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A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00475852
Recruitment Status : Completed
First Posted : May 21, 2007
Results First Posted : May 10, 2012
Last Update Posted : March 8, 2013
Sponsor:
Information provided by (Responsible Party):
Scios, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Heart Decompensation
Interventions Drug: Nesiritide
Drug: Placebo
Enrollment 7141
Recruitment Details  
Pre-assignment Details Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure (ASCEND-HF)
Arm/Group Title Nesiritide Placebo
Hide Arm/Group Description 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Period Title: Overall Study
Started 3564 3577
Completed 3047 3029
Not Completed 517 548
Reason Not Completed
Death             444             456
Withdrawal by Subject             19             24
Lost to Follow-up             54             68
Arm/Group Title Nesiritide Placebo Total
Hide Arm/Group Description 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs Total of all reporting groups
Overall Number of Baseline Participants 3564 3577 7141
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3564 participants 3577 participants 7141 participants
<=18 years
4
   0.1%
2
   0.1%
6
   0.1%
Between 18 and 65 years
1572
  44.1%
1597
  44.6%
3169
  44.4%
>=65 years
1988
  55.8%
1978
  55.3%
3966
  55.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3564 participants 3577 participants 7141 participants
65.5  (14.09) 65.4  (14.20) 65.5  (14.14)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3564 participants 3577 participants 7141 participants
<=64 1576 1599 3175
65-74 938 901 1839
>=75 1050 1077 2127
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3564 participants 3577 participants 7141 participants
Female
1197
  33.6%
1247
  34.9%
2444
  34.2%
Male
2367
  66.4%
2330
  65.1%
4697
  65.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3564 participants 3577 participants 7141 participants
ARG 108 108 216
AUS 18 16 34
BGR 35 32 67
BRA 73 77 150
CAN 240 236 476
CHL 25 25 50
CHN 154 160 314
COL 15 15 30
DEU 3 3 6
FRA 51 47 98
GRC 24 24 48
IND 499 502 1001
ISR 38 40 78
ITA 36 36 72
KOR 74 74 148
LTU 48 49 97
MEX 108 111 219
MYS 38 37 75
NLD 71 70 141
NOR 27 29 56
NZL 7 7 14
POL 134 133 267
ROU 24 28 52
RUS 148 147 295
SGP 27 26 53
SWE 2 3 5
THA 23 23 46
TWN 38 39 77
UKR 97 92 189
USA 1379 1388 2767
Baseline BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/cm2
Number Analyzed 3564 participants 3577 participants 7141 participants
28.9  (7.86) 29.1  (7.77) 29.0  (7.81)
1.Primary Outcome
Title Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality
Hide Description [Not Specified]
Time Frame Randomization to Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 141 and 164 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.
Arm/Group Title Nesiritide Placebo
Hide Arm/Group Description:
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Overall Number of Participants Analyzed 3423 3413
Measure Type: Number
Unit of Measure: Participants
321 345
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nesiritide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.313
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by geographical region.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-2.1 to 0.7
Estimation Comments [Not Specified]
2.Primary Outcome
Title Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug
Hide Description Dyspnea symptoms were measured by patient self-assessed Likert scale at 6 hours after study drug initiation.The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)
Time Frame 6 hours after initiation of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 148 and 133 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.
Arm/Group Title Nesiritide Placebo
Hide Arm/Group Description:
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Overall Number of Participants Analyzed 3416 3444
Measure Type: Number
Unit of Measure: Participants
Markedly Better 513 460
Moderately Better 1007 989
Minimally Better 1119 1174
No Change 692 748
Minimally Worse 39 40
Moderately Worse 12 13
Markedly Worse 34 20
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nesiritide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments [Not Specified]
Method Van Elteren test
Comments Controlled for region.
3.Primary Outcome
Title Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug
Hide Description Dyspnea symptoms were measured by patient self-assessed Likert scale at 24 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)
Time Frame 24 hours after study drug initiation
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 193 and 179 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.
Arm/Group Title Nesiritide Placebo
Hide Arm/Group Description:
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Overall Number of Participants Analyzed 3371 3398
Measure Type: Number
Unit of Measure: Participants
Markedly Better 1025 935
Moderately Better 1274 1313
Minimally Better 716 751
No Change 291 323
Minimally Worse 27 36
Moderately Worse 7 15
Markedly Worse 31 25
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nesiritide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Van Elteren test
Comments Controlled for region.
4.Secondary Outcome
Title Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug
Hide Description Overall well-being was measured by patient self-assessed Likert scale at 6 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)
Time Frame 6 hours after study drug initiation
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 158 and 147 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.
Arm/Group Title Nesiritide Placebo
Hide Arm/Group Description:
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Overall Number of Participants Analyzed 3406 3430
Measure Type: Number
Unit of Measure: Participants
Markedly Better 449 418
Moderately Better 962 965
Minimally Better 1154 1186
No Change 751 785
Minimally Worse 42 49
Moderately Worse 17 11
Markedly Worse 31 16
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nesiritide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.318
Comments [Not Specified]
Method Van Elteren test
Comments Controlled for region.
5.Secondary Outcome
Title Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug
Hide Description Overall well-being was measured by patient self-assessed Likert scale at 24 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)
Time Frame 24 hours after study drug initiation
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 200 and 194 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.
Arm/Group Title Nesiritide Placebo
Hide Arm/Group Description:
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Overall Number of Participants Analyzed 3364 3383
Measure Type: Number
Unit of Measure: Participants
Markedly Better 913 843
Moderately Better 1297 1311
Minimally Better 761 798
No Change 310 331
Minimally Worse 31 52
Moderately Worse 16 22
Markedly Worse 36 26
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nesiritide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments [Not Specified]
Method Van Elteren test
Comments Controlled for region.
6.Secondary Outcome
Title Composite of Persistent or Worsening Heart Failure and All-Cause Mortality
Hide Description Clinical manifestations of worsening or persistent decompensated heart failure were defined by at least one of the following: new, persistent or worsening: dyspnea, orthopnea, paroxysmal nocturnal dyspnea, edema, pulmonary basilar rales/crackles, jugular venous distension, renal hypoperfusion with no other apparent cause, or radiologic evidence of worsening heart failure. And was also defined by a new therapy specifically for the treatment of worsening or persistent decompensated heart failure.
Time Frame Randomization to hospital discharge (up to Day 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 105 and 115 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.
Arm/Group Title Nesiritide Placebo
Hide Arm/Group Description:
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Overall Number of Participants Analyzed 3459 3462
Measure Type: Number
Unit of Measure: Participants
147 165
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nesiritide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.295
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlled for region.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-1.5 to 0.5
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Days Alive and Outside the Hospital
Hide Description [Not Specified]
Time Frame Randomization to Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 182 and 188 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.
Arm/Group Title Nesiritide Placebo
Hide Arm/Group Description:
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Overall Number of Participants Analyzed 3382 3389
Mean (Standard Deviation)
Unit of Measure: Days
20.9  (6.88) 20.7  (7.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nesiritide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.160
Comments [Not Specified]
Method ANOVA
Comments Controlled for region.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.17
Estimation Comments This analysis excluded subjects who were lost to follow-up, or withdrawal of consent before Day 30, or whose Day 30 visit occurred prior to Day 30.
8.Secondary Outcome
Title Composite of Cardiovascular Rehospitalization and Cardiovascular Mortality
Hide Description [Not Specified]
Time Frame Randomization to Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 141 and 162 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.
Arm/Group Title Nesiritide Placebo
Hide Arm/Group Description:
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Overall Number of Participants Analyzed 3423 3415
Measure Type: Number
Unit of Measure: Participants
372 402
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nesiritide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.238
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlled for region.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-2.4 to 0.6
Estimation Comments For subjects with a Day 30 visit prior to Day 30, information from their Day 180 visit, if available, was used to impute the mortality and rehospitalization status at Day 30.
9.Other Pre-specified Outcome
Title All-Cause Mortality Through Day 30
Hide Description All deaths were adjudicated by an independent Clinical Events Committee.
Time Frame Randomization to Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population.
Arm/Group Title Nesiritide Placebo
Hide Arm/Group Description:
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Overall Number of Participants Analyzed 3498 3509
Measure Type: Number
Unit of Measure: Participants
126 141
10.Other Pre-specified Outcome
Title All-Cause Mortality Through Day 180
Hide Description All deaths were adjudicated by an independent Clinical Events Committee.
Time Frame Randomization to Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population.
Arm/Group Title Nesiritide Placebo
Hide Arm/Group Description:
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Overall Number of Participants Analyzed 3498 3509
Measure Type: Number
Unit of Measure: Participants
429 447
11.Other Pre-specified Outcome
Title Cardiovascular Mortality Through Day 30
Hide Description All deaths were adjudicated by an independent Clinical Events Committee (CEC) and the cardiovascular deaths were classified by the CEC based on the primary causes.
Time Frame Randomization to Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population.
Arm/Group Title Nesiritide Placebo
Hide Arm/Group Description:
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Overall Number of Participants Analyzed 3498 3509
Measure Type: Number
Unit of Measure: Participants
Total Cardiovascular Deaths 112 124
Worsening Heart Failure 68 80
Myocardial Infarction 4 0
Sudden Cardiac Death 20 23
Other Cardiovascular Cause 11 10
Presumed Cardiovascular Cause 9 11
12.Other Pre-specified Outcome
Title Number of Patients With Renal Impairment
Hide Description Renal impairment was defined as a greater than 25% decrease from baseline in the Modification of Diet in Renal Disease calculated glomerular filtration rate.
Time Frame Study drug initiation to Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population.
Arm/Group Title Nesiritide Placebo
Hide Arm/Group Description:
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Overall Number of Participants Analyzed 3498 3509
Measure Type: Number
Unit of Measure: Participants
1032 968
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nesiritide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.109
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlled for region.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.98 to 1.21
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nesiritide Placebo
Hide Arm/Group Description 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
All-Cause Mortality
Nesiritide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Nesiritide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   5/3498 (0.14%)   2/3509 (0.06%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Pulmonary Embolism * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Skin and subcutaneous tissue disorders     
Angioedema * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Vascular disorders     
Hypotension * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Ischaemic Stroke * 1  2/3498 (0.06%)  1/3509 (0.03%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nesiritide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   366/3498 (10.46%)   364/3509 (10.37%) 
Blood and lymphatic system disorders     
Anaemia * 1  2/3498 (0.06%)  4/3509 (0.11%) 
Leukocytosis * 1  0/3498 (0.00%)  2/3509 (0.06%) 
Thrombocytopenia * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Cardiac disorders     
Aortic Valve Stenosis * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Arrhythmia Supraventricular * 1  6/3498 (0.17%)  4/3509 (0.11%) 
Atrial Fibrillation * 1  46/3498 (1.32%)  33/3509 (0.94%) 
Atrial Flutter * 1  3/3498 (0.09%)  2/3509 (0.06%) 
Atrial Septal Defect * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Atrial Tachycardia * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Atrioventricular Block Complete * 1  1/3498 (0.03%)  1/3509 (0.03%) 
Bradycardia * 1  7/3498 (0.20%)  7/3509 (0.20%) 
Cardiac Arrest * 1  16/3498 (0.46%)  10/3509 (0.28%) 
Cardiac Tamponade * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Congestive Cardiomyopathy * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Electromechanical Dissociation * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Endocarditis * 1  2/3498 (0.06%)  1/3509 (0.03%) 
Fluid Overload * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Hepatic Congestion * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Ischaemic Cardiomyopathy * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Mitral Valve Incompetence * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Mitral Valve Prolapse * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Palpitations * 1  0/3498 (0.00%)  3/3509 (0.09%) 
Sinus Tachycardia * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Subacute Endocarditis * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Tachyarrhythmia * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Tachycardia * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Ventricular Arrhythmia * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Ventricular Extrasystoles * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Ventricular Fibrillation * 1  11/3498 (0.31%)  8/3509 (0.23%) 
Ventricular Septal Defect * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Ventricular Tachycardia * 1  23/3498 (0.66%)  30/3509 (0.85%) 
Endocrine disorders     
Carcinoid Tumour of the Appendix * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Diabetes Mellitus * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Diabetes Mellitus Inadequate Control * 1  1/3498 (0.03%)  1/3509 (0.03%) 
Diabetic Neuropathy * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Hyperglycaemia * 1  2/3498 (0.06%)  2/3509 (0.06%) 
Hypoglycaemia * 1  5/3498 (0.14%)  8/3509 (0.23%) 
Hypothyroidism * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Eye disorders     
Blindness Transient * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Vision Blurred * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Gastrointestinal disorders     
Abdominal Discomfort * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Abdominal Pain * 1  5/3498 (0.14%)  1/3509 (0.03%) 
Abdominal Pain Upper * 1  0/3498 (0.00%)  2/3509 (0.06%) 
Anal Abscess * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Appendicitis * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Constipation * 1  1/3498 (0.03%)  1/3509 (0.03%) 
Diarrhoea * 1  3/3498 (0.09%)  2/3509 (0.06%) 
Diverticulitis * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Diverticulum * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Dysphagia * 1  2/3498 (0.06%)  1/3509 (0.03%) 
Faeces Discoloured * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Gastric Ulcer * 1  1/3498 (0.03%)  1/3509 (0.03%) 
Gastritis * 1  1/3498 (0.03%)  1/3509 (0.03%) 
Gastroduodenitis * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Gastroenteritis * 1  3/3498 (0.09%)  2/3509 (0.06%) 
Gastroenteritis Viral * 1  0/3498 (0.00%)  2/3509 (0.06%) 
Gastrointestinal Erosion * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Gastrointestinal Obstruction * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Ileus * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Intestinal Obstruction * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Intestinal Perforation * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Nausea * 1  1/3498 (0.03%)  1/3509 (0.03%) 
Pancreatitis Chronic * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Rectal Abscess * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Small Intestinal Obstruction * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Umbilical Hernia, Obstructive * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Vomiting * 1  2/3498 (0.06%)  0/3509 (0.00%) 
General disorders     
Asthenia * 1  1/3498 (0.03%)  2/3509 (0.06%) 
Device Dislocation * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Device Related Infection * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Device Related Sepsis * 1  2/3498 (0.06%)  0/3509 (0.00%) 
Hypothermia * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Infusion Site Extravasation * 1  2/3498 (0.06%)  0/3509 (0.00%) 
Medical Device Complication * 1  1/3498 (0.03%)  1/3509 (0.03%) 
Pyrexia * 1  1/3498 (0.03%)  1/3509 (0.03%) 
Sudden Cardiac Death * 1  0/3498 (0.00%)  2/3509 (0.06%) 
Sudden Death * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Hepatobiliary disorders     
Cholecystitis * 1  2/3498 (0.06%)  0/3509 (0.00%) 
Cholecystitis Acute * 1  2/3498 (0.06%)  2/3509 (0.06%) 
Cholestasis * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Hepatic Cirrhosis * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Hepatic Encephalopathy * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Hepatic Failure * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Hepatic Function Abnormal * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Hepatocellular Injury * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Immune system disorders     
Guillain-Barre Syndrome * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Transfusion Reaction * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Infections and infestations     
Bacteraemia * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Enterococcal Bacteraemia * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Infection * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Postoperative Wound Infection * 1  2/3498 (0.06%)  0/3509 (0.00%) 
Sepsis * 1  6/3498 (0.17%)  5/3509 (0.14%) 
Staphylococcal Bacteraemia * 1  0/3498 (0.00%)  2/3509 (0.06%) 
Staphylococcal Infection * 1  3/3498 (0.09%)  0/3509 (0.00%) 
Staphylococcal Sepsis * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Streptococcal Sepsis * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Wound Infection * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Injury, poisoning and procedural complications     
Fall * 1  2/3498 (0.06%)  2/3509 (0.06%) 
Road Traffic Accident * 1  1/3498 (0.03%)  1/3509 (0.03%) 
Therapeutic Agent Toxicity * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Wound Dehiscence * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Investigations     
Antimicrobial Susceptibility Test Resistant * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Blood Creatinine Increased * 1  2/3498 (0.06%)  0/3509 (0.00%) 
Blood Glucose Increased * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Catheter Culture Positive * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Fibrin D Dimer Increased * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Gastric Ph Decreased * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Hepatic Enzyme Increased * 1  0/3498 (0.00%)  1/3509 (0.03%) 
International Normalised Ratio Increased * 1  0/3498 (0.00%)  2/3509 (0.06%) 
Prostatic Specific Antigen Increased * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Metabolism and nutrition disorders     
Dehydration * 1  5/3498 (0.14%)  6/3509 (0.17%) 
Gout * 1  2/3498 (0.06%)  2/3509 (0.06%) 
Hyperbilirubinaemia * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Hyperkalaemia * 1  5/3498 (0.14%)  4/3509 (0.11%) 
Hypokalaemia * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Hyponatraemia * 1  1/3498 (0.03%)  2/3509 (0.06%) 
Hypovolaemia * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Musculoskeletal and connective tissue disorders     
Arthritis Bacterial * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Hip Fracture * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Joint Sprain * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Lower Limb Fracture * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Monarthritis * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Musculoskeletal Pain * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Osteomyelitis * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Pain in Extremity * 1  2/3498 (0.06%)  1/3509 (0.03%) 
Patella Fracture * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Pelvic Fracture * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Soft Tissue Infection * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colonic Polyp * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Small Cell Carcinoma * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Nervous system disorders     
Confusional State * 1  4/3498 (0.11%)  2/3509 (0.06%) 
Convulsion * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Dyskinesia * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Epilepsy * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Headache * 1  1/3498 (0.03%)  2/3509 (0.06%) 
Loss of Consciousness * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Unresponsive to Stimuli * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Psychiatric disorders     
Acute Psychosis * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Alcohol Withdrawal Syndrome * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Delirium * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Failure to Thrive * 1  0/3498 (0.00%)  2/3509 (0.06%) 
Mental Status Changes * 1  4/3498 (0.11%)  1/3509 (0.03%) 
Renal and urinary disorders     
Azotaemia * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Bladder Neoplasm * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Cystitis * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Haematuria * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Renal Artery Stenosis * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Renal Colic * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Ureteric Haemorrhage * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Urinary Retention * 1  2/3498 (0.06%)  1/3509 (0.03%) 
Urinary Tract Infection * 1  1/3498 (0.03%)  7/3509 (0.20%) 
Urinary Tract Obstruction * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Urosepsis * 1  1/3498 (0.03%)  1/3509 (0.03%) 
Reproductive system and breast disorders     
Benign Prostatic Hyperplasia * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Breast Cancer * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Endometrial Cancer * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Orchitis * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute Pulmonary Oedema * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Acute Respiratory Failure * 1  2/3498 (0.06%)  0/3509 (0.00%) 
Asthma * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Bronchitis * 1  7/3498 (0.20%)  1/3509 (0.03%) 
Bronchitis Bacterial * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Chest Pain * 1  6/3498 (0.17%)  8/3509 (0.23%) 
Chronic Obstructive Pulmonary Disease * 1  6/3498 (0.17%)  3/3509 (0.09%) 
Dyspnoea * 1  2/3498 (0.06%)  2/3509 (0.06%) 
Eosinophilic Pneumonia * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Haemoptysis * 1  2/3498 (0.06%)  0/3509 (0.00%) 
Hypercapnia * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Hypoxia * 1  2/3498 (0.06%)  1/3509 (0.03%) 
Hypoxic Encephalopathy * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Idiopathic Pulmonary Fibrosis * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Infective Exacerbation of Chronic Obstructive Airways Disease * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Influenza * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Lobar Pneumonia * 1  2/3498 (0.06%)  1/3509 (0.03%) 
Lower Respiratory Tract Infection * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Lung Cancer Metastatic * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Lung Disorder * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Lung Infection * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Lung Neoplasm * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Lung Neoplasm Malignant * 1  1/3498 (0.03%)  1/3509 (0.03%) 
Mediastinitis * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Mediastinum Neoplasm * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Musculoskeletal Chest Pain * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Non-Cardiac Chest Pain * 1  1/3498 (0.03%)  3/3509 (0.09%) 
Pharyngitis * 1  2/3498 (0.06%)  0/3509 (0.00%) 
Pleural Effusion * 1  8/3498 (0.23%)  4/3509 (0.11%) 
Pneumonia * 1  22/3498 (0.63%)  18/3509 (0.51%) 
Pneumonia Aspiration * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Pneumonia Bacterial * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Pneumonia Mycoplasmal * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Pneumonia Staphylococcal * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Pneumothorax * 1  1/3498 (0.03%)  4/3509 (0.11%) 
Pulmonary Embolism * 1  6/3498 (0.17%)  4/3509 (0.11%) 
Pulmonary Fibrosis * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Pulmonary Hypertension * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Pulmonary Infarction * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Pulmonary Oedema * 1  0/3498 (0.00%)  2/3509 (0.06%) 
Respiratory Arrest * 1  2/3498 (0.06%)  2/3509 (0.06%) 
Respiratory Distress * 1  2/3498 (0.06%)  0/3509 (0.00%) 
Respiratory Failure * 1  2/3498 (0.06%)  9/3509 (0.26%) 
Respiratory Tract Infection * 1  0/3498 (0.00%)  2/3509 (0.06%) 
Stridor * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Upper Respiratory Tract Infection * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Skin and subcutaneous tissue disorders     
Acarodermatitis * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Angioedema * 1  0/3498 (0.00%)  2/3509 (0.06%) 
Cellulitis * 1  4/3498 (0.11%)  2/3509 (0.06%) 
Dermatitis Allergic * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Dermatitis Exfoliative * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Diabetic Foot * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Diabetic Foot Infection * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Gangrene * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Petechiae * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Pruritus * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Subcutaneous Haematoma * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Vascular disorders     
Abdominal Wall Haematoma * 1  0/3498 (0.00%)  2/3509 (0.06%) 
Acute Coronary Syndrome * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Angina Pectoris * 1  2/3498 (0.06%)  8/3509 (0.23%) 
Angina Unstable * 1  1/3498 (0.03%)  3/3509 (0.09%) 
Aortic Aneurysm * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Aortic Dissection * 1  2/3498 (0.06%)  0/3509 (0.00%) 
Aortic Stenosis * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Arterial Haemorrhage * 1  0/3498 (0.00%)  2/3509 (0.06%) 
Bleeding Varicose Vein * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Cardiogenic Shock * 1  14/3498 (0.40%)  16/3509 (0.46%) 
Catheter Site Haemorrhage * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Cerebellar Haemorrhage * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Cerebrovascular Accident * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Colitis Ischaemic * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Coronary Artery Disease * 1  1/3498 (0.03%)  5/3509 (0.14%) 
Deep Vein Thrombosis * 1  4/3498 (0.11%)  3/3509 (0.09%) 
Dizziness * 1  0/3498 (0.00%)  4/3509 (0.11%) 
Duodenal Ulcer Haemorrhage * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Embolic Stroke * 1  2/3498 (0.06%)  1/3509 (0.03%) 
Embolism * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Femoral Artery Occlusion * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Gastrointestinal Haemorrhage * 1  4/3498 (0.11%)  8/3509 (0.23%) 
Haematemesis * 1  2/3498 (0.06%)  0/3509 (0.00%) 
Haematoma * 1  1/3498 (0.03%)  1/3509 (0.03%) 
Haemorrhagic Anaemia * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Haemorrhagic Stroke * 1  3/3498 (0.09%)  4/3509 (0.11%) 
Haemorrhoidal Haemorrhage * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Hypertension * 1  2/3498 (0.06%)  1/3509 (0.03%) 
Hypertensive Crisis * 1  0/3498 (0.00%)  2/3509 (0.06%) 
Hypoperfusion * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Hypotension * 1  6/3498 (0.17%)  10/3509 (0.28%) 
Iliac Artery Embolism * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Iliac Artery Thrombosis * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Infusion Site Phlebitis * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Intracardiac Thrombus * 1  1/3498 (0.03%)  1/3509 (0.03%) 
Ischaemic Cerebral Infarction * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Ischaemic Hepatitis * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Ischaemic Stroke * 1  11/3498 (0.31%)  20/3509 (0.57%) 
Lower Gastrointestinal Haemorrhage * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Melaena * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Myocardial Infarction * 1  19/3498 (0.54%)  15/3509 (0.43%) 
Myocardial Ischaemia * 1  2/3498 (0.06%)  0/3509 (0.00%) 
Orthostatic Hypotension * 1  3/3498 (0.09%)  1/3509 (0.03%) 
Peptic Ulcer Haemorrhage * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Peripheral Embolism * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Peripheral Ischaemia * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Phlebitis * 1  1/3498 (0.03%)  1/3509 (0.03%) 
Post Procedural Haematoma * 1  0/3498 (0.00%)  2/3509 (0.06%) 
Post Procedural Haemorrhage * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Presyncope * 1  0/3498 (0.00%)  5/3509 (0.14%) 
Raynaud's Phenomenon * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Rectal Haemorrhage * 1  4/3498 (0.11%)  3/3509 (0.09%) 
Retroperitoneal Haemorrhage * 1  1/3498 (0.03%)  1/3509 (0.03%) 
Septic Shock * 1  3/3498 (0.09%)  3/3509 (0.09%) 
Shock * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Small Intestinal Haemorrhage * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Subarachnoid Haemorrhage * 1  1/3498 (0.03%)  0/3509 (0.00%) 
Syncope * 1  6/3498 (0.17%)  5/3509 (0.14%) 
Systemic Inflammatory Response Syndrome * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Thrombophlebitis Superficial * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Thrombosis * 1  0/3498 (0.00%)  1/3509 (0.03%) 
Transient Ischaemic Attack * 1  2/3498 (0.06%)  4/3509 (0.11%) 
Upper Gastrointestinal Haemorrhage * 1  4/3498 (0.11%)  2/3509 (0.06%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Only summary counts of deaths by group are provided for other pre-specified endpoints “All-cause mortality through Day 30” and “All-cause mortality through Day 180.” Formal statistical comparisons were not planned.
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 Executive and Steering Committees is responsible for the creation, review, and submission of publications and presentations after study completion. The Investigator agrees that all data are the property of the Sponsors and subject to confidentiality and use restrictions until results are presented in the public domain. Publications or presentations must be submitted to the Sponsors and necessary committees for review before publication, public dissemination, or review by a third-parties.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President, Franchise Development
Organization: Johnson & Johnson Pharmaceutical Research & Development, LLC
Phone: 610-651-6628
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
O'Connor CM, Starling RC, Hernandez AF, Armstrong PW, Dickstein K, Hasselblad V, Heizer GM, Komajda M, Massie BM, McMurray JJ, Nieminen MS, Reist CJ, Rouleau JL, Swedberg K, Adams KF Jr, Anker SD, Atar D, Battler A, Botero R, Bohidar NR, Butler J, Clausell N, Corbalán R, Costanzo MR, Dahlstrom U, Deckelbaum LI, Diaz R, Dunlap ME, Ezekowitz JA, Feldman D, Felker GM, Fonarow GC, Gennevois D, Gottlieb SS, Hill JA, Hollander JE, Howlett JG, Hudson MP, Kociol RD, Krum H, Laucevicius A, Levy WC, Méndez GF, Metra M, Mittal S, Oh BH, Pereira NL, Ponikowski P, Tang WH, Tanomsup S, Teerlink JR, Triposkiadis F, Troughton RW, Voors AA, Whellan DJ, Zannad F, Califf RM. Effect of nesiritide in patients with acute decompensated heart failure. N Engl J Med. 2011 Jul 7;365(1):32-43. doi: 10.1056/NEJMoa1100171. Erratum in: N Engl J Med. 2011 Aug 25;365(8):773. Wilson, W H [corrected to Tang, W H W].
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Responsible Party: Scios, Inc.
ClinicalTrials.gov Identifier: NCT00475852     History of Changes
Other Study ID Numbers: CR013954
ASCEND-HF ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, LLC )
A093 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, LLC )
NATRECORAHF3002 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, LLC )
First Submitted: May 18, 2007
First Posted: May 21, 2007
Results First Submitted: September 27, 2011
Results First Posted: May 10, 2012
Last Update Posted: March 8, 2013