Trial Outcomes & Findings for A Study of THR-184 in Patients at Risk of Developing Cardiac Surgery Associated-Acute Kidney Injury (CSA-AKI) (NCT NCT01830920)
NCT ID: NCT01830920
Last Updated: 2017-04-20
Results Overview
Acute kidney injury (AKI) is defined using the KDIGO criteria, in which AKI is defined as any of the following: * Increase in SCr by ≥0.3 mg/dl (≥26.5 µmol/l) within 48 hours; or * Increase in SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or * Urine volume \<0.5 ml/kg/h for 6 hours.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
452 participants
Primary outcome timeframe
7 days
Results posted on
2017-04-20
Participant Flow
Participant milestones
| Measure |
Placebo
An identical appearing placebo will be administered.
Placebo: A normal saline solution identical in appearance to the active drug solution
|
THR-184 Dose 1
THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 2
THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 3
THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 4
THR-184 initial pre-surgery high dose followed by (3) post surgery doses \~80% of the pre-surgery dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
126
|
46
|
48
|
125
|
107
|
|
Overall Study
Received Allocated Drug
|
115
|
45
|
47
|
119
|
105
|
|
Overall Study
COMPLETED
|
105
|
40
|
40
|
109
|
99
|
|
Overall Study
NOT COMPLETED
|
21
|
6
|
8
|
16
|
8
|
Reasons for withdrawal
| Measure |
Placebo
An identical appearing placebo will be administered.
Placebo: A normal saline solution identical in appearance to the active drug solution
|
THR-184 Dose 1
THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 2
THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 3
THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 4
THR-184 initial pre-surgery high dose followed by (3) post surgery doses \~80% of the pre-surgery dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
1
|
7
|
1
|
|
Overall Study
Death
|
3
|
3
|
5
|
4
|
4
|
|
Overall Study
Other
|
15
|
1
|
1
|
5
|
3
|
Baseline Characteristics
A Study of THR-184 in Patients at Risk of Developing Cardiac Surgery Associated-Acute Kidney Injury (CSA-AKI)
Baseline characteristics by cohort
| Measure |
Placebo
n=115 Participants
An identical appearing placebo will be administered.
Placebo: A normal saline solution identical in appearance to the active drug solution
|
THR-184 Dose 1
n=45 Participants
THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 2
n=47 Participants
THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 3
n=119 Participants
THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 4
n=105 Participants
THR-184 initial pre-surgery high dose followed by (3) post surgery doses \~80% of the pre-surgery dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
Total
n=431 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
71.5 years
n=5 Participants
|
68.8 years
n=7 Participants
|
72.7 years
n=5 Participants
|
72.5 years
n=4 Participants
|
70.0 years
n=21 Participants
|
71.3 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
148 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
283 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
105 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
95 Participants
n=21 Participants
|
394 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Region of Enrollment
Canada
|
46 participants
n=5 Participants
|
17 participants
n=7 Participants
|
27 participants
n=5 Participants
|
55 participants
n=4 Participants
|
55 participants
n=21 Participants
|
200 participants
n=10 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=5 Participants
|
28 participants
n=7 Participants
|
20 participants
n=5 Participants
|
64 participants
n=4 Participants
|
50 participants
n=21 Participants
|
231 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: Per Protocol Analysis set -
Acute kidney injury (AKI) is defined using the KDIGO criteria, in which AKI is defined as any of the following: * Increase in SCr by ≥0.3 mg/dl (≥26.5 µmol/l) within 48 hours; or * Increase in SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or * Urine volume \<0.5 ml/kg/h for 6 hours.
Outcome measures
| Measure |
Placebo
n=93 Participants
An identical appearing placebo will be administered.
Placebo: A normal saline solution identical in appearance to the active drug solution
|
THR-184 Dose 1
n=24 Participants
THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 2
n=29 Participants
THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 3
n=91 Participants
THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 4
n=71 Participants
THR-184 initial pre-surgery high dose followed by (3) post surgery doses \~80% of the pre-surgery dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
|---|---|---|---|---|---|
|
Incidence of Acute Kidney Injury (AKI)
|
73 Participants
|
18 Participants
|
22 Participants
|
71 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Per Protocol Analysis set
AKI is defined using the SCr-KDIGO criteria, defined as the following: * Increase in SCr by ≥0.3 mg/dl (≥26.5 µmol/l) within 48 hours; or * Increase in SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days.
Outcome measures
| Measure |
Placebo
n=93 Participants
An identical appearing placebo will be administered.
Placebo: A normal saline solution identical in appearance to the active drug solution
|
THR-184 Dose 1
n=24 Participants
THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 2
n=29 Participants
THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 3
n=91 Participants
THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 4
n=71 Participants
THR-184 initial pre-surgery high dose followed by (3) post surgery doses \~80% of the pre-surgery dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
|---|---|---|---|---|---|
|
Incidence of AKI
|
53 Participants
|
13 Participants
|
17 Participants
|
51 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Per Protocol Analysis set
AKI is defined using the KDIGO criteria, in which AKI is defined as any of the following: * Increase in SCr by ≥0.3 mg/dl (≥26.5 µmol/l) within 48 hours; or * Increase in SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or * Urine volume \<0.5 ml/kg/h for 6 hours. Staging of AKI is defined as the following: Stage 1: SCr 1.5 - 1.9 times baseline OR ≥0.3 mg/dL (≥26.5 µmol/L) increase, Urine output \<0.5 ml/kg/hr for 6-12 hours Stage 2: SCr 2.0-2.9 times baseline, Urine output \<0.5 ml/kg/h for ≥ 12 hours Stage 3: SCr 3.0 times baseline OR Increase in SCr to ≥5.0 mg/dL (≥353.6 µmol/L) OR Initiation of renal replacement therapy OR In patients \<18 years, decrease in eGFR to \<35 ml/min per 1.73 m\^2, Urine output \<0.3 ml/kg/h for ≥24 hours OR Anuria for ≥12 hours. No AKI is considered the best outcome, and Stage 3 the worst outcome.
Outcome measures
| Measure |
Placebo
n=93 Participants
An identical appearing placebo will be administered.
Placebo: A normal saline solution identical in appearance to the active drug solution
|
THR-184 Dose 1
n=24 Participants
THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 2
n=29 Participants
THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 3
n=91 Participants
THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 4
n=71 Participants
THR-184 initial pre-surgery high dose followed by (3) post surgery doses \~80% of the pre-surgery dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
|---|---|---|---|---|---|
|
Severity of AKI
No AKI
|
20 Participants
|
6 Participants
|
7 Participants
|
20 Participants
|
21 Participants
|
|
Severity of AKI
Stage I AKI
|
47 Participants
|
10 Participants
|
12 Participants
|
48 Participants
|
29 Participants
|
|
Severity of AKI
Stage II AKI
|
23 Participants
|
7 Participants
|
9 Participants
|
22 Participants
|
18 Participants
|
|
Severity of AKI
Stage III AKI
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 7 days OR up to discharge after surgeryPopulation: Per Protocol Analysis set
AKI is defined using the Scr-KDIGO criteria. Duration of AKI is defined as the number of days from start of AKI (SCr-KDIGO) where either SCr increase ≥ 0.3 mg/dL above pre-AKI reference point (if the value exists) or if SCr increase ≥1.5 times baseline or dialysis in the first 7 days up to discharge if prior to 7 days.
Outcome measures
| Measure |
Placebo
n=93 Participants
An identical appearing placebo will be administered.
Placebo: A normal saline solution identical in appearance to the active drug solution
|
THR-184 Dose 1
n=24 Participants
THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 2
n=29 Participants
THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 3
n=91 Participants
THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 4
n=71 Participants
THR-184 initial pre-surgery high dose followed by (3) post surgery doses \~80% of the pre-surgery dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
|---|---|---|---|---|---|
|
Duration of AKI
|
3.7 days
Standard Deviation 2.44
|
2.4 days
Standard Deviation 1.80
|
2.8 days
Standard Deviation 1.92
|
3.4 days
Standard Deviation 2.49
|
3.5 days
Standard Deviation 2.47
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 30Population: Per Protocol Analysis set
Sustained impaired renal function defined as a 35% increase in SCr from baseline at Day 30.
Outcome measures
| Measure |
Placebo
n=93 Participants
An identical appearing placebo will be administered.
Placebo: A normal saline solution identical in appearance to the active drug solution
|
THR-184 Dose 1
n=24 Participants
THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 2
n=29 Participants
THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 3
n=91 Participants
THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 4
n=71 Participants
THR-184 initial pre-surgery high dose followed by (3) post surgery doses \~80% of the pre-surgery dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
|---|---|---|---|---|---|
|
Composite of Death, Dialysis, or Sustained Impaired Renal Function
Subjects not meeting Endpoint
|
77 Participants
|
17 Participants
|
20 Participants
|
73 Participants
|
47 Participants
|
|
Composite of Death, Dialysis, or Sustained Impaired Renal Function
Subjects meeting Endpoint
|
11 Participants
|
4 Participants
|
5 Participants
|
11 Participants
|
12 Participants
|
|
Composite of Death, Dialysis, or Sustained Impaired Renal Function
Subjects excluded from measure
|
5 Participants
|
3 Participants
|
4 Participants
|
7 Participants
|
12 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 30Population: Per Protocol Analysis set
Sustained impaired renal function defined as a 35% increase in SCr from baseline at Day 30.
Outcome measures
| Measure |
Placebo
n=93 Participants
An identical appearing placebo will be administered.
Placebo: A normal saline solution identical in appearance to the active drug solution
|
THR-184 Dose 1
n=24 Participants
THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 2
n=29 Participants
THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 3
n=91 Participants
THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 4
n=71 Participants
THR-184 initial pre-surgery high dose followed by (3) post surgery doses \~80% of the pre-surgery dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
|---|---|---|---|---|---|
|
Composite of Death, Dialysis, or Sustained Impaired Renal Function
Subjects meeting Endpoint
|
14 Participants
|
5 Participants
|
4 Participants
|
9 Participants
|
16 Participants
|
|
Composite of Death, Dialysis, or Sustained Impaired Renal Function
Subjects not meeting Endpoint
|
59 Participants
|
13 Participants
|
15 Participants
|
65 Participants
|
55 Participants
|
|
Composite of Death, Dialysis, or Sustained Impaired Renal Function
Subjects excluded from measure
|
20 Participants
|
6 Participants
|
10 Participants
|
17 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 48 serious events
Other events: 112 other events
Deaths: 0 deaths
THR-184 Dose 1
Serious events: 21 serious events
Other events: 41 other events
Deaths: 0 deaths
THR-184 Dose 2
Serious events: 28 serious events
Other events: 46 other events
Deaths: 0 deaths
THR-184 Dose 3
Serious events: 50 serious events
Other events: 116 other events
Deaths: 0 deaths
THR-184 Dose 4
Serious events: 43 serious events
Other events: 103 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=115 participants at risk
An identical appearing placebo will be administered.
Placebo: A normal saline solution identical in appearance to the active drug solution
|
THR-184 Dose 1
n=45 participants at risk
THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 2
n=47 participants at risk
THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 3
n=119 participants at risk
THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 4
n=105 participants at risk
THR-184 initial pre-surgery high dose followed by (3) post surgery doses \~80% of the pre-surgery dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
6.1%
7/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.4%
3/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.4%
4/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.9%
3/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.4%
4/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Cardiac arrest
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.4%
2/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.3%
2/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Arrythmia
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.4%
2/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Atrioventricular block
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Torsade de pointes
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.9%
2/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Nodal rhythm
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Cardiac failure congestive
|
4.3%
5/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.3%
2/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.5%
3/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.8%
4/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Cardiogenic shock
|
3.5%
4/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.4%
2/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.3%
2/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.7%
2/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.9%
2/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Cardiac failure
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Low cardiac output syndrome
|
1.7%
2/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Pericardial effusion
|
1.7%
2/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.9%
2/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Cardiac tamponade
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Dressler's syndrome
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Myocardial infarction
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.7%
2/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Cardiomyopathy
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Myocardial rupture
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Systolic dysfunction
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.3%
5/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
10.6%
5/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
5.0%
6/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.9%
3/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.7%
2/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.4%
2/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.9%
3/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.3%
2/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.7%
2/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.9%
2/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal haemorrhage
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.7%
2/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Infections and infestations
Postoperative wound infection
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.8%
4/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Infections and infestations
Pneumonia
|
2.6%
3/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.9%
2/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Infections and infestations
Sepsis
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Infections and infestations
Septic shock
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Infections and infestations
Wound abscess
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Infections and infestations
Cellulitis
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Infections and infestations
Cystitis escherichia
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Infections and infestations
Endocarditis enterococcal
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Infections and infestations
Pseudomonas infection
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
2.6%
3/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.4%
3/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.7%
2/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Injury, poisoning and procedural complications
Cardiac valve replacement complication
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Injury, poisoning and procedural complications
Coronary vascular graft occlusion
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Injury, poisoning and procedural complications
Febrile nonhaemolytic transfusion reaction
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Injury, poisoning and procedural complications
Mechanical ventilation complication
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Injury, poisoning and procedural complications
Mental status changes postoperative
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Injury, poisoning and procedural complications
Post procedural stroke
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Injury, poisoning and procedural complications
Wound dishiscence
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.7%
2/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Nervous system disorders
Syncope
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Nervous system disorders
Neurological symptom
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Nervous system disorders
Coma
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Nervous system disorders
Stupor
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Nervous system disorders
Seizure
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.4%
4/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.8%
4/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Renal and urinary disorders
Renal failure
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.9%
2/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Vascular disorders
Hypotension
|
2.6%
3/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.9%
3/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Vascular disorders
Orthostatic hypotension
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Vascular disorders
Shock
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Vascular disorders
Haemodynamic instability
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Vascular disorders
Air embolism
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Vascular disorders
Hypertension
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
General disorders
Non-cardiac chest pain
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.7%
2/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
General disorders
Multi-organ failure
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
General disorders
Asthenia
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
General disorders
Pyrexia
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
General disorders
Device malfunction
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.4%
2/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Investigations
Transaminases increased
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Investigations
Haemoglobin decreased
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Hepatobiliary disorders
Hepatic congestion
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Psychiatric disorders
Confusional state
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Psychiatric disorders
Catatonia
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Eye disorders
Diplopia
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Eye disorders
Optic neuropathy
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Musculoskeletal and connective tissue disorders
Chrondocalcinosis pyrophosphate
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Surgical and medical procedures
Implantable defibrillator replacement
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Surgical and medical procedures
Wound drainage
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell carcinoma
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
Other adverse events
| Measure |
Placebo
n=115 participants at risk
An identical appearing placebo will be administered.
Placebo: A normal saline solution identical in appearance to the active drug solution
|
THR-184 Dose 1
n=45 participants at risk
THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 2
n=47 participants at risk
THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 3
n=119 participants at risk
THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
THR-184 Dose 4
n=105 participants at risk
THR-184 initial pre-surgery high dose followed by (3) post surgery doses \~80% of the pre-surgery dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Ventricular fibrillation
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.4%
2/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.4%
3/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.5%
3/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.9%
2/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
3/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.4%
3/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.9%
2/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Low cardiac output syndrome
|
9.6%
11/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
3/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.4%
3/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
5.9%
7/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.8%
4/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Pericardial disorders
|
5.2%
6/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
3/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
5.9%
7/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.9%
3/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Metabolism and nutrition disorders
Fluid overload
|
13.9%
16/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
26.7%
12/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
27.7%
13/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
25.2%
30/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
17.1%
18/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.0%
8/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
11.1%
5/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
10.6%
5/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
5.9%
7/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
5.7%
6/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.6%
11/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
24.4%
11/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
17.0%
8/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
12.6%
15/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
9.5%
10/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.3%
5/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
8.5%
4/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
5.9%
7/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.8%
4/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Vascular disorders
Hypertension
|
4.3%
5/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
8.9%
4/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
12.8%
6/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
7.6%
9/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.8%
5/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
5.0%
6/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.9%
3/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.9%
24/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
15.6%
7/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
14.9%
7/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
29.4%
35/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
13.3%
14/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
13.9%
16/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
20.0%
9/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
21.3%
10/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
22.7%
27/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
11.4%
12/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.1%
7/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
11.1%
5/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
8.5%
4/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
5.0%
6/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.8%
4/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.4%
12/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
13.3%
6/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
10.6%
5/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
14.3%
17/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
9.5%
10/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Metabolism and nutrition disorders
Acid-base disorders
|
2.6%
3/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.4%
2/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.4%
3/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.4%
4/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.2%
6/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.4%
2/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.3%
2/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.4%
4/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
7/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
5/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.4%
2/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
8/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.8%
5/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
3/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
5.0%
6/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.8%
4/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.6%
3/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
10.6%
5/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.5%
3/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.9%
3/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
7.8%
9/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
13.3%
6/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
14.9%
7/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
8.4%
10/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
7/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.6%
3/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
3/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.2%
5/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.8%
4/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
19.1%
22/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
20.0%
9/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
19.1%
9/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
28.6%
34/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
25.7%
27/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
4.3%
5/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
13.3%
6/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
8/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.8%
5/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
3.5%
4/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
8.5%
4/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.5%
3/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.9%
3/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Injury, poisoning and procedural complications
Wound complication
|
5.2%
6/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
8.9%
4/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.4%
3/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
5.0%
6/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
7/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Blood and lymphatic system disorders
Anaemia
|
29.6%
34/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
40.0%
18/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
27.7%
13/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
26.1%
31/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
23.8%
25/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.3%
13/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
24.4%
11/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
19.1%
9/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
14.3%
17/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
10.5%
11/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.2%
6/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
8.9%
4/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.4%
3/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
8/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.9%
3/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
4.3%
5/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.4%
3/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.4%
4/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.9%
2/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Gastrointestinal disorders
Nausea
|
20.9%
24/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
31.1%
14/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
19.1%
9/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
20.2%
24/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
23.8%
25/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Gastrointestinal disorders
Vomiting
|
3.5%
4/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
13.3%
6/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
8.5%
4/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.7%
2/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
7/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Gastrointestinal disorders
Constipation
|
16.5%
19/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
22.2%
10/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
8.5%
4/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
11.8%
14/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
10.5%
11/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Gastrointestinal disorders
Oral soft tissue conditions
|
0.00%
0/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.4%
3/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Vascular disorders
Hypotension
|
21.7%
25/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
17.8%
8/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
29.8%
14/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
17.6%
21/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
18.1%
19/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Vascular disorders
Vascular haemorrhagic disorders
|
4.3%
5/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.4%
2/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.4%
3/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.5%
3/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.9%
3/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
General disorders
Oedema peripheral
|
17.4%
20/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
15.6%
7/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
10.6%
5/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
11.8%
14/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
18.1%
19/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
General disorders
Asthenia
|
3.5%
4/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
8.9%
4/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.4%
4/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
General disorders
Secretion discharge
|
1.7%
2/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.4%
2/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.4%
3/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
General disorders
Body temperature conditions
|
5.2%
6/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.4%
2/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.4%
3/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.5%
3/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.9%
2/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Infections and infestations
Urinary tract infection
|
11.3%
13/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
15.6%
7/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.4%
3/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
8/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
10.5%
11/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Infections and infestations
Postoperative wound infection
|
3.5%
4/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
3/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.4%
4/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
11.4%
12/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Infections and infestations
Pneumonia
|
8.7%
10/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.3%
2/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.4%
4/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.8%
5/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Infections and infestations
Bacterial infectious disorders
|
7.0%
8/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
11.1%
5/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.4%
3/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
7.6%
9/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.8%
5/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Investigations
Haemoglobin decreased
|
5.2%
6/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.3%
2/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.4%
4/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
10.5%
11/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Investigations
Urine output decreased
|
3.5%
4/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
5.0%
6/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.9%
2/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Investigations
Blood creatinine increased
|
1.7%
2/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.4%
3/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.5%
3/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.8%
4/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Investigations
Cardiac and vascular investigations (excl. enzyme tests)
|
7.0%
8/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.4%
2/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.3%
2/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.4%
4/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
7.6%
8/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Investigations
Hepatobiliary investigations
|
2.6%
3/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
11.1%
5/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.3%
2/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
5.9%
7/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
7/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Investigations
Blood magnesium decreased
|
7.0%
8/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.4%
2/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.5%
3/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Investigations
Blood calcium decreased
|
1.7%
2/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
3/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.7%
2/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
3/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.3%
2/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.5%
3/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.9%
2/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Investigations
Protein and chemistry analyses NEC
|
4.3%
5/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
3/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.2%
5/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Investigations
Metabolic, nutritional and blood gas investigations
|
1.7%
2/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
3/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.4%
3/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.7%
2/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Renal and urinary disorders
Acute kidney injury
|
15.7%
18/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
28.9%
13/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
12.8%
6/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
19.3%
23/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
13.3%
14/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Renal and urinary disorders
Renal failure
|
3.5%
4/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.4%
2/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
8.5%
4/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.7%
2/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.8%
5/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Renal and urinary disorders
Urinary retention
|
6.1%
7/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.4%
4/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.9%
2/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Psychiatric disorders
Delirium
|
7.8%
9/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.4%
4/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
7/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Psychiatric disorders
Confusional state
|
4.3%
5/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
3/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.5%
3/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.8%
4/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Psychiatric disorders
Insomnia
|
3.5%
4/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
11.1%
5/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.5%
3/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
11.4%
12/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Psychiatric disorders
Agitation
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
3/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.3%
2/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.9%
3/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Nervous system disorders
Hypoaesthesia
|
2.6%
3/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
8.5%
4/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.7%
2/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Nervous system disorders
Central nervous system vascular disorders
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
11.1%
5/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.2%
5/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.95%
1/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.7%
2/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.4%
3/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.84%
1/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
3/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
11.1%
5/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.7%
2/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.9%
2/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Reproductive system and breast disorders
Penile and scrotal disorders (excl. infections and inflammations)
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
3/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.9%
2/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Surgical and medical procedures
Surgical and medical procedures
|
3.5%
4/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.2%
1/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
8.5%
4/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.7%
2/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
4.8%
5/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
2.6%
3/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
8.9%
4/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.5%
3/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
3.8%
4/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Atrioventricular block complete
|
1.7%
2/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.1%
1/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
6.7%
8/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
1.9%
2/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
|
Cardiac disorders
Arrhythmia
|
0.87%
1/115 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
8.9%
4/45 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
0.00%
0/47 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.5%
3/119 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
2.9%
3/105 • Data were collected over approximately 90 days post-cardiac surgery, with a 14 day Screening Period prior to surgery.
Systematic Assessment: each patient was evaluated at least once a day until day 7 post-surgery or until discharge from the hospital. Subjects returned for a follow-up visit on Day 30 and Day 90 and follow-up phone calls were conducted on Day 14 and Day 60.
|
Additional Information
Jerome Rossert, MD, PhD, Chief Scientific Officer
Thrasos Therapeutics, Inc.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place