Efficacy Study of Recombinant Protein (Ecallantide) to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve Repair/Replacement

ID: NCT00448864
Status: Terminated
Phase: Phase 2
Start Date: May 01, 2007
First Submitted: March 16, 2007
Last Updated: January 05, 2016
Results: Available
Success Rate: 85%
Sponsors & Collaborators: Cubist Pharmaceuticals LLC
Location: United States
Conditions: Blood Loss, Surgical
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Study Description

Brief Summary

The primary objective of this study was to assess the efficacy and safety of 2 dose levels of ecallantide versus placebo in reducing blood loss following cardiopulmonary bypass (CPB), as measured by chest tube drainage during the first 12 hours postoperatively or until the chest tube was removed, whichever came first, in patients undergoing primary coronary artery bypass grafting (CABG), single valve repair, or single valve replacement.

The secondary objective was to compare the efficacy of all ecallantide-treated participants (pooled high and low-doses) to placebo and to compare the high-dose to the low-dose ecallantide group. Other secondary objectives were to evaluate pharmacokinetics and antibody formation.

Detailed Description

This was a Phase 2, randomized, double-blind, placebo-controlled, multi-center study designed to assess the efficacy and safety of 2 dose levels of ecallantide compared to placebo in reducing chest tube drainage in participants requiring CPB for primary CABG, single valve repair, or single valve replacement. Participants were randomized in a 3:3:2 ratio to ecallantide high-dose regimen (maximum 91 mg), ecallantide low-dose regimen (maximum 15 mg), or placebo. Randomization was stratified by surgical procedure so that participants undergoing valve replacement would be evenly distributed across treatment arms. Each participant received active drug or placebo administered in stages on the day of the surgical procedure after induction of anesthesia (Day 1).

Participants were screened up to 14 days prior to surgery. Additional study procedures were conducted on Day -1 or 1, peri-operatively, during the immediate postoperative period, and on Days 2, 4, and 7 (or at the time of discharge from the hospital), and between Days 28 and 43 (follow-up).
Condition or disease Intervention/treatment Phase

Blood Loss, Surgical

Drug: Ecallantide
Other Names
DX-88
Drug: Placebo
Other Names
Phase 2

Tracking Information

First Submitted DateMarch 16, 2007
Last Update Posted DateJanuary 05, 2016
Start DateMay 01, 2007
Actual Completion DateAugust 01, 2008
Primary Completion DateJuly 01, 2008
Results First Submitted DateApril 22, 2015
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Cumulative Chest Tube Drainage During the First 12 Hours Postoperatively [Time Frame: Up to 12 hours post admission to intensive care unit (ICU)]

    Mean volume of chest tube drainage during the first 12 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group.

Original Primary Outcome Measures

  • Cumulative Chest Tube Drainage During the First 12 Hours Postoperatively

    Mean volume of chest tube drainage during the first 12 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group.

Current Secondary Outcome Measures

  • Cumulative Chest Tube Drainage at 24 Hours Postoperatively [Time Frame: Up to 24 hours post admission to ICU]

    Mean volume of chest tube drainage during the first 24 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group.

  • Number of Participants With Treatment-emergent Adverse Events [Time Frame: up to 28 days post admission to ICU]

    A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  • Pharmacokinetics: Area Under the Concentration Time Curve [Time Frame: 1, 2, 4, and 8 hours after end of study drug infusion]

    Results are reported in terms of the Area Under Plasma Concentration Time Curve (AUC), measured as milligram hour per liter (mg*h/L)

Original Secondary Outcome Measures

  • Pharmacokinetics: Area Under the Concentration Time Curve

    Results are reported in terms of the Area Under Plasma Concentration Time Curve (AUC), measured as milligram hour per liter (mg*h/L)

  • Number of Participants With Treatment-emergent Adverse Events

    A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  • Cumulative Chest Tube Drainage at 24 Hours Postoperatively

    Mean volume of chest tube drainage during the first 24 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group.

Study Design

Brief TitleEfficacy Study of Recombinant Protein (Ecallantide) to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve Repair/Replacement
Official TitleKALAHARI-1: Kallikrein Antagonist (DX-88 [Ecallantide]) Effect on Blood Loss Associated With Heart Surgery Requiring Institution of Bypass
Brief Summary

The primary objective of this study was to assess the efficacy and safety of 2 dose levels of ecallantide versus placebo in reducing blood loss following cardiopulmonary bypass (CPB), as measured by chest tube drainage during the first 12 hours postoperatively or until the chest tube was removed, whichever came first, in patients undergoing primary coronary artery bypass grafting (CABG), single valve repair, or single valve replacement.

The secondary objective was to compare the efficacy of all ecallantide-treated participants (pooled high and low-doses) to placebo and to compare the high-dose to the low-dose ecallantide group. Other secondary objectives were to evaluate pharmacokinetics and antibody formation.

Detailed Description

This was a Phase 2, randomized, double-blind, placebo-controlled, multi-center study designed to assess the efficacy and safety of 2 dose levels of ecallantide compared to placebo in reducing chest tube drainage in participants requiring CPB for primary CABG, single valve repair, or single valve replacement. Participants were randomized in a 3:3:2 ratio to ecallantide high-dose regimen (maximum 91 mg), ecallantide low-dose regimen (maximum 15 mg), or placebo. Randomization was stratified by surgical procedure so that participants undergoing valve replacement would be evenly distributed across treatment arms. Each participant received active drug or placebo administered in stages on the day of the surgical procedure after induction of anesthesia (Day 1).

Participants were screened up to 14 days prior to surgery. Additional study procedures were conducted on Day -1 or 1, peri-operatively, during the immediate postoperative period, and on Days 2, 4, and 7 (or at the time of discharge from the hospital), and between Days 28 and 43 (follow-up).

Study TypeInterventional
Study PhasePhase 2
Estimated Enrollment
75
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
Primary Purpose
Prevention
Conditions
Blood Loss, Surgical
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Ecallantide

Other Names
DX-88
Drug: Placebo

Other Names
Study Groups/Cohorts
Ecallantide - Low Dose Regimen
Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 milliliters per hour (mL/hr) for 4 hours.

Ecallantide - High Dose Regimen
Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 milliliters per hour (mL/hr) for 4 hours.

Placebo
Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.

Study Arms
Experimental Ecallantide - High Dose Regimen
Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 milliliters per hour (mL/hr) for 4 hours.
Drug : Ecallantide

Experimental Ecallantide - Low Dose Regimen
Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 milliliters per hour (mL/hr) for 4 hours.
Drug : Ecallantide

Placebo Comparator Placebo
Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
Drug : Placebo

Arm Intervention/Treatment
Experimental Ecallantide - High Dose Regimen
Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 milliliters per hour (mL/hr) for 4 hours.
Drug : Ecallantide
Experimental Ecallantide - Low Dose Regimen
Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 milliliters per hour (mL/hr) for 4 hours.
Drug : Ecallantide
Placebo Comparator Placebo
Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
Drug : Placebo

Recruitment Information

Recruitment Status:Terminated
Enrollment75
Completion DateAugust 01, 2008
Eligibility Criteria: Inclusion Criteria:
- Men and women ≥18 to ≤85 years of age
- Elective primary coronary artery bypass grafting (CABG), single valve repair, or single valve replacement requiring CPB and full sternotomy
- No plan to use desmopressin acetate (DDAVP), atrial natriuretic hormone, E-aminocaproic acid (EACA), tranexamic acid, or aprotinin during or postoperatively
- Female participants must be non-lactating and not pregnant
- If of childbearing potential, female participants must agree to use adequate contraception for 1 month after receiving study drug

Exclusion Criteria:
- Concomitant surgery including but not limited to atrial septal defect repair, multiple valve replacement, carotid endarterectomy, and combined CABG and valve procedure
- Planned hypothermic CPB using temperatures less than 28 degrees Celsius
- Weight <55 kilograms (kg)
- Major end organ dysfunction, defined as:
- Cardiac:
- Left ventricular ejection fraction (LVEF) < 30% by left ventriculography, echocardiogram, or catheterization (within 90 days prior to screening)
- Use of positive IV inotropic agents within 12 hours prior to surgery
- Preoperative use of intra-aortic balloon pump (IABP), left ventricular assist device (LVAD), or extracorporeal membrane oxygenation (ECMO)
- Renal: Serum creatinine > 1.5 milligrams per deciliter (mg/dL)
- Hepatic: Aspartate aminotransferase (AST) or alanine transferase (ALT) > 2.5 x upper limit normal
- Hematologic:
- Preoperative hematocrit (Hct) < 30%
- Platelet count < 100,000/mm^3
- Planned transfusion during surgical procedure
- History or family history of bleeding or clotting disorder (for example, von Willebrand's Disease, idiopathic thrombocytopenia purpura (ITP), thrombotic thrombocytopenia purpura (TTP), hematologic malignancy)
- Prothrombin time (PT) or activated partial thromboplastin time
- (aPTT) > 1.5 x normal range; if receiving unfractionated heparin preoperatively, then abnormal preoperative PT/aPTT permitted
- Serious intercurrent illness or active infection
- Previous exposure to ecallantide
- Known allergy to ecallantide or any of its components, fentanyl, midazolam, isoflurane, propofol, morphine, heparin, or protamine
- Autologous blood donation ≤ 30 days month prior to surgery
- Known substance abuse within 6 months prior to surgery
- Receipt of an investigational drug or device within 30 days prior to participation in the current study
- Administration of:
- Eptifibatide < 12 hours prior to surgery
- Tirofiban hydrochloride (HCl) < 12 hours prior to surgery
- Enoxaparin sodium or other low- molecular-weight heparin < 24 hours prior to surgery
- Clopidogrel <5 days prior to surgery
- Warfarin <5 days prior to surgery (Warfarin must be discontinued 5 days prior to surgery and PT must be < 18 seconds)
- Ticlopidine <7 days prior to surgery
- Abciximab <24 hours prior to surgery
GenderAll
Age18 Years to 85 Years
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT00448864
Other Study ID Numbers
1501-001
DX-88/16
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Cubist Pharmaceuticals LLC
Collaborators
Not Available
Investigators
Study Director
Andrew L Sternlicht, MD
Dyax Corp.

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Not Available

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not Available

Reporting Groups

TitleDescription
Ecallantide - Low Dose Regimen
Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 milliliters per hour (mL/hr) for 4 hours.
Ecallantide - High Dose Regimen
Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
Placebo
Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.

Participant Flow: Overall

Ecallantide - Low Dose RegimenEcallantide - High Dose RegimenPlacebo
262518
Started272919
Completed222418
Not Completed551
Death100
Lost to Follow-up310
Physician Decision101
Protocol Violation020
Withdrawal by Subject020

Baseline Characteristics

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized participants who received at least 1 dose of study drug.

Reporting Groups

TitleDescription
Ecallantide - Low Dose Regimen
Participants received a maximum of 15 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
Ecallantide - High Dose Regimen
Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
Placebo
Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
Total
Total of all reporting groups

Baseline Measures

Ecallantide - Low Dose RegimenEcallantide - High Dose RegimenPlaceboTotal
Overall Participants Analyzed
Units: Participants
Participants Analyzed
26251869
26251869
Age
Units: participants - Number
Participants Analyzed
26251869
<=18 years0000
>=65 years99725
Between 18 and 65 years17161144
Gender
Units: participants - Number
Participants Analyzed
26251869
Female47314
Male22181555

Outcome Measures

1. Primary: Cumulative Chest Tube Drainage During the First 12 Hours Postoperatively

Measure Type
Primary
Measure Title
Cumulative Chest Tube Drainage During the First 12 Hours Postoperatively
Measure Description
Mean volume of chest tube drainage during the first 12 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group.
Time Frame
Up to 12 hours post admission to intensive care unit (ICU)

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 dose of study drug.

Reporting Groups

TitleDescription
Ecallantide - Low Dose Regimen
Participants received a maximum of 15 mg ecallantide in stages. Intravenous (IV) infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
Ecallantide - High Dose Regimen
Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
Placebo
Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.

Outcome Measures

Ecallantide - Low Dose RegimenEcallantide - High Dose RegimenPlacebo
Participants Analyzed
Units: Participants
262518
Cumulative Chest Tube Drainage During the First 12 Hours Postoperatively
Units: Milliliters - Mean (Standard Deviation)
729.9 (432.03)935.8 (510.18)1400.7 (1371.65)

2. Secondary: Cumulative Chest Tube Drainage at 24 Hours Postoperatively

Measure Type
Secondary
Measure Title
Cumulative Chest Tube Drainage at 24 Hours Postoperatively
Measure Description
Mean volume of chest tube drainage during the first 24 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group.
Time Frame
Up to 24 hours post admission to ICU

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 dose of study drug.

Reporting Groups

TitleDescription
Ecallantide - Low Dose Regimen
Participants received a maximum of 15 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
Ecallantide - High Dose Regimen
Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
Placebo
Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.

Outcome Measures

Ecallantide - Low Dose RegimenEcallantide - High Dose RegimenPlacebo
Participants Analyzed
Units: Participants
262518
Cumulative Chest Tube Drainage at 24 Hours Postoperatively
Units: Milliliters - Mean (Standard Deviation)
82.9 (74.99)149.8 (132.27)225.3 (453.60)

3. Secondary: Number of Participants With Treatment-emergent Adverse Events

Measure Type
Secondary
Measure Title
Number of Participants With Treatment-emergent Adverse Events
Measure Description
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time Frame
up to 28 days post admission to ICU

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 dose of study drug.

Reporting Groups

TitleDescription
Ecallantide - Low Dose Regimen
Participants received a maximum of 15 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
Ecallantide - High Dose Regimen
Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
Placebo
Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.

Outcome Measures

Ecallantide - Low Dose RegimenEcallantide - High Dose RegimenPlacebo
Participants Analyzed
Units: Participants
262518
Number of Participants With Treatment-emergent Adverse Events
Units: participants - Number
252318

4. Secondary: Pharmacokinetics: Area Under the Concentration Time Curve

Measure Type
Secondary
Measure Title
Pharmacokinetics: Area Under the Concentration Time Curve
Measure Description
Results are reported in terms of the Area Under Plasma Concentration Time Curve (AUC), measured as milligram hour per liter (mg*h/L)
Time Frame
1, 2, 4, and 8 hours after end of study drug infusion

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 dose of study drug.

Reporting Groups

TitleDescription
Ecallantide - Low Dose Regimen
Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
Ecallantide - High Dose Regimen
Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.

Outcome Measures

Ecallantide - Low Dose RegimenEcallantide - High Dose Regimen
Participants Analyzed
Units: Participants
2625
Pharmacokinetics: Area Under the Concentration Time Curve
Units: mg*h/L - Mean (Standard Deviation)
1.39 (0.589)13.6 (3.58)

Serious Adverse Events

Time Frame
Not Available
Additional Description
Not Available
Frequency Threshold0% (Threshold above which other adverse events are reported)

Reporting Groups

TitleDescription
Ecallantide - Low Dose Regimen
Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
Ecallantide - High Dose Regimen
Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
Placebo
Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.

Serious Adverse Events

Ecallantide - Low Dose RegimenEcallantide - High Dose RegimenPlacebo
Total, serious adverse events
No. of participants affected / at risk9/26 (0.00%)4/25 (0.00%)7/18 (0.00%)
Coagulopathy
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Arrhythmia supraventricular
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Cardiac failure congestive
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Myocardial infarction
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Ventricular tachycardia
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Ileus
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Multi-organ failure
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Infection
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Wound infection
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Post procedural haemorrhage
No. of participants affected / at risk2/26 (0.00%)2/25 (0.00%)0/18 (0.00%)
Transfusion reaction
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
International normalised ratio increased
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Dehydration
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Hyperkalaemia
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Cerebral infarction
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Convulsion
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Syncope
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Pneumothorax
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Haemodynamic instability
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Haemorrhage
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)3/18 (0.00%)
Venous thrombosis
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Hypotension
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)

Other Adverse Events

Time Frame
Not Available
Additional Description
Not Available
Frequency Threshold0% (Threshold above which other adverse events are reported)

Reporting Groups

TitleDescription
Ecallantide - Low Dose Regimen
Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
Ecallantide - High Dose Regimen
Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
Placebo
Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.

Other Adverse Events

Ecallantide - Low Dose RegimenEcallantide - High Dose RegimenPlacebo
Total, other adverse events
No. of participants affected / at risk25/26 (0.00%)23/25 (0.00%)18/18 (100.00%)
Anaemia
No. of participants affected / at risk5/26 (0.00%)6/25 (0.00%)6/18 (0.00%)
Coagulopathy
No. of participants affected / at risk1/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Disseminated intravascular coagulation
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Haemorrhagic anaemia
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Leukocytosis
No. of participants affected / at risk2/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Thrombocytopenia
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)3/18 (0.00%)
Angina pectoris
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Arrhythmia
No. of participants affected / at risk0/26 (0.00%)2/25 (0.00%)0/18 (0.00%)
Atrial fibrillation
No. of participants affected / at risk6/26 (0.00%)5/25 (0.00%)7/18 (0.00%)
Atrial flutter
No. of participants affected / at risk0/26 (0.00%)2/25 (0.00%)1/18 (0.00%)
Atrioventricular block
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Atrioventricular block first degree
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Bradycardia
No. of participants affected / at risk0/26 (0.00%)2/25 (0.00%)2/18 (0.00%)
Bundle branch block
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Myocardial infarction
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Pericardial effusion
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Pericarditis
No. of participants affected / at risk0/26 (0.00%)2/25 (0.00%)1/18 (0.00%)
Sinus tachycardia
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Supraventricular extrasystoles
No. of participants affected / at risk0/26 (0.00%)2/25 (0.00%)0/18 (0.00%)
Supraventricular tachycardia
No. of participants affected / at risk2/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Tachycardia
No. of participants affected / at risk1/26 (0.00%)5/25 (0.00%)0/18 (0.00%)
Ventricular extrasystoles
No. of participants affected / at risk1/26 (0.00%)2/25 (0.00%)0/18 (0.00%)
Ventricular tachycardia
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)1/18 (0.00%)
Hearing impaired
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Retinal vascular thrombosis
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Vision blurred
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Abdominal pain
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Constipation
No. of participants affected / at risk3/26 (0.00%)6/25 (0.00%)5/18 (0.00%)
Diarrhoea
No. of participants affected / at risk0/26 (0.00%)2/25 (0.00%)1/18 (0.00%)
Dyspepsia
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Haematochezia
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Nausea
No. of participants affected / at risk1/26 (0.00%)5/25 (0.00%)3/18 (0.00%)
Oral pain
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Pancreatitis
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Vomiting
No. of participants affected / at risk1/26 (0.00%)3/25 (0.00%)0/18 (0.00%)
Chest pain
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Chills
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Crepitations
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Fatigue
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Generalised oedema
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Infusion site reaction
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Localised oedema
No. of participants affected / at risk2/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Oedema
No. of participants affected / at risk2/26 (0.00%)2/25 (0.00%)0/18 (0.00%)
Oedema peripheral
No. of participants affected / at risk2/26 (0.00%)2/25 (0.00%)1/18 (0.00%)
Pain
No. of participants affected / at risk2/26 (0.00%)1/25 (0.00%)2/18 (0.00%)
Pyrexia
No. of participants affected / at risk5/26 (0.00%)2/25 (0.00%)2/18 (0.00%)
Bacterial infection
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Candidiasis
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Cellulitis
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Lobar pneumonia
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Sepsis
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Sinusitis
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Skin infection
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Upper respiratory tract infection
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Urinary tract infection
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)3/18 (0.00%)
Anaemia postoperative
No. of participants affected / at risk0/26 (0.00%)2/25 (0.00%)1/18 (0.00%)
Arterial injury
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Contusion
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Incision site pain
No. of participants affected / at risk4/26 (0.00%)3/25 (0.00%)3/18 (0.00%)
Post procedural discomfort
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Post procedural haemorrhage
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Post procedural myocardial infarction
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Post procedural oedema
No. of participants affected / at risk2/26 (0.00%)4/25 (0.00%)3/18 (0.00%)
Postoperative respiratory distress
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Postoperative thoracic procedure complication
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Postoperative wound complication
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Procedural hypotension
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Procedural pain
No. of participants affected / at risk3/26 (0.00%)9/25 (0.00%)5/18 (0.00%)
Transfusion reaction
No. of participants affected / at risk1/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Wound dehiscence
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Blood albumin decreased
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Blood bilirubin increased
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)1/18 (0.00%)
Blood chloride increased
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Blood creatine phosphokinase increased
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)1/18 (0.00%)
Blood creatinine increased
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Blood fibrinogen increased
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Blood glucose increased
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Blood lactate dehydrogenase increased
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)1/18 (0.00%)
Blood phosphorus decreased
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Body temperature increased
No. of participants affected / at risk3/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Breath sounds abnormal
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Cardiac enzymes increased
No. of participants affected / at risk3/26 (0.00%)1/25 (0.00%)1/18 (0.00%)
Cardiac murmur
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Electrocardiogram
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Electrocardiogram ST segment elevation
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Gamma-glutamyltransferase increased
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Haematocrit decreased
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Haemoglobin
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Haemoglobin decreased
No. of participants affected / at risk0/26 (0.00%)3/25 (0.00%)0/18 (0.00%)
Heart rate decreased
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Heart rate increased
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Mean arterial pressure decreased
No. of participants affected / at risk0/26 (0.00%)2/25 (0.00%)0/18 (0.00%)
Oxygen saturation normal
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Platelet count decreased
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Platelet count increased
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Protein total decreased
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Prothrombin time prolonged
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Thoracic cavity drainage test abnormal
No. of participants affected / at risk3/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Urine analysis abnormal
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Urine output decreased
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)3/18 (0.00%)
White blood cell count increased
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Electrolyte depletion
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Electrolyte imbalance
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Fluid overload
No. of participants affected / at risk2/26 (0.00%)1/25 (0.00%)2/18 (0.00%)
Glucose tolerance impaired
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Hyperglycaemia
No. of participants affected / at risk1/26 (0.00%)3/25 (0.00%)1/18 (0.00%)
Hyperkalaemia
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)1/18 (0.00%)
Hypocalcaemia
No. of participants affected / at risk0/26 (0.00%)2/25 (0.00%)0/18 (0.00%)
Hypoglycaemia
No. of participants affected / at risk2/26 (0.00%)2/25 (0.00%)1/18 (0.00%)
Hypokalaemia
No. of participants affected / at risk2/26 (0.00%)3/25 (0.00%)1/18 (0.00%)
Hypomagnesaemia
No. of participants affected / at risk2/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Hyponatraemia
No. of participants affected / at risk0/26 (0.00%)2/25 (0.00%)0/18 (0.00%)
Hypophosphataemia
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Hypovolaemia
No. of participants affected / at risk3/26 (0.00%)1/25 (0.00%)2/18 (0.00%)
Malnutrition
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Metabolic acidosis
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Back pain
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Muscular weakness
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Pain in extremity
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Dizziness
No. of participants affected / at risk3/26 (0.00%)2/25 (0.00%)0/18 (0.00%)
Hypoaesthesia
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Presyncope
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Restless legs syndrome
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Sensory loss
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Somnolence
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Syncope
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Tremor
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Agitation
No. of participants affected / at risk1/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Alcohol withdrawal syndrome
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Anxiety
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)1/18 (0.00%)
Confusional state
No. of participants affected / at risk0/26 (0.00%)2/25 (0.00%)0/18 (0.00%)
Delirium
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Delusion
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Hallucination
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Hallucination, visual
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Insomnia
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)2/18 (0.00%)
Mental status changes
No. of participants affected / at risk0/26 (0.00%)2/25 (0.00%)0/18 (0.00%)
Paranoia
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Staring
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Dysuria
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Oliguria
No. of participants affected / at risk1/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Renal failure
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Renal failure acute
No. of participants affected / at risk2/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Renal impairment
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Urinary retention
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Acute pulmonary oedema
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Atelectasis
No. of participants affected / at risk3/26 (0.00%)3/25 (0.00%)3/18 (0.00%)
Bronchospasm
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Cough
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Dysphonia
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Dyspnoea
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)1/18 (0.00%)
Epistaxis
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Hiccups
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Hydropneumothorax
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Hypercapnia
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Hypoventilation
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Hypoxia
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Pharyngolaryngeal pain
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Pleural effusion
No. of participants affected / at risk6/26 (0.00%)3/25 (0.00%)6/18 (0.00%)
Pneumonitis
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Pneumothorax
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)2/18 (0.00%)
Pulmonary congestion
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Pulmonary oedema
No. of participants affected / at risk1/26 (0.00%)2/25 (0.00%)1/18 (0.00%)
Respiratory failure
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Wheezing
No. of participants affected / at risk2/26 (0.00%)1/25 (0.00%)2/18 (0.00%)
Dermatitis contact
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Erythema
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Pruritus
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Rash generalised
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)
Incisional drainage
No. of participants affected / at risk1/26 (0.00%)0/25 (0.00%)0/18 (0.00%)
Oxygen supplementation
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)1/18 (0.00%)
Haemorrhage
No. of participants affected / at risk1/26 (0.00%)2/25 (0.00%)2/18 (0.00%)
Hypertension
No. of participants affected / at risk4/26 (0.00%)4/25 (0.00%)1/18 (0.00%)
Hypotension
No. of participants affected / at risk7/26 (0.00%)7/25 (0.00%)5/18 (0.00%)
Orthostatic hypotension
No. of participants affected / at risk0/26 (0.00%)0/25 (0.00%)1/18 (0.00%)
Phlebitis
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)1/18 (0.00%)
Thrombophlebitis
No. of participants affected / at risk0/26 (0.00%)1/25 (0.00%)0/18 (0.00%)

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Results Point of Contact

Name/TitleOrganizationPhoneEmail
Vice President, Clinical Research
Cubist Pharmaceuticals
(781) 860-8660