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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001254-26 | EudraCT Number |
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The purpose of this trial is to investigate the potential of FE 202158 as a treatment which can stabilize blood pressure for treatment of patients in early septic shock.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug | Experimental | FE 202158 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FE 202158 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Maintaining Target/Adequate Mean Arterial Pressure (MAP>60 mmHg) Without Norepinephrine | Mean arterial pressure (MAP) was measured intra-arterially on a continuous basis. Success percentage of patients maintaining target/adequate MAP (>60 mmHg) without norepinephrine is presented. | Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points. |
| Cumulative Dose of FE 202158 | Cumulative dose of FE 202158 was calculated from Day 1 up to Day 7. | Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points. |
| Infusion Rate of FE 202158 | Infusion rate of FE 202158 was presented from Day 1 up to Day 7. | Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points. |
| Cumulative Dose of Norepinephrine | Norepinephrine was infused as required to maintain the target mean arterial pressure, if the highest infusion rate allowed of experimental drug FE 202158 did not provide adequate vasopressor support. Cumulative dose of norepinephrine was calculated from Day 1 up to Day 7. | Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points. |
| Infusion Rate of Norepinephrine |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Output | The urinary output was recorded every 24 hours up to Day 7, or as long as the patient was in intensive care unit. | Day 1 up to Day 7 post-infusion (Data collected on Day 1 at 24 h, Day 2 at 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasme Hospital Free University of Brussels | Brussels | Belgium | ||||
| Saint-Luc University Hospital |
Of the 159 patients screened, 31 patients were randomised and 30 patients were dosed. One patient in the 3.75 ng/kg/min dose group did not receive any study treatment due to an adverse event (elevation of troponin) recorded prior to infusion.
The patients were recruited at the respective intensive care units at four centers (3 in Belgium and 1 in Denmark) between 05 Jul 2012 to 15 Nov 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Infusion Regimen 1: 3.75 ng/kg/Min | FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days. |
| FG001 | Infusion Regimen 2: 5.0 ng/kg/Min | FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days. |
| FG002 | Infusion Regimen 3: 7.5 ng/kg/Min | FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days. |
| FG003 | Infusion Regimen 4: Modified 3.75 ng/kg/Min | FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Infusion Regimen 1 | FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days. |
| BG001 | Infusion Regimen 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Patients Maintaining Target/Adequate Mean Arterial Pressure (MAP>60 mmHg) Without Norepinephrine | Mean arterial pressure (MAP) was measured intra-arterially on a continuous basis. Success percentage of patients maintaining target/adequate MAP (>60 mmHg) without norepinephrine is presented. | Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed. | Posted | Number | 60% Confidence Interval | Percentage of patients | Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points. |
|
Adverse events were recorded from start of study up to the end of trial on Day 28, or end of follow-up period as applicable.
Collection of adverse events comprised the patient's positive response to questions about their health, symptoms spontaneously reported by the patient, and clinically relevant changes and abnormalities observed by the investigator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Infusion Regimen 1: 3.75 ng/kg/Min | FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
There were no limitations or caveats in this trial
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
Not provided
| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| C559490 | vasopressin, Phe(2)-Ile(3)-Hgn(4)-Orn(iPr)(8)- |
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Norepinephrine was infused as required to maintain the target mean arterial pressure, if the highest infusion rate allowed of experimental drug FE 202158 did not provide adequate vasopressor support. Infusion rates and all changes in infusion rates of norepinephrine were recorded continuously during the 7 day maximum treatment period. |
| Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points. |
| Time to Septic Shock Resolution | The Kaplan-Meyer estimation of time to out of septic shock was estimated where time to (first) septic shock resolution was defined as time of end of infusion regimen. Intermittent off treatment periods were regarded as part of the shock duration. Time to all but one patient out of septic shock is presented. | Day 1 up to Day 28 |
| Fluid Balance |
The fluid balance (accumulated input/output) was recorded in 24-hour collecting periods when the patient was in the intensive care unit and during the infusion of FE 202158. |
| Day 1 up to Day 7 post-infusion (Data collected on Day 1 at 24 h, Day 2 at 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points. |
| Summary of Investigator Reported Outcomes | Investigator reported outcome on FE 202158 performance. Answers were graded on a visual analogue scale (VAS) from 0 to 10, 0 being the worst and 10 being the best outcome. | Day 1 up to Day 2 |
| Morbidity Assessment | Percentage of all the "Days alive and out/free of" intensive care unit, hospital, dialysis, or ventilation within Day 28 were summarized. Patients dying before or at Day 28 were counted as zero. | Day 1 up to Day 28 |
| Graded Morbidity | Collection of data on graded morbidity was performed on Day 28 in addition to the collection of data on time of stay in intensive care unit and hospital. | Day 1 up to Day 28 |
| Mortality | Collection of data on mortality was performed on Day 28 in addition to the collection of data on time of stay in intensive care unit and hospital. | Day 1 up to Day 28 |
| Adverse Effects on Lab Parameters, Vital Signs and Electrocardiogram | Significant changes for vital signs (blood pressure, heart rate, mean arterial pressure), electrocardiogram (ECG), and laboratory parameters (clinical chemistry, haematology, haemostasis, and urinary parameters). | Day 1 up to Day 7, and at follow-up assessments performed 24-72 hours after end of IMP infusion |
| Brussels |
| Belgium |
| University Hospital Brussels | Brussels | Belgium |
| Hvidovre Hospital | Hvidovre | Denmark |
| Protocol Violation |
|
FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days. |
| BG002 | Infusion Regimen 3 | FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days. |
| BG003 | Infusion Regimen 4 | FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Total Sequential Organ Failure Assessment Score | The Sequential Organ Failure Assessment score (SOFA) score is a scoring system to determine the extent of a person's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. The total SOFA score is a sum of the individual scores and range from 4 to 24, 4 being the best and 24 being the worst patient status. | Mean | Standard Deviation | Score on scale |
|
| Septic shock characteristic: Primary infection type | Number | patients |
|
| Septic shock characteristic: Primary infection location | Number | patients |
|
| OG001 | Infusion Regimen 2: 5.0 ng/kg/Min | FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days. |
| OG002 | Infusion Regimen 3: 7.5 ng/kg/Min | FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days. |
| OG003 | Infusion Regimen 4: Modified 3.75 ng/kg/Min | FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days. |
|
|
| Secondary | Urinary Output | The urinary output was recorded every 24 hours up to Day 7, or as long as the patient was in intensive care unit. | Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed. | Posted | Mean | 60% Confidence Interval | mL/kg | Day 1 up to Day 7 post-infusion (Data collected on Day 1 at 24 h, Day 2 at 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points. |
|
|
|
| Secondary | Fluid Balance | The fluid balance (accumulated input/output) was recorded in 24-hour collecting periods when the patient was in the intensive care unit and during the infusion of FE 202158. | Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed. | Posted | Mean | 60% Confidence Interval | mL/kg | Day 1 up to Day 7 post-infusion (Data collected on Day 1 at 24 h, Day 2 at 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points. |
|
|
|
| Secondary | Summary of Investigator Reported Outcomes | Investigator reported outcome on FE 202158 performance. Answers were graded on a visual analogue scale (VAS) from 0 to 10, 0 being the worst and 10 being the best outcome. | Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed. | Posted | Mean | Standard Deviation | Score on scale | Day 1 up to Day 2 |
|
|
|
| Secondary | Morbidity Assessment | Percentage of all the "Days alive and out/free of" intensive care unit, hospital, dialysis, or ventilation within Day 28 were summarized. Patients dying before or at Day 28 were counted as zero. | Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed. | Posted | Number | percentage of days within 28 days | Day 1 up to Day 28 |
|
|
|
| Secondary | Graded Morbidity | Collection of data on graded morbidity was performed on Day 28 in addition to the collection of data on time of stay in intensive care unit and hospital. | Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed. | Posted | Number | patients | Day 1 up to Day 28 |
|
|
|
| Primary | Cumulative Dose of FE 202158 | Cumulative dose of FE 202158 was calculated from Day 1 up to Day 7. | Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed. | Posted | Mean | 60% Confidence Interval | ng/kg | Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points. |
|
|
|
| Primary | Infusion Rate of FE 202158 | Infusion rate of FE 202158 was presented from Day 1 up to Day 7. | Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed. | Posted | Mean | Standard Deviation | ng/kg/min | Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points. |
|
|
|
| Primary | Cumulative Dose of Norepinephrine | Norepinephrine was infused as required to maintain the target mean arterial pressure, if the highest infusion rate allowed of experimental drug FE 202158 did not provide adequate vasopressor support. Cumulative dose of norepinephrine was calculated from Day 1 up to Day 7. | Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed. One patient in the 7.5 ng/kg/min group started the vasopressor support without prior administration of norepinephrine, and MAP was adequately controlled as needed. | Posted | Mean | 60% Confidence Interval | µg/kg | Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points. |
|
|
|
| Primary | Infusion Rate of Norepinephrine | Norepinephrine was infused as required to maintain the target mean arterial pressure, if the highest infusion rate allowed of experimental drug FE 202158 did not provide adequate vasopressor support. Infusion rates and all changes in infusion rates of norepinephrine were recorded continuously during the 7 day maximum treatment period. | Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed. One patient in the 7.5 ng/kg/min group started the vasopressor support without prior administration of norepinephrine, and MAP was adequately controlled as needed. | Posted | Mean | Standard Deviation | µg/kg/min | Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points. |
|
|
|
| Primary | Time to Septic Shock Resolution | The Kaplan-Meyer estimation of time to out of septic shock was estimated where time to (first) septic shock resolution was defined as time of end of infusion regimen. Intermittent off treatment periods were regarded as part of the shock duration. Time to all but one patient out of septic shock is presented. | Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed. | Posted | Number | Hours | Day 1 up to Day 28 |
|
|
|
| Secondary | Mortality | Collection of data on mortality was performed on Day 28 in addition to the collection of data on time of stay in intensive care unit and hospital. | Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed. | Posted | Number | patients | Day 1 up to Day 28 |
|
|
|
| Secondary | Adverse Effects on Lab Parameters, Vital Signs and Electrocardiogram | Significant changes for vital signs (blood pressure, heart rate, mean arterial pressure), electrocardiogram (ECG), and laboratory parameters (clinical chemistry, haematology, haemostasis, and urinary parameters). | The safety analysis set comprised of all allocated and dosed patients and were analyzed according to the actual dosing regimen received. | Posted | Number | patients | Day 1 up to Day 7, and at follow-up assessments performed 24-72 hours after end of IMP infusion |
|
|
|
| 1 |
| 5 |
| 4 |
| 5 |
| EG001 | Infusion Regimen 2: 5.0 ng/kg/Min | FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days. | 4 | 7 | 7 | 7 |
| EG002 | Infusion Regimen 3: 7.5 ng/kg/Min | FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days. | 2 | 5 | 4 | 5 |
| EG003 | Infusion Regimen 4: Modified 3.75 ng/kg/Min | FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days. | 3 | 13 | 12 | 13 |
| EG004 | Total | Summation of adverse events in all treatment arms | 10 | 30 | 27 | 30 |
| Cardiac failure | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Myocardial ischemia | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Intestinal ischemia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hepatic congestion | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Colostomy | Surgical and medical procedures | MedDRA 15.0 | Systematic Assessment |
|
| Distributive shock | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Peripheral ischemia | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cyanosis | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Myocardial depression | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal compartment syndrome | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Oesophageal perforation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hypothermia | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Medical device complication | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cytolytic hepatitis | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hepatic congestion | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Troponin increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Metabolic alkalosis | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hypoventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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| Peripheral coldness | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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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.
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| Day 2 (Post 48 h) |
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| Day 3 (Post 72 h) |
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| Day 4 (Post 96 h) |
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| Day 5 (Post 120 h) |
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| Day 6 (Post 144 h) |
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| Day 7 (Post 168 h) |
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| Day 2 (Post 48 h) |
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| Day 3 (Post 72 h) |
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| Day 4 (Post 96 h) |
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| Day 5 (Post 120 h) |
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| Day 6 (Post 144 h) |
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| Day 7 (Post 168 h) |
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| MAP maintained within desired boundaries (Day 1) |
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| MAP maintained within desired boundaries (Day 2) |
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| Confidence to use FE 202158 as primary treatment |
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| Days alive and out of hospital |
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| Days alive and free of dialysis |
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| Days alive and free of ventilation |
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| In hospital (not intensive care unit) |
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| In intensive care unit |
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| Dead |
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| Day 1 (Post 24 h) |
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| Day 2 (Post 36 h) |
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| Day 2 (Post 48 h) |
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| Day 3 (Post 72 h) |
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| Day 4 (Post 96 h) |
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| Day 5 (Post 120 h) |
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| Day 6 (Post 144 h) |
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| Day 7 (Post 168 h) |
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| Day 1 (Post 24 h) |
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| Day 2 (Post 36 h) |
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| Day 2 (Post 48 h) |
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| Day 3 (Post 72 h) |
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| Day 4 (Post 96 h) |
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| Day 5 (Post 120 h) |
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| Day 6 (Post 144 h) |
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| Day 7 (Post 168 h) |
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| Day 1 (Post 24 h) |
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| Day 2 (Post 36 h) |
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| Day 2 (Post 48 h) |
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| Day 3 (Post 72 h) |
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| Day 4 (Post 96 h) |
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| Day 5 (Post 120 h) |
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| Day 6 (Post 144 h) |
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| Day 7 (Post 168 h) |
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| Day 1 (Post 24 h) |
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| Day 2 (Post 36 h) |
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| Day 2 (Post 48 h) |
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| Day 3 (Post 72 h) |
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| Day 4 (Post 96 h) |
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| Day 5 (Post 120 h) |
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| Day 6 (144 h) |
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| Day 7 (Post 168 h) |
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| Title | Measurements |
|---|---|
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| Modified 3.75 ng/kg/min (n=13) |
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| Dead |
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| Patients with adverse effects on vital signs |
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| Patients with adverse effects on electrocardiogram |
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