
Title Percentage of Days Alive and Free of Ventilation
Hide Description

Percentage of days alive and free of ventilation was assessed on Days 7, 14, and 28.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame At Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of FAS, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5 PLCBO
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Overall Number of Participants Analyzed 10 19 21
Mean (Standard Deviation)
Unit of Measure: Percentage of days
31.3  (37.5) 53.8  (38.9) 23.1  (34.8)
26.Secondary Outcome
Title Mortality
Hide Description

Mortality was assessed as percentage of patients dead at pre-specified time points.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame At Day 1, 7, 14, and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of FAS, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5 PLCBO
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Overall Number of Participants Analyzed 10 19 21
Measure Type: Number
Unit of Measure: Percentage of patients
At Day 1 0.0 0.0 0.0
At Day 7 20.0 0.0 0.0
At Day 14 40.0 0.0 0.0
At Day 28 50.0 5.3 21.1
27.Secondary Outcome
Title Incidence of Abnormal Changes in ECG
Hide Description

The number of patients having abnormal changes in ECG variables during the trial period was presented.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

Time Frame Day 1 up to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consist of Safety Analysis Set, which comprised of all patients who were dosed.
Arm/Group Title FE 202158 1.25 FE 202158 2.5 PLCBO
Hide Arm/Group Description:

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Overall Number of Participants Analyzed 10 19 21
Measure Type: Number
Unit of Measure: Number of patients
Heart rate <=50 beats per minute 0 1 4
Heart rate >=100 beats per minute 5 11 8
PQ interval <=120 msec 1 6 5
PQ interval >=220 msec 0 0 1
QRS interval >=120 msec 2 2 4
QT interval >=450 msec 3 4 8
QT interval >=480 msec 1 2 6
QT interval >=500 msec 0 2 3
QT interval >=30 msec increase from Baseline 7 15 14
QT interval >=60 msec increase from Baseline 5 13 12
QTcF >=450 msec 1 9 10
QTcF >=480 msec 0 3 7
QTcF >=500 msec 0 2 6
QTcF >=30 msec increase from Baseline 3 14 11
QTcF >=60 msec increase from Baseline 2 9 9
Time Frame 28 days
Adverse Event Reporting Description AE information was collected throughout the trial from the time of obtaining informed consent until the end of follow-up.
 
Arm/Group Title FE 202158 1.25 FE 202158 2.5 FE 202158 3.75 PLCBO
Hide Arm/Group Description

Patients in the arm received a continuous intravenous infusion of FE 202158 1.25 ng/kg/min up to seven consecutive days.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received a continuous intravenous infusion of FE 202158 2.5 ng/kg/min up to seven consecutive days.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received a continuous intravenous infusion of FE 202158 3.75 ng/kg/min up to seven consecutive days.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Patients in the arm received a continuous intravenous infusion of isotonic saline up to seven consecutive days.
All-Cause Mortality
FE 202158 1.25 FE 202158 2.5 FE 202158 3.75 PLCBO
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
FE 202158 1.25 FE 202158 2.5 FE 202158 3.75 PLCBO
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/10 (20.00%)      2/19 (10.53%)      2/2 (100.00%)      6/21 (28.57%)    
Blood and lymphatic system disorders         
Disseminated intravascular coagulation  1  1/10 (10.00%)  1 0/19 (0.00%)  0 0/2 (0.00%)  0 0/21 (0.00%)  0
Cardiac disorders         
Cardio-respiratory arrest  1  0/10 (0.00%)  0 0/19 (0.00%)  0 1/2 (50.00%)  1 1/21 (4.76%)  1
Atrial fibrillation  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Myocarditis  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Myocardial ischaemia  1  0/10 (0.00%)  0 0/19 (0.00%)  0 1/2 (50.00%)  1 0/21 (0.00%)  0
Gastrointestinal disorders         
Gastrointestinal ischaemia  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Infections and infestations         
Haematoma infection  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Metabolism and nutrition disorders         
Hyperkalaemia  1  1/10 (10.00%)  1 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Metabolic acidosis  1  1/10 (10.00%)  1 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Nervous system disorders         
Cerebral haemorrhage  1  1/10 (10.00%)  1 0/19 (0.00%)  0 0/2 (0.00%)  0 0/21 (0.00%)  0
Renal and urinary disorders         
Oliguria  1  1/10 (10.00%)  1 0/19 (0.00%)  0 0/2 (0.00%)  0 0/21 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Acute respiratory distress syndrome  1  1/10 (10.00%)  1 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Respiratory distress  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 1/21 (4.76%)  1
Pneumothorax  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Hypercapnia  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Vascular disorders         
Peripheral ischaemia  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
FE 202158 1.25 FE 202158 2.5 FE 202158 3.75 PLCBO
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/10 (60.00%)      14/19 (73.68%)      0/2 (0.00%)      13/21 (61.90%)    
Blood and lymphatic system disorders         
Anaemia  1  0/10 (0.00%)  0 3/19 (15.79%)  3 0/2 (0.00%)  0 7/21 (33.33%)  7
Coagulopathy  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 3/21 (14.29%)  3
Disseminated intravascular coagulation  1  1/10 (10.00%)  2 0/19 (0.00%)  0 0/2 (0.00%)  0 0/21 (0.00%)  0
Thrombocytopenia  1  1/10 (10.00%)  1 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Cardiac disorders         
Atrial fibrillation  1  0/10 (0.00%)  0 3/19 (15.79%)  4 0/2 (0.00%)  0 2/21 (9.52%)  2
Bradycardia  1  1/10 (10.00%)  1 2/19 (10.53%)  3 0/2 (0.00%)  0 3/21 (14.29%)  3
Cardiac failure  1  1/10 (10.00%)  1 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Cardiac valve vegetation  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Cyanosis  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Sinus tachycardia  1  1/10 (10.00%)  1 0/19 (0.00%)  0 0/2 (0.00%)  0 0/21 (0.00%)  0
Supraventricular extrasystoles  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Tachycardia  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Gastrointestinal disorders         
Diarrhoea  1  0/10 (0.00%)  0 2/19 (10.53%)  2 0/2 (0.00%)  0 2/21 (9.52%)  2
Abdominal pain  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 1/21 (4.76%)  1
Ascites  1  1/10 (10.00%)  1 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Impaired gastric emptying  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 1/21 (4.76%)  1
Nausea  1  0/10 (0.00%)  0 2/19 (10.53%)  2 0/2 (0.00%)  0 0/21 (0.00%)  0
Vomiting  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 2/21 (9.52%)  2
Abdominal pain lower  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Constipation  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Gastric haemorrhage  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Haematemesis  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Rectal haemorrhage  1  1/10 (10.00%)  1 0/19 (0.00%)  0 0/2 (0.00%)  0 0/21 (0.00%)  0
General disorders         
Generalised oedema  1  1/10 (10.00%)  1 0/19 (0.00%)  0 0/2 (0.00%)  0 2/21 (9.52%)  2
Chest pain  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Hypothermia  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Hepatobiliary disorders         
Hepatic failure  1  2/10 (20.00%)  2 0/19 (0.00%)  0 0/2 (0.00%)  0 0/21 (0.00%)  0
Cholelithiasis  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Immune system disorders         
Hypersensitivity  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Infections and infestations         
Abdominal abscess  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Catheter related infection  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Enterobacter infection  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Genital herpes  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Pneumonia herpes viral  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Stenotrophomonas infection  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Urinary tract infection enterococcal  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Wound infection  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Injury, poisoning and procedural complications         
Post procedural complication  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 2/21 (9.52%)  2
Gastrointestinal stoma complication  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Mechanical ventilation complication  1  1/10 (10.00%)  1 0/19 (0.00%)  0 0/2 (0.00%)  0 0/21 (0.00%)  0
Investigations         
Hepatic enzyme increased  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 4/21 (19.05%)  4
Platelet count decreased  1  1/10 (10.00%)  1 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Troponin increased  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 1/21 (4.76%)  1
Blood phosphorus  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Blood phosphorus decreased  1  1/10 (10.00%)  1 0/19 (0.00%)  0 0/2 (0.00%)  0 0/21 (0.00%)  0
Blood phosphorus increased  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Blood potassium increased  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Candida serology positive  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Haemoglobin decreased  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Oxygen saturation decreased  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Metabolism and nutrition disorders         
Hypokalaemia  1  1/10 (10.00%)  1 2/19 (10.53%)  2 0/2 (0.00%)  0 2/21 (9.52%)  2
Metabolic acidosis  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Fluid retention  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 2/21 (9.52%)  2
Hypoglycaemia  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 2/21 (9.52%)  2
Dehydration  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Diabetes mellitus  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Hyperglycaemia  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Hyperlactacidaemia  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Hypoalbuminaemia  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Hypophosphataemia  1  1/10 (10.00%)  1 0/19 (0.00%)  0 0/2 (0.00%)  0 0/21 (0.00%)  0
Hypovolaemia  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Metabolic alkalosis  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Vitamin K deficiency  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Nervous system disorders         
Dysarthria  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Lethargy  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Tremor  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Psychiatric disorders         
Anxiety  1  1/10 (10.00%)  1 1/19 (5.26%)  1 0/2 (0.00%)  0 2/21 (9.52%)  2
Agitation  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 2/21 (9.52%)  2
Delirium  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 1/21 (4.76%)  1
Hallucinations  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Restlessness  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Renal and urinary disorders         
Oliguria  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Renal failure  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Renal failure acute  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Urinary bladder haemorrhage  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Reproductive system and breast disorders         
Scrotal oedema  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Respiratory, thoracic and mediastinal disorders         
Pleural effusion  1  1/10 (10.00%)  1 0/19 (0.00%)  0 0/2 (0.00%)  0 4/21 (19.05%)  4
Respiratory distress  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Epistaxis  1  1/10 (10.00%)  1 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Atelectasis  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Pulmonary oedema  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Respiratory depression  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Respiratory failure  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Skin and subcutaneous tissue disorders         
Decubitus ulcer  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Erythema  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Hyperkeratosis  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Rash macular  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Scar pain  1  0/10 (0.00%)  0 1/19 (5.26%)  1 0/2 (0.00%)  0 0/21 (0.00%)  0
Surgical and medical procedures         
Abdominal cavity drainage  1  0/10 (0.00%)  0 0/19 (0.00%)  0 0/2 (0.00%)  0 1/21 (4.76%)  1
Vascular disorders         
Hypertension  1  1/10 (10.00%)  1 4/19 (21.05%)  5 0/2 (0.00%)  0 1/21 (4.76%)  1
Hypotension  1  1/10 (10.00%)  1 1/19 (5.26%)  2 0/2 (0.00%)  0 2/21 (9.52%)  2
Vena cava thrombosis  1  1/10 (10.00%)  1 0/19 (0.00%)  0 0/2 (0.00%)  0 0/21 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
Results Point of Contact
Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01000649     History of Changes
Other Study ID Numbers: FE 202158 CS02
EudraCT: 2009-010798-19
First Submitted: September 30, 2009
First Posted: October 23, 2009
Results First Submitted: December 13, 2016
Results First Posted: June 2, 2017
Last Update Posted: September 25, 2017