Trial Outcomes & Findings for Post-Myocardial Infarction Remodeling Prevention Therapy (NCT NCT01213251)
NCT ID: NCT01213251
Last Updated: 2016-12-15
Results Overview
Left ventricular end diastolic volume (LVEDV) was measured by echocardiogram. Change was measured as Month 18 LVEDV minus baseline LVEDV. Per protocol, change in LVEDV is compared between Pooled Pacing (Single site + Dual Site) and Control.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
129 participants
Primary outcome timeframe
Baseline - 18 Month Follow Up Visit
Results posted on
2016-12-15
Participant Flow
3 patients exited study prior to randomization.
Participant milestones
| Measure |
Single Site Pacing
Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
|
Dual Site Pacing
Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
|
Control
Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
41
|
45
|
|
Overall Study
COMPLETED
|
34
|
37
|
34
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
11
|
Reasons for withdrawal
| Measure |
Single Site Pacing
Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
|
Dual Site Pacing
Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
|
Control
Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
|
|---|---|---|---|
|
Overall Study
Death
|
2
|
1
|
2
|
|
Overall Study
Exit
|
3
|
2
|
8
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
|
Overall Study
Missed 18-Month Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
Post-Myocardial Infarction Remodeling Prevention Therapy
Baseline characteristics by cohort
| Measure |
Single Site Pacing
n=40 Participants
Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
|
Dual Site Pacing
n=41 Participants
Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
|
Control
n=45 Participants
Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 10 • n=5 Participants
|
60 years
STANDARD_DEVIATION 12 • n=7 Participants
|
54 years
STANDARD_DEVIATION 11 • n=5 Participants
|
58 years
STANDARD_DEVIATION 11 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
19 participants
n=5 Participants
|
16 participants
n=7 Participants
|
18 participants
n=5 Participants
|
53 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not reportable per local laws or regulations
|
18 participants
n=5 Participants
|
20 participants
n=7 Participants
|
19 participants
n=5 Participants
|
57 participants
n=4 Participants
|
|
BMI (kg/m^2)
|
28 kg/m^2
STANDARD_DEVIATION 6 • n=5 Participants
|
30 kg/m^2
STANDARD_DEVIATION 5 • n=7 Participants
|
29 kg/m^2
STANDARD_DEVIATION 4 • n=5 Participants
|
29 kg/m^2
STANDARD_DEVIATION 5 • n=4 Participants
|
|
Systolic Blood Pressure (mmHg)
|
114 mmHg
STANDARD_DEVIATION 16 • n=5 Participants
|
118 mmHg
STANDARD_DEVIATION 21 • n=7 Participants
|
119 mmHg
STANDARD_DEVIATION 17 • n=5 Participants
|
117 mmHg
STANDARD_DEVIATION 18 • n=4 Participants
|
|
Diastolic Blood Pressure (mmHg)
|
73 mmHg
STANDARD_DEVIATION 11 • n=5 Participants
|
71 mmHg
STANDARD_DEVIATION 12 • n=7 Participants
|
74 mmHg
STANDARD_DEVIATION 11 • n=5 Participants
|
73 mmHg
STANDARD_DEVIATION 11 • n=4 Participants
|
|
Heart Rate from Physical Exam (BPM)
|
80 BPM
STANDARD_DEVIATION 15 • n=5 Participants
|
80 BPM
STANDARD_DEVIATION 13 • n=7 Participants
|
79 BPM
STANDARD_DEVIATION 14 • n=5 Participants
|
79 BPM
STANDARD_DEVIATION 14 • n=4 Participants
|
|
Left Ventricular Ejection Fraction (LVEF)
|
43 %
STANDARD_DEVIATION 9 • n=5 Participants
|
43 %
STANDARD_DEVIATION 10 • n=7 Participants
|
45 %
STANDARD_DEVIATION 9 • n=5 Participants
|
44 %
STANDARD_DEVIATION 9 • n=4 Participants
|
|
Left Ventricular End Diastolic Volume (LVEDV)
|
107 mL
STANDARD_DEVIATION 25 • n=5 Participants
|
107 mL
STANDARD_DEVIATION 31 • n=7 Participants
|
116 mL
STANDARD_DEVIATION 29 • n=5 Participants
|
111 mL
STANDARD_DEVIATION 29 • n=4 Participants
|
|
Left Ventricular End Systolic Volume (LVESV)
|
62 mL
STANDARD_DEVIATION 23 • n=5 Participants
|
62 mL
STANDARD_DEVIATION 22 • n=7 Participants
|
65 mL
STANDARD_DEVIATION 24 • n=5 Participants
|
63 mL
STANDARD_DEVIATION 23 • n=4 Participants
|
|
QRS Width (msec)
|
94 msec
STANDARD_DEVIATION 17 • n=5 Participants
|
97 msec
STANDARD_DEVIATION 17 • n=7 Participants
|
88 msec
STANDARD_DEVIATION 13 • n=5 Participants
|
93 msec
STANDARD_DEVIATION 16 • n=4 Participants
|
|
NYHA
I
|
9 participants
n=5 Participants
|
12 participants
n=7 Participants
|
11 participants
n=5 Participants
|
32 participants
n=4 Participants
|
|
NYHA
II
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
16 participants
n=5 Participants
|
36 participants
n=4 Participants
|
|
NYHA
III
|
15 participants
n=5 Participants
|
12 participants
n=7 Participants
|
9 participants
n=5 Participants
|
36 participants
n=4 Participants
|
|
NYHA
IV
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
NYHA
Subject does not have heart failure
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
NYHA
Missing
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Minnesota Living with Heart Failure Questionnaire (MLWHF)
|
21 units on a scale
STANDARD_DEVIATION 25 • n=5 Participants
|
29 units on a scale
STANDARD_DEVIATION 26 • n=7 Participants
|
32 units on a scale
STANDARD_DEVIATION 29 • n=5 Participants
|
28 units on a scale
STANDARD_DEVIATION 27 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline - 18 Month Follow Up VisitPopulation: The primary analysis cohort for the main objective of this study (Change in Left Ventricular End Diastolic Volume) required a subject to be randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed LVEDV at baseline and 18-month follow-up visit are included.
Left ventricular end diastolic volume (LVEDV) was measured by echocardiogram. Change was measured as Month 18 LVEDV minus baseline LVEDV. Per protocol, change in LVEDV is compared between Pooled Pacing (Single site + Dual Site) and Control.
Outcome measures
| Measure |
Pooled Pacing
n=64 Participants
Subjects successfully implanted with a CRT-D device (either single or dual pacing).
|
Control
n=34 Participants
Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
|
Control
Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
|
|---|---|---|---|
|
Change in Left Ventricular End Diastolic Volume (LVEDV)
|
16.4 mL
Interval 8.9 to 23.9
|
15.8 mL
Interval 5.5 to 26.2
|
—
|
SECONDARY outcome
Timeframe: 18 months post-implantPopulation: Only subjects with attempt implant are included. Therefore, subjects from the Control Arm are not included.
Survival estimates at 18 months post-implant for time to first following events: (a) System Related Adverse Event (b) System Related Complication (c) Procedure Related Adverse Event (d) Procedure Related Complication and (e) System Related or Procedure Related Complication.
Outcome measures
| Measure |
Pooled Pacing
n=38 Participants
Subjects successfully implanted with a CRT-D device (either single or dual pacing).
|
Control
n=38 Participants
Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
|
Control
Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
|
|---|---|---|---|
|
Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events
System-Related Adverse Event
|
0.59 survival probability
Interval 0.41 to 0.73
|
0.68 survival probability
Interval 0.5 to 0.8
|
—
|
|
Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events
System Related Complication
|
0.86 survival probability
Interval 0.7 to 0.94
|
0.87 survival probability
Interval 0.71 to 0.94
|
—
|
|
Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events
Procedure Related Adverse Event
|
0.57 survival probability
Interval 0.4 to 0.71
|
0.66 survival probability
Interval 0.48 to 0.78
|
—
|
|
Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events
Procedure Related Complication
|
0.84 survival probability
Interval 0.68 to 0.92
|
0.84 survival probability
Interval 0.68 to 0.93
|
—
|
|
Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events
System Related or Procedure Related Complication
|
0.79 survival probability
Interval 0.62 to 0.89
|
0.82 survival probability
Interval 0.65 to 0.91
|
—
|
SECONDARY outcome
Timeframe: Baseline - 18 Month Follow Up VisitPopulation: Subject was randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant.
Number of hospitalizations related to cardiovascular events.
Outcome measures
| Measure |
Pooled Pacing
n=38 Participants
Subjects successfully implanted with a CRT-D device (either single or dual pacing).
|
Control
n=37 Participants
Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
|
Control
n=45 Participants
Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
|
|---|---|---|---|
|
Frequency of Hospitalization for Cardiovascular Events
0
|
27 participants
|
22 participants
|
30 participants
|
|
Frequency of Hospitalization for Cardiovascular Events
1
|
6 participants
|
9 participants
|
11 participants
|
|
Frequency of Hospitalization for Cardiovascular Events
2
|
3 participants
|
3 participants
|
0 participants
|
|
Frequency of Hospitalization for Cardiovascular Events
3
|
1 participants
|
1 participants
|
3 participants
|
|
Frequency of Hospitalization for Cardiovascular Events
4
|
0 participants
|
0 participants
|
0 participants
|
|
Frequency of Hospitalization for Cardiovascular Events
5
|
1 participants
|
1 participants
|
0 participants
|
|
Frequency of Hospitalization for Cardiovascular Events
6
|
0 participants
|
0 participants
|
0 participants
|
|
Frequency of Hospitalization for Cardiovascular Events
7
|
0 participants
|
0 participants
|
0 participants
|
|
Frequency of Hospitalization for Cardiovascular Events
8
|
0 participants
|
1 participants
|
0 participants
|
|
Frequency of Hospitalization for Cardiovascular Events
9
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline - 18 Month Follow Up VisitPopulation: Subject was randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed NYHA at baseline and 18-month follow-up visit are included.
The New York Heart Association (NYHA) score classifies patients' heart failure according to the severity of their symptoms. In particular, Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Unable to carry on any physical activity without discomfort. NYHA change from baseline to 18-month visit. If a subject improved by one NYHA class or more (e.g. NYHA IV to NYHA II, or NYHA III to NYHA I, etc) from the baseline visit, the subject was classified as "Improved". Similarly for "Worsened" (e.g. subject does not have heart failure to NYHA I, NYHA I to NYHA II, etc.). If the subjects' NYHA Class is not different than baseline, then the subject was classified as "No Change". Per protocol, change in NYHA is compared between Pooled Pacing (Single site + Dual Site) and Control.
Outcome measures
| Measure |
Pooled Pacing
n=68 Participants
Subjects successfully implanted with a CRT-D device (either single or dual pacing).
|
Control
n=33 Participants
Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
|
Control
Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
|
|---|---|---|---|
|
Change in New York Heart Association (NYHA) Functional Class
Improved
|
26 participants
|
13 participants
|
—
|
|
Change in New York Heart Association (NYHA) Functional Class
No Change
|
25 participants
|
10 participants
|
—
|
|
Change in New York Heart Association (NYHA) Functional Class
Worsened
|
17 participants
|
10 participants
|
—
|
SECONDARY outcome
Timeframe: 1 Month - 18 Month Follow Up VisitPopulation: Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed 6-minute hallwalk distance at baseline and 18-month follow-up visits are included.
Change in 6-minute hallwalk distance from 1-month visit to the 18-month visit. Change is defined as month 18 minus baseline. Per protocol, change in 6-minute walk test distance is compared between Pooled Pacing (Single site + Dual Site) and Control.
Outcome measures
| Measure |
Pooled Pacing
n=63 Participants
Subjects successfully implanted with a CRT-D device (either single or dual pacing).
|
Control
n=28 Participants
Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
|
Control
Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
|
|---|---|---|---|
|
Change in 6-minute Walk Test Distance
|
37.6 meters
Interval 5.8 to 69.3
|
15.6 meters
Interval -32.1 to 63.2
|
—
|
SECONDARY outcome
Timeframe: Baseline - 18 Month Follow Up VisitPopulation: Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed MNLWHF questionnaire score at baseline and 18-month follow-up visits are included.
Change in the Minnesota Living with Heart Failure (MNLWHF) questionnaire from baseline to the 18-month follow-up visit. Change is defined as month 18 minus baseline. Per protocol change in MNLWHF is compared between Pooled Pacing (Dual Site + Single Site) and Control.
Outcome measures
| Measure |
Pooled Pacing
n=69 Participants
Subjects successfully implanted with a CRT-D device (either single or dual pacing).
|
Control
n=32 Participants
Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
|
Control
Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
|
|---|---|---|---|
|
Change in Quality of Life
|
0.4 units on a scale
Interval -5.3 to 6.1
|
-0.1 units on a scale
Interval -8.5 to 8.3
|
—
|
SECONDARY outcome
Timeframe: 18 Months post-randomizationPopulation: Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant.
Mortality rates (%) for the events (a) all-cause death and (b) sudden-cardiac death at 18 months post randomization. Calculated using Kaplan-Meier methods. Per protocol the comparison of mortality rates is between Pooled Pacing (Dual Site + Single Site) and Control.
Outcome measures
| Measure |
Pooled Pacing
n=75 Participants
Subjects successfully implanted with a CRT-D device (either single or dual pacing).
|
Control
n=45 Participants
Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
|
Control
Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
|
|---|---|---|---|
|
Incidence of Sudden Cardiac Death and Total Mortality
All-cause Death
|
4.0 percentage of subjects at risk
Interval 1.3 to 12.0
|
4.7 percentage of subjects at risk
Interval 1.2 to 17.5
|
—
|
|
Incidence of Sudden Cardiac Death and Total Mortality
Sudden-cardiac Death
|
1.4 percentage of subjects at risk
Interval 0.2 to 9.2
|
2.4 percentage of subjects at risk
Interval 0.3 to 16.1
|
—
|
SECONDARY outcome
Timeframe: Baseline - 18 Month Follow Up VisitPopulation: All subjects randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed LVEDV at baseline and 18-month follow-up visit are included.
Linear association between change in LVEDV from baseline to 18-month visit (i.e. ΔLVEDV) and the following clinical characteristics were assessed: age, days from MI to implant, gender, hypertension, hyperlipidemia, diabetes, peak CPK, infarct location, LV electrode in acceptable place, and baseline LVEF. In order to assess these linear associations, linear regression models were fitted for each of these clinical characteristics (separately). In particular, each linear regression model had baseline LVEDV and the clinical characteristic as covariates, and ΔLVEDV was the response variable. Variables resulting in statistical significant (p\<0.05) are reported.
Outcome measures
| Measure |
Pooled Pacing
n=98 Participants
Subjects successfully implanted with a CRT-D device (either single or dual pacing).
|
Control
Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
|
Control
Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
|
|---|---|---|---|
|
Linear Association Between Change in LVEDV and Selected Clinical Characteristics; Including Peak Creatinine Phosphokinase (CPK), Peak Troponin, Lead Location, Time From MI Onset to Implant, and Change in LV Volumes.
Age
|
-0.75 regression coefficient
Standard Error 0.26
|
—
|
—
|
|
Linear Association Between Change in LVEDV and Selected Clinical Characteristics; Including Peak Creatinine Phosphokinase (CPK), Peak Troponin, Lead Location, Time From MI Onset to Implant, and Change in LV Volumes.
Days from MI to Implant*
|
-3.78 regression coefficient
Standard Error 1.64
|
—
|
—
|
|
Linear Association Between Change in LVEDV and Selected Clinical Characteristics; Including Peak Creatinine Phosphokinase (CPK), Peak Troponin, Lead Location, Time From MI Onset to Implant, and Change in LV Volumes.
Baseline LVEF
|
-0.87 regression coefficient
Standard Error 0.35
|
—
|
—
|
Adverse Events
Single Site Pacing
Serious events: 22 serious events
Other events: 20 other events
Deaths: 0 deaths
Dual Site Pacing
Serious events: 24 serious events
Other events: 25 other events
Deaths: 0 deaths
Control
Serious events: 20 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Site Pacing
n=40 participants at risk
Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
|
Dual Site Pacing
n=41 participants at risk
Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
|
Control
n=45 participants at risk
Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
1/40 • Number of events 2
|
0.00%
0/41
|
0.00%
0/45
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/40
|
0.00%
0/41
|
6.7%
3/45 • Number of events 5
|
|
Cardiac disorders
Angina pectoris
|
5.0%
2/40 • Number of events 2
|
2.4%
1/41 • Number of events 2
|
6.7%
3/45 • Number of events 5
|
|
Cardiac disorders
Angina unstable
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/40
|
7.3%
3/41 • Number of events 7
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Atrial flutter
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 2
|
0.00%
0/45
|
|
Cardiac disorders
Atrioventricular block complete
|
5.0%
2/40 • Number of events 2
|
0.00%
0/41
|
0.00%
0/45
|
|
Cardiac disorders
Atrioventricular block second degree
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Cardiac disorders
Cardiac aneurysm
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Cardiac disorders
Cardiac failure congestive
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
8.9%
4/45 • Number of events 6
|
|
Cardiac disorders
Cardiac perforation
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Cardiac disorders
Coronary artery disease
|
5.0%
2/40 • Number of events 2
|
2.4%
1/41 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Decompensated Heart Failure
|
5.0%
2/40 • Number of events 4
|
12.2%
5/41 • Number of events 13
|
13.3%
6/45 • Number of events 6
|
|
Cardiac disorders
Dresslers syndrome
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Ventricular fibrillation
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Cardiac disorders
Ventricular tachycardia
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 2
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Gastrointestinal disorders
Inguinal hernia
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
General disorders
Chest pain
|
5.0%
2/40 • Number of events 2
|
2.4%
1/41 • Number of events 1
|
4.4%
2/45 • Number of events 2
|
|
General disorders
Device infusion issue
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
General disorders
Device stimulation issue
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
General disorders
Implant site haemorrhage
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
General disorders
Lead dislodgement
|
5.0%
2/40 • Number of events 3
|
9.8%
4/41 • Number of events 4
|
0.00%
0/45
|
|
General disorders
Multi-organ failure
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
8.9%
4/45 • Number of events 4
|
|
General disorders
Undersensing
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Infections and infestations
Erysipelas
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Infections and infestations
Implant site infection
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Infections and infestations
Incision site infection
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Infections and infestations
Pneumonia
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
6.7%
3/45 • Number of events 6
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Infections and infestations
Viral myocarditis
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.00%
0/40
|
0.00%
0/41
|
4.4%
2/45 • Number of events 2
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Investigations
International normalised ratio increased
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Metabolism and nutrition disorders
Malnutrition
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Nervous system disorders
Dizziness
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Nervous system disorders
Syncope
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
2/40 • Number of events 2
|
0.00%
0/41
|
0.00%
0/45
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
2/40 • Number of events 3
|
0.00%
0/41
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Vascular disorders
Arterial stenosis
|
2.5%
1/40 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
2.2%
1/45 • Number of events 1
|
|
Vascular disorders
Arterial thrombosis
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Vascular disorders
Hypotension
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Vascular disorders
Orthostatic hypotension
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Vascular disorders
Subclavian steal syndrome
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Vascular disorders
Thrombosis
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
Other adverse events
| Measure |
Single Site Pacing
n=40 participants at risk
Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
|
Dual Site Pacing
n=41 participants at risk
Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
|
Control
n=45 participants at risk
Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Cardiac disorders
Angina pectoris
|
5.0%
2/40 • Number of events 2
|
2.4%
1/41 • Number of events 1
|
4.4%
2/45 • Number of events 2
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Cardiac disorders
Bradycardia
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Cardiac disorders
Cardiac failure congestive
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Cardiac disorders
Decompensated Heart Failure
|
2.5%
1/40 • Number of events 1
|
7.3%
3/41 • Number of events 3
|
8.9%
4/45 • Number of events 5
|
|
Cardiac disorders
Intracardiac thrombus
|
2.5%
1/40 • Number of events 1
|
7.3%
3/41 • Number of events 3
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
5.0%
2/40 • Number of events 2
|
2.4%
1/41 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Sinus bradycardia
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Cardiac disorders
Ventricular fibrillation
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Cardiac disorders
Ventricular tachycardia
|
5.0%
2/40 • Number of events 2
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Endocrine disorders
Hypogonadism
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Eye disorders
Keratitis
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Gastrointestinal disorders
Dental discomfort
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Gastrointestinal disorders
Large intestine polyp
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
General disorders
Adverse drug reaction
|
2.5%
1/40 • Number of events 1
|
7.3%
3/41 • Number of events 3
|
0.00%
0/45
|
|
General disorders
Chest pain
|
5.0%
2/40 • Number of events 2
|
7.3%
3/41 • Number of events 3
|
4.4%
2/45 • Number of events 2
|
|
General disorders
Device alarm issue
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
General disorders
Device capturing issue
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
General disorders
Device electrical impedance issue
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
General disorders
Device infusion issue
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
General disorders
Device malfunction
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
General disorders
Device occlusion
|
0.00%
0/40
|
2.4%
1/41 • Number of events 3
|
0.00%
0/45
|
|
General disorders
Device pacing issue
|
10.0%
4/40 • Number of events 4
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
General disorders
Device stimulation issue
|
20.0%
8/40 • Number of events 13
|
9.8%
4/41 • Number of events 4
|
0.00%
0/45
|
|
General disorders
Fatigue
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Implant site bruising
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
General disorders
Implant site oedema
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
General disorders
Implant site pain
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
General disorders
Implant site scar
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
General disorders
Implant site swelling
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
General disorders
Lead dislodgement
|
5.0%
2/40 • Number of events 2
|
0.00%
0/41
|
0.00%
0/45
|
|
General disorders
Medical device pain
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
4.4%
2/45 • Number of events 2
|
|
General disorders
Oedema peripheral
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
General disorders
Oversensing
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
General disorders
Peripheral swelling
|
5.0%
2/40 • Number of events 2
|
0.00%
0/41
|
0.00%
0/45
|
|
General disorders
Phantom shocks
|
0.00%
0/40
|
4.9%
2/41 • Number of events 2
|
0.00%
0/45
|
|
General disorders
Undersensing
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Infections and infestations
Bronchitis
|
5.0%
2/40 • Number of events 2
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Infections and infestations
Diverticulitis
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Infections and infestations
Echinococciasis
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Infections and infestations
Impetigo
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Infections and infestations
Implant site infection
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Infections and infestations
Influenza
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Injury, poisoning and procedural complications
Cardiac vein dissection
|
0.00%
0/40
|
4.9%
2/41 • Number of events 2
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Cardiac vein perforation
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Contusion
|
5.0%
2/40 • Number of events 2
|
0.00%
0/41
|
4.4%
2/45 • Number of events 2
|
|
Injury, poisoning and procedural complications
Foreign body
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Laceration
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Investigations
Biopsy skin
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Investigations
Blood pressure increased
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Investigations
Blood urine present
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Investigations
Body temperature increased
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Investigations
C-reactive protein increased
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Investigations
Echocardiogram abnormal
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Investigations
Hepatic enzyme increased
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Investigations
International normalised ratio increased
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 2
|
|
Investigations
Liver function test abnormal
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Metabolism and nutrition disorders
Gout
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40 • Number of events 1
|
7.3%
3/41 • Number of events 3
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/40
|
0.00%
0/41
|
4.4%
2/45 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
4.4%
2/45 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal adenoma
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Nervous system disorders
Dizziness
|
5.0%
2/40 • Number of events 2
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Headache
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Nervous system disorders
Sciatica
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Syncope
|
7.5%
3/40 • Number of events 3
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Psychiatric disorders
Acute stress disorder
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Psychiatric disorders
Stress
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/40
|
9.8%
4/41 • Number of events 4
|
6.7%
3/45 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
2.5%
1/40 • Number of events 2
|
0.00%
0/41
|
0.00%
0/45
|
|
Skin and subcutaneous tissue disorders
Photodermatosis
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Vascular disorders
Hypertension
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
0.00%
0/45
|
|
Vascular disorders
Hypotension
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
6.7%
3/45 • Number of events 3
|
|
Vascular disorders
Orthostatic hypotension
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/40
|
0.00%
0/41
|
2.2%
1/45 • Number of events 1
|
|
Vascular disorders
Venous stenosis
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
0.00%
0/45
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60