Trial Outcomes & Findings for A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure (NCT NCT00475852)
NCT ID: NCT00475852
Last Updated: 2013-03-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
7141 participants
Primary outcome timeframe
Randomization to Day 30
Results posted on
2013-03-08
Participant Flow
Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure (ASCEND-HF)
Participant milestones
| Measure |
Nesiritide
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
Placebo
Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
|---|---|---|
|
Overall Study
STARTED
|
3564
|
3577
|
|
Overall Study
COMPLETED
|
3047
|
3029
|
|
Overall Study
NOT COMPLETED
|
517
|
548
|
Reasons for withdrawal
| Measure |
Nesiritide
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
Placebo
Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
|---|---|---|
|
Overall Study
Death
|
444
|
456
|
|
Overall Study
Withdrawal by Subject
|
19
|
24
|
|
Overall Study
Lost to Follow-up
|
54
|
68
|
Baseline Characteristics
A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure
Baseline characteristics by cohort
| Measure |
Nesiritide
n=3564 Participants
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
Placebo
n=3577 Participants
Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
Total
n=7141 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1572 Participants
n=5 Participants
|
1597 Participants
n=7 Participants
|
3169 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1988 Participants
n=5 Participants
|
1978 Participants
n=7 Participants
|
3966 Participants
n=5 Participants
|
|
Age Continuous
|
65.5 years
STANDARD_DEVIATION 14.09 • n=5 Participants
|
65.4 years
STANDARD_DEVIATION 14.20 • n=7 Participants
|
65.5 years
STANDARD_DEVIATION 14.14 • n=5 Participants
|
|
Age, Customized
<=64
|
1576 participants
n=5 Participants
|
1599 participants
n=7 Participants
|
3175 participants
n=5 Participants
|
|
Age, Customized
65-74
|
938 participants
n=5 Participants
|
901 participants
n=7 Participants
|
1839 participants
n=5 Participants
|
|
Age, Customized
>=75
|
1050 participants
n=5 Participants
|
1077 participants
n=7 Participants
|
2127 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1197 Participants
n=5 Participants
|
1247 Participants
n=7 Participants
|
2444 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2367 Participants
n=5 Participants
|
2330 Participants
n=7 Participants
|
4697 Participants
n=5 Participants
|
|
Region of Enrollment
ARG
|
108 participants
n=5 Participants
|
108 participants
n=7 Participants
|
216 participants
n=5 Participants
|
|
Region of Enrollment
AUS
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Region of Enrollment
BGR
|
35 participants
n=5 Participants
|
32 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Region of Enrollment
BRA
|
73 participants
n=5 Participants
|
77 participants
n=7 Participants
|
150 participants
n=5 Participants
|
|
Region of Enrollment
CAN
|
240 participants
n=5 Participants
|
236 participants
n=7 Participants
|
476 participants
n=5 Participants
|
|
Region of Enrollment
CHL
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Region of Enrollment
CHN
|
154 participants
n=5 Participants
|
160 participants
n=7 Participants
|
314 participants
n=5 Participants
|
|
Region of Enrollment
COL
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
DEU
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
FRA
|
51 participants
n=5 Participants
|
47 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
Region of Enrollment
GRC
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Region of Enrollment
IND
|
499 participants
n=5 Participants
|
502 participants
n=7 Participants
|
1001 participants
n=5 Participants
|
|
Region of Enrollment
ISR
|
38 participants
n=5 Participants
|
40 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Region of Enrollment
ITA
|
36 participants
n=5 Participants
|
36 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Region of Enrollment
KOR
|
74 participants
n=5 Participants
|
74 participants
n=7 Participants
|
148 participants
n=5 Participants
|
|
Region of Enrollment
LTU
|
48 participants
n=5 Participants
|
49 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Region of Enrollment
MEX
|
108 participants
n=5 Participants
|
111 participants
n=7 Participants
|
219 participants
n=5 Participants
|
|
Region of Enrollment
MYS
|
38 participants
n=5 Participants
|
37 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Region of Enrollment
NLD
|
71 participants
n=5 Participants
|
70 participants
n=7 Participants
|
141 participants
n=5 Participants
|
|
Region of Enrollment
NOR
|
27 participants
n=5 Participants
|
29 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Region of Enrollment
NZL
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
POL
|
134 participants
n=5 Participants
|
133 participants
n=7 Participants
|
267 participants
n=5 Participants
|
|
Region of Enrollment
ROU
|
24 participants
n=5 Participants
|
28 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Region of Enrollment
RUS
|
148 participants
n=5 Participants
|
147 participants
n=7 Participants
|
295 participants
n=5 Participants
|
|
Region of Enrollment
SGP
|
27 participants
n=5 Participants
|
26 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Region of Enrollment
SWE
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
THA
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Region of Enrollment
TWN
|
38 participants
n=5 Participants
|
39 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Region of Enrollment
UKR
|
97 participants
n=5 Participants
|
92 participants
n=7 Participants
|
189 participants
n=5 Participants
|
|
Region of Enrollment
USA
|
1379 participants
n=5 Participants
|
1388 participants
n=7 Participants
|
2767 participants
n=5 Participants
|
|
Baseline BMI
|
28.9 kg/cm2
STANDARD_DEVIATION 7.86 • n=5 Participants
|
29.1 kg/cm2
STANDARD_DEVIATION 7.77 • n=7 Participants
|
29.0 kg/cm2
STANDARD_DEVIATION 7.81 • n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization to Day 30Population: 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.
Outcome measures
| Measure |
Nesiritide
n=3423 Participants
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
Placebo
n=3413 Participants
Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
|---|---|---|
|
Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality
|
321 Participants
|
345 Participants
|
PRIMARY outcome
Timeframe: 6 hours after initiation of study drugPopulation: 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.
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.)
Outcome measures
| Measure |
Nesiritide
n=3416 Participants
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
Placebo
n=3444 Participants
Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
|---|---|---|
|
Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug
Markedly Better
|
513 Participants
|
460 Participants
|
|
Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug
Moderately Better
|
1007 Participants
|
989 Participants
|
|
Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug
Minimally Better
|
1119 Participants
|
1174 Participants
|
|
Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug
No Change
|
692 Participants
|
748 Participants
|
|
Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug
Minimally Worse
|
39 Participants
|
40 Participants
|
|
Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug
Moderately Worse
|
12 Participants
|
13 Participants
|
|
Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug
Markedly Worse
|
34 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: 24 hours after study drug initiationPopulation: 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.
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.)
Outcome measures
| Measure |
Nesiritide
n=3371 Participants
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
Placebo
n=3398 Participants
Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
|---|---|---|
|
Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug
Markedly Better
|
1025 Participants
|
935 Participants
|
|
Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug
Moderately Better
|
1274 Participants
|
1313 Participants
|
|
Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug
Minimally Better
|
716 Participants
|
751 Participants
|
|
Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug
No Change
|
291 Participants
|
323 Participants
|
|
Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug
Minimally Worse
|
27 Participants
|
36 Participants
|
|
Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug
Moderately Worse
|
7 Participants
|
15 Participants
|
|
Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug
Markedly Worse
|
31 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 6 hours after study drug initiationPopulation: 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.
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.)
Outcome measures
| Measure |
Nesiritide
n=3406 Participants
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
Placebo
n=3430 Participants
Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
|---|---|---|
|
Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug
Markedly Better
|
449 Participants
|
418 Participants
|
|
Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug
Moderately Better
|
962 Participants
|
965 Participants
|
|
Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug
Minimally Better
|
1154 Participants
|
1186 Participants
|
|
Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug
No Change
|
751 Participants
|
785 Participants
|
|
Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug
Minimally Worse
|
42 Participants
|
49 Participants
|
|
Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug
Moderately Worse
|
17 Participants
|
11 Participants
|
|
Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug
Markedly Worse
|
31 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 24 hours after study drug initiationPopulation: 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.
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.)
Outcome measures
| Measure |
Nesiritide
n=3364 Participants
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
Placebo
n=3383 Participants
Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
|---|---|---|
|
Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug
Markedly Better
|
913 Participants
|
843 Participants
|
|
Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug
Moderately Better
|
1297 Participants
|
1311 Participants
|
|
Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug
Minimally Better
|
761 Participants
|
798 Participants
|
|
Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug
No Change
|
310 Participants
|
331 Participants
|
|
Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug
Minimally Worse
|
31 Participants
|
52 Participants
|
|
Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug
Moderately Worse
|
16 Participants
|
22 Participants
|
|
Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug
Markedly Worse
|
36 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Randomization to hospital discharge (up to Day 30)Population: 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.
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.
Outcome measures
| Measure |
Nesiritide
n=3459 Participants
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
Placebo
n=3462 Participants
Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
|---|---|---|
|
Composite of Persistent or Worsening Heart Failure and All-Cause Mortality
|
147 Participants
|
165 Participants
|
SECONDARY outcome
Timeframe: Randomization to Day 30Population: 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.
Outcome measures
| Measure |
Nesiritide
n=3382 Participants
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
Placebo
n=3389 Participants
Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
|---|---|---|
|
Number of Days Alive and Outside the Hospital
|
20.9 Days
Standard Deviation 6.88
|
20.7 Days
Standard Deviation 7.05
|
SECONDARY outcome
Timeframe: Randomization to Day 30Population: 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.
Outcome measures
| Measure |
Nesiritide
n=3423 Participants
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
Placebo
n=3415 Participants
Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
|---|---|---|
|
Composite of Cardiovascular Rehospitalization and Cardiovascular Mortality
|
372 Participants
|
402 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomization to Day 30Population: 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.
All deaths were adjudicated by an independent Clinical Events Committee.
Outcome measures
| Measure |
Nesiritide
n=3498 Participants
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
Placebo
n=3509 Participants
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 Through Day 30
|
126 Participants
|
141 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomization to Day 180Population: 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.
All deaths were adjudicated by an independent Clinical Events Committee.
Outcome measures
| Measure |
Nesiritide
n=3498 Participants
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
Placebo
n=3509 Participants
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 Through Day 180
|
429 Participants
|
447 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomization to Day 30Population: 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.
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.
Outcome measures
| Measure |
Nesiritide
n=3498 Participants
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
Placebo
n=3509 Participants
Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
|---|---|---|
|
Cardiovascular Mortality Through Day 30
Total Cardiovascular Deaths
|
112 Participants
|
124 Participants
|
|
Cardiovascular Mortality Through Day 30
Worsening Heart Failure
|
68 Participants
|
80 Participants
|
|
Cardiovascular Mortality Through Day 30
Myocardial Infarction
|
4 Participants
|
0 Participants
|
|
Cardiovascular Mortality Through Day 30
Sudden Cardiac Death
|
20 Participants
|
23 Participants
|
|
Cardiovascular Mortality Through Day 30
Other Cardiovascular Cause
|
11 Participants
|
10 Participants
|
|
Cardiovascular Mortality Through Day 30
Presumed Cardiovascular Cause
|
9 Participants
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Study drug initiation to Day 30Population: 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.
Renal impairment was defined as a greater than 25% decrease from baseline in the Modification of Diet in Renal Disease calculated glomerular filtration rate.
Outcome measures
| Measure |
Nesiritide
n=3498 Participants
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
Placebo
n=3509 Participants
Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
|---|---|---|
|
Number of Patients With Renal Impairment
|
1032 Participants
|
968 Participants
|
Adverse Events
Nesiritide
Serious events: 5 serious events
Other events: 366 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 364 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nesiritide
n=3498 participants at risk
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
Placebo
n=3509 participants at risk
Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Vascular disorders
Hypotension
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Vascular disorders
Ischaemic Stroke
|
0.06%
2/3498
|
0.03%
1/3509
|
Other adverse events
| Measure |
Nesiritide
n=3498 participants at risk
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
Placebo
n=3509 participants at risk
Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
|
|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.03%
1/3498
|
0.03%
1/3509
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.09%
3/3498
|
0.06%
2/3509
|
|
Gastrointestinal disorders
Gastroenteritis Viral
|
0.00%
0/3498
|
0.06%
2/3509
|
|
Gastrointestinal disorders
Gastrointestinal Erosion
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Gastrointestinal disorders
Gastrointestinal Obstruction
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Gastrointestinal disorders
Nausea
|
0.03%
1/3498
|
0.03%
1/3509
|
|
Gastrointestinal disorders
Pancreatitis Chronic
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Gastrointestinal disorders
Rectal Abscess
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Gastrointestinal disorders
Umbilical Hernia, Obstructive
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Gastrointestinal disorders
Vomiting
|
0.06%
2/3498
|
0.00%
0/3509
|
|
General disorders
Asthenia
|
0.03%
1/3498
|
0.06%
2/3509
|
|
General disorders
Device Dislocation
|
0.00%
0/3498
|
0.03%
1/3509
|
|
General disorders
Device Related Infection
|
0.03%
1/3498
|
0.00%
0/3509
|
|
General disorders
Device Related Sepsis
|
0.06%
2/3498
|
0.00%
0/3509
|
|
General disorders
Hypothermia
|
0.00%
0/3498
|
0.03%
1/3509
|
|
General disorders
Infusion Site Extravasation
|
0.06%
2/3498
|
0.00%
0/3509
|
|
General disorders
Medical Device Complication
|
0.03%
1/3498
|
0.03%
1/3509
|
|
General disorders
Pyrexia
|
0.03%
1/3498
|
0.03%
1/3509
|
|
General disorders
Sudden Cardiac Death
|
0.00%
0/3498
|
0.06%
2/3509
|
|
General disorders
Sudden Death
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Hepatobiliary disorders
Cholecystitis
|
0.06%
2/3498
|
0.00%
0/3509
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.06%
2/3498
|
0.06%
2/3509
|
|
Hepatobiliary disorders
Cholestasis
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Hepatobiliary disorders
Hepatic Encephalopathy
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Hepatobiliary disorders
Hepatocellular Injury
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Immune system disorders
Guillain-Barre Syndrome
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Immune system disorders
Transfusion Reaction
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Infections and infestations
Enterococcal Bacteraemia
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Infections and infestations
Infection
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Infections and infestations
Postoperative Wound Infection
|
0.06%
2/3498
|
0.00%
0/3509
|
|
Blood and lymphatic system disorders
Anaemia
|
0.06%
2/3498
|
0.11%
4/3509
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3498
|
0.06%
2/3509
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Cardiac disorders
Arrhythmia Supraventricular
|
0.17%
6/3498
|
0.11%
4/3509
|
|
Cardiac disorders
Atrial Fibrillation
|
1.3%
46/3498
|
0.94%
33/3509
|
|
Cardiac disorders
Atrial Flutter
|
0.09%
3/3498
|
0.06%
2/3509
|
|
Cardiac disorders
Atrial Septal Defect
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Cardiac disorders
Atrial Tachycardia
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.03%
1/3498
|
0.03%
1/3509
|
|
Cardiac disorders
Bradycardia
|
0.20%
7/3498
|
0.20%
7/3509
|
|
Cardiac disorders
Cardiac Arrest
|
0.46%
16/3498
|
0.28%
10/3509
|
|
Cardiac disorders
Cardiac Tamponade
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Cardiac disorders
Congestive Cardiomyopathy
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Cardiac disorders
Electromechanical Dissociation
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Cardiac disorders
Endocarditis
|
0.06%
2/3498
|
0.03%
1/3509
|
|
Cardiac disorders
Fluid Overload
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Cardiac disorders
Hepatic Congestion
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Cardiac disorders
Mitral Valve Prolapse
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3498
|
0.09%
3/3509
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Cardiac disorders
Subacute Endocarditis
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Cardiac disorders
Tachyarrhythmia
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.31%
11/3498
|
0.23%
8/3509
|
|
Cardiac disorders
Ventricular Septal Defect
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.66%
23/3498
|
0.85%
30/3509
|
|
Endocrine disorders
Carcinoid Tumour of the Appendix
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Endocrine disorders
Diabetes Mellitus
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Endocrine disorders
Diabetes Mellitus Inadequate Control
|
0.03%
1/3498
|
0.03%
1/3509
|
|
Endocrine disorders
Diabetic Neuropathy
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Endocrine disorders
Hyperglycaemia
|
0.06%
2/3498
|
0.06%
2/3509
|
|
Endocrine disorders
Hypoglycaemia
|
0.14%
5/3498
|
0.23%
8/3509
|
|
Endocrine disorders
Hypothyroidism
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Eye disorders
Blindness Transient
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Eye disorders
Vision Blurred
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.14%
5/3498
|
0.03%
1/3509
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/3498
|
0.06%
2/3509
|
|
Gastrointestinal disorders
Anal Abscess
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Gastrointestinal disorders
Appendicitis
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Gastrointestinal disorders
Constipation
|
0.03%
1/3498
|
0.03%
1/3509
|
|
Gastrointestinal disorders
Diarrhoea
|
0.09%
3/3498
|
0.06%
2/3509
|
|
Gastrointestinal disorders
Diverticulitis
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Gastrointestinal disorders
Dysphagia
|
0.06%
2/3498
|
0.03%
1/3509
|
|
Gastrointestinal disorders
Faeces Discoloured
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.03%
1/3498
|
0.03%
1/3509
|
|
Infections and infestations
Sepsis
|
0.17%
6/3498
|
0.14%
5/3509
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.00%
0/3498
|
0.06%
2/3509
|
|
Infections and infestations
Staphylococcal Infection
|
0.09%
3/3498
|
0.00%
0/3509
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Infections and infestations
Streptococcal Sepsis
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Infections and infestations
Wound Infection
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Injury, poisoning and procedural complications
Fall
|
0.06%
2/3498
|
0.06%
2/3509
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.03%
1/3498
|
0.03%
1/3509
|
|
Injury, poisoning and procedural complications
Therapeutic Agent Toxicity
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Investigations
Antimicrobial Susceptibility Test Resistant
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Investigations
Blood Creatinine Increased
|
0.06%
2/3498
|
0.00%
0/3509
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Investigations
Catheter Culture Positive
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Investigations
Fibrin D Dimer Increased
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Investigations
Gastric Ph Decreased
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/3498
|
0.06%
2/3509
|
|
Investigations
Prostatic Specific Antigen Increased
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Metabolism and nutrition disorders
Dehydration
|
0.14%
5/3498
|
0.17%
6/3509
|
|
Metabolism and nutrition disorders
Gout
|
0.06%
2/3498
|
0.06%
2/3509
|
|
Metabolism and nutrition disorders
Hyperbilirubinaemia
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.14%
5/3498
|
0.11%
4/3509
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.03%
1/3498
|
0.06%
2/3509
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Musculoskeletal and connective tissue disorders
Arthritis Bacterial
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Musculoskeletal and connective tissue disorders
Hip Fracture
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Musculoskeletal and connective tissue disorders
Joint Sprain
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Musculoskeletal and connective tissue disorders
Lower Limb Fracture
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.06%
2/3498
|
0.03%
1/3509
|
|
Musculoskeletal and connective tissue disorders
Patella Fracture
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Musculoskeletal and connective tissue disorders
Pelvic Fracture
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Musculoskeletal and connective tissue disorders
Soft Tissue Infection
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colonic Polyp
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Carcinoma
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Nervous system disorders
Confusional State
|
0.11%
4/3498
|
0.06%
2/3509
|
|
Nervous system disorders
Convulsion
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Nervous system disorders
Headache
|
0.03%
1/3498
|
0.06%
2/3509
|
|
Nervous system disorders
Loss of Consciousness
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Nervous system disorders
Unresponsive to Stimuli
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Psychiatric disorders
Acute Psychosis
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Psychiatric disorders
Alcohol Withdrawal Syndrome
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Psychiatric disorders
Delirium
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Psychiatric disorders
Failure to Thrive
|
0.00%
0/3498
|
0.06%
2/3509
|
|
Psychiatric disorders
Mental Status Changes
|
0.11%
4/3498
|
0.03%
1/3509
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Renal and urinary disorders
Bladder Neoplasm
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Renal and urinary disorders
Cystitis
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Renal and urinary disorders
Renal Colic
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Renal and urinary disorders
Ureteric Haemorrhage
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Renal and urinary disorders
Urinary Retention
|
0.06%
2/3498
|
0.03%
1/3509
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.03%
1/3498
|
0.20%
7/3509
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Renal and urinary disorders
Urosepsis
|
0.03%
1/3498
|
0.03%
1/3509
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Reproductive system and breast disorders
Breast Cancer
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Reproductive system and breast disorders
Endometrial Cancer
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Reproductive system and breast disorders
Orchitis
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.06%
2/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.20%
7/3498
|
0.03%
1/3509
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Bacterial
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
0.17%
6/3498
|
0.23%
8/3509
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.17%
6/3498
|
0.09%
3/3509
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.06%
2/3498
|
0.06%
2/3509
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic Pneumonia
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.06%
2/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.06%
2/3498
|
0.03%
1/3509
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxic Encephalopathy
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic Pulmonary Fibrosis
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Respiratory, thoracic and mediastinal disorders
Infective Exacerbation of Chronic Obstructive Airways Disease
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Respiratory, thoracic and mediastinal disorders
Lobar Pneumonia
|
0.06%
2/3498
|
0.03%
1/3509
|
|
Respiratory, thoracic and mediastinal disorders
Lower Respiratory Tract Infection
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Lung Cancer Metastatic
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Lung Neoplasm
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Lung Neoplasm Malignant
|
0.03%
1/3498
|
0.03%
1/3509
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinitis
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinum Neoplasm
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Musculoskeletal Chest Pain
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Non-Cardiac Chest Pain
|
0.03%
1/3498
|
0.09%
3/3509
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.06%
2/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.23%
8/3498
|
0.11%
4/3509
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.63%
22/3498
|
0.51%
18/3509
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Bacterial
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Mycoplasmal
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Staphylococcal
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.03%
1/3498
|
0.11%
4/3509
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.17%
6/3498
|
0.11%
4/3509
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Infarction
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/3498
|
0.06%
2/3509
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.06%
2/3498
|
0.06%
2/3509
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.06%
2/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.06%
2/3498
|
0.26%
9/3509
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Infection
|
0.00%
0/3498
|
0.06%
2/3509
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Skin and subcutaneous tissue disorders
Acarodermatitis
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/3498
|
0.06%
2/3509
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.11%
4/3498
|
0.06%
2/3509
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Skin and subcutaneous tissue disorders
Dermatitis Exfoliative
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Skin and subcutaneous tissue disorders
Diabetic Foot
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Skin and subcutaneous tissue disorders
Diabetic Foot Infection
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Skin and subcutaneous tissue disorders
Gangrene
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Skin and subcutaneous tissue disorders
Subcutaneous Haematoma
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Vascular disorders
Abdominal Wall Haematoma
|
0.00%
0/3498
|
0.06%
2/3509
|
|
Vascular disorders
Acute Coronary Syndrome
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Vascular disorders
Angina Pectoris
|
0.06%
2/3498
|
0.23%
8/3509
|
|
Vascular disorders
Angina Unstable
|
0.03%
1/3498
|
0.09%
3/3509
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Vascular disorders
Aortic Dissection
|
0.06%
2/3498
|
0.00%
0/3509
|
|
Vascular disorders
Aortic Stenosis
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Vascular disorders
Arterial Haemorrhage
|
0.00%
0/3498
|
0.06%
2/3509
|
|
Vascular disorders
Bleeding Varicose Vein
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Vascular disorders
Cardiogenic Shock
|
0.40%
14/3498
|
0.46%
16/3509
|
|
Vascular disorders
Catheter Site Haemorrhage
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Vascular disorders
Cerebellar Haemorrhage
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Vascular disorders
Cerebrovascular Accident
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Vascular disorders
Colitis Ischaemic
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Vascular disorders
Coronary Artery Disease
|
0.03%
1/3498
|
0.14%
5/3509
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.11%
4/3498
|
0.09%
3/3509
|
|
Vascular disorders
Dizziness
|
0.00%
0/3498
|
0.11%
4/3509
|
|
Vascular disorders
Duodenal Ulcer Haemorrhage
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Vascular disorders
Embolic Stroke
|
0.06%
2/3498
|
0.03%
1/3509
|
|
Vascular disorders
Embolism
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Vascular disorders
Femoral Artery Occlusion
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Vascular disorders
Gastrointestinal Haemorrhage
|
0.11%
4/3498
|
0.23%
8/3509
|
|
Vascular disorders
Haematemesis
|
0.06%
2/3498
|
0.00%
0/3509
|
|
Vascular disorders
Haematoma
|
0.03%
1/3498
|
0.03%
1/3509
|
|
Vascular disorders
Haemorrhagic Anaemia
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Vascular disorders
Haemorrhagic Stroke
|
0.09%
3/3498
|
0.11%
4/3509
|
|
Vascular disorders
Haemorrhoidal Haemorrhage
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Vascular disorders
Hypertension
|
0.06%
2/3498
|
0.03%
1/3509
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/3498
|
0.06%
2/3509
|
|
Vascular disorders
Hypoperfusion
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Vascular disorders
Hypotension
|
0.17%
6/3498
|
0.28%
10/3509
|
|
Vascular disorders
Iliac Artery Embolism
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Vascular disorders
Iliac Artery Thrombosis
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Vascular disorders
Infusion Site Phlebitis
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Vascular disorders
Intracardiac Thrombus
|
0.03%
1/3498
|
0.03%
1/3509
|
|
Vascular disorders
Ischaemic Cerebral Infarction
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Vascular disorders
Ischaemic Hepatitis
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Vascular disorders
Ischaemic Stroke
|
0.31%
11/3498
|
0.57%
20/3509
|
|
Vascular disorders
Lower Gastrointestinal Haemorrhage
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Vascular disorders
Melaena
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Vascular disorders
Myocardial Infarction
|
0.54%
19/3498
|
0.43%
15/3509
|
|
Vascular disorders
Myocardial Ischaemia
|
0.06%
2/3498
|
0.00%
0/3509
|
|
Vascular disorders
Orthostatic Hypotension
|
0.09%
3/3498
|
0.03%
1/3509
|
|
Vascular disorders
Peptic Ulcer Haemorrhage
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Vascular disorders
Peripheral Embolism
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Vascular disorders
Peripheral Ischaemia
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Vascular disorders
Phlebitis
|
0.03%
1/3498
|
0.03%
1/3509
|
|
Vascular disorders
Post Procedural Haematoma
|
0.00%
0/3498
|
0.06%
2/3509
|
|
Vascular disorders
Post Procedural Haemorrhage
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Vascular disorders
Presyncope
|
0.00%
0/3498
|
0.14%
5/3509
|
|
Vascular disorders
Raynaud's Phenomenon
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Vascular disorders
Rectal Haemorrhage
|
0.11%
4/3498
|
0.09%
3/3509
|
|
Vascular disorders
Retroperitoneal Haemorrhage
|
0.03%
1/3498
|
0.03%
1/3509
|
|
Vascular disorders
Septic Shock
|
0.09%
3/3498
|
0.09%
3/3509
|
|
Vascular disorders
Shock
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Vascular disorders
Small Intestinal Haemorrhage
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Vascular disorders
Subarachnoid Haemorrhage
|
0.03%
1/3498
|
0.00%
0/3509
|
|
Vascular disorders
Syncope
|
0.17%
6/3498
|
0.14%
5/3509
|
|
Vascular disorders
Systemic Inflammatory Response Syndrome
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3498
|
0.03%
1/3509
|
|
Vascular disorders
Transient Ischaemic Attack
|
0.06%
2/3498
|
0.11%
4/3509
|
|
Vascular disorders
Upper Gastrointestinal Haemorrhage
|
0.11%
4/3498
|
0.06%
2/3509
|
Additional Information
Vice President, Franchise Development
Johnson & Johnson Pharmaceutical Research & Development, LLC
Phone: 610-651-6628
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER