Trial Outcomes & Findings for A Study of Abciximab and Reteplase When Administered Prior to Catherization After a Myocardial Infarction (Finesse) (NCT NCT00046228)
NCT ID: NCT00046228
Last Updated: 2014-07-31
Results Overview
Occurs within 90 days and is composite of all-cause mortality or complications of myocardial infarction (MI) (rehospitalization or emergency department visit for congestive heart failure (CHF), cardiogenic shock, or resuscitated ventricular fibrillation occurring \> 48 hours after randomization).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2461 participants
Primary outcome timeframe
90 days
Results posted on
2014-07-31
Participant Flow
The study was conducted in 20 countries. The FINESSE (Facilitated INtervention with Enhanced Reperfusion Speed to Stop Events) study began enrollment in August 2002. It was planned that approximately 3,000 subjects would be enrolled. Because of enrollment difficulty, subject enrollment was stopped on 30 Dec 2006.
A total of 2,461 subjects were enrolled in the study according to the sponsor's clinical trial management system. Out of 2461 subjects, 2,452 subjects were randomly assigned to the 3 treatment groups.
Participant milestones
| Measure |
Primary PCI Group
Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
|
Abciximab Facilitated PCI Group
Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
|
Reteplase/Abciximab Facilitated PCI Group
Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects \< 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
|
|---|---|---|---|
|
90 Days
STARTED
|
806
|
818
|
828
|
|
90 Days
COMPLETED
|
793
|
810
|
813
|
|
90 Days
NOT COMPLETED
|
13
|
8
|
15
|
|
1 Year
STARTED
|
806
|
818
|
828
|
|
1 Year
COMPLETED
|
787
|
804
|
816
|
|
1 Year
NOT COMPLETED
|
19
|
14
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Abciximab and Reteplase When Administered Prior to Catherization After a Myocardial Infarction (Finesse)
Baseline characteristics by cohort
| Measure |
Primary PCI Group
n=806 Participants
Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
|
Abciximab Facilitated PCI Group
n=818 Participants
Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
|
Reteplase/Abciximab Facilitated PCI Group
n=828 Participants
Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects \< 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
|
Total
n=2452 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 11.4 • n=93 Participants
|
61.9 years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
62.6 years
STANDARD_DEVIATION 11.4 • n=27 Participants
|
62.4 years
STANDARD_DEVIATION 11.5 • n=483 Participants
|
|
Sex: Female, Male
Female
|
207 Participants
n=93 Participants
|
216 Participants
n=4 Participants
|
219 Participants
n=27 Participants
|
642 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
599 Participants
n=93 Participants
|
602 Participants
n=4 Participants
|
609 Participants
n=27 Participants
|
1810 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Population is the intent-to-treat subjects. The intent-to-treat population is defined as all subjects randomly assigned to a treatment group and classified according to the randomization assignment.
Occurs within 90 days and is composite of all-cause mortality or complications of myocardial infarction (MI) (rehospitalization or emergency department visit for congestive heart failure (CHF), cardiogenic shock, or resuscitated ventricular fibrillation occurring \> 48 hours after randomization).
Outcome measures
| Measure |
Primary PCI Group
n=806 Participants
Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
|
Abciximab Facilitated PCI Group
n=818 Participants
Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
|
Reteplase/Abciximab Facilitated PCI Group
n=828 Participants
Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects \< 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
|
|---|---|---|---|
|
The Composite of All-Cause Mortality or Complications of MI at 90 Days.
|
86 participants
|
86 participants
|
81 participants
|
SECONDARY outcome
Timeframe: 90 DaysPopulation: Population is the intent-to-treat subjects. The intent-to-treat population is defined as all subjects that have been randomly assigned to a treatment group and classified according to the randomization assignment.
The complications of myocardial infarction (MI) is defined as any event of rehospitalization or emergency department visit for CHF, cardiogenic shock, or resuscitated ventricular fibrillation occurring \> 48 hours after randomization.
Outcome measures
| Measure |
Primary PCI Group
n=806 Participants
Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
|
Abciximab Facilitated PCI Group
n=818 Participants
Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
|
Reteplase/Abciximab Facilitated PCI Group
n=828 Participants
Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects \< 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
|
|---|---|---|---|
|
Complications of MI as Defined in the Primary Outcome Measure Through 90 Days
|
72 participants
|
61 participants
|
61 participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment.
All cause mortality occurred through 90 days from randomization.
Outcome measures
| Measure |
Primary PCI Group
n=806 Participants
Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
|
Abciximab Facilitated PCI Group
n=818 Participants
Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
|
Reteplase/Abciximab Facilitated PCI Group
n=828 Participants
Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects \< 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
|
|---|---|---|---|
|
All-Cause Mortality Through 90 Days
|
36 participants
|
45 participants
|
43 participants
|
SECONDARY outcome
Timeframe: 60 to 90 minutesPopulation: Population is the intent-to-treat subjects who were selected for evaluation by electrocardiogram (ECG) core laboratory.Subjects, who were not evaluable for a 60-90 minute ECG, were considered not having a ST segment resolution.
Outcome measures
| Measure |
Primary PCI Group
n=405 Participants
Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
|
Abciximab Facilitated PCI Group
n=432 Participants
Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
|
Reteplase/Abciximab Facilitated PCI Group
n=424 Participants
Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects \< 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
|
|---|---|---|---|
|
Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization
|
75 participants
|
85 participants
|
108 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment.
All-cause mortality through 1 year from randomization.
Outcome measures
| Measure |
Primary PCI Group
n=806 Participants
Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
|
Abciximab Facilitated PCI Group
n=818 Participants
Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
|
Reteplase/Abciximab Facilitated PCI Group
n=828 Participants
Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects \< 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
|
|---|---|---|---|
|
All-Cause Mortality Through 1 Year
|
56 participants
|
60 participants
|
52 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Discharge/Day 7Population: The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.
All cases of cerebrovascular event were confirmed by a CEC (Clinical Endpoints Committee).
Outcome measures
| Measure |
Primary PCI Group
n=795 Participants
Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
|
Abciximab Facilitated PCI Group
n=805 Participants
Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
|
Reteplase/Abciximab Facilitated PCI Group
n=814 Participants
Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects \< 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
|
|---|---|---|---|
|
Subjects With Intracranial Hemorrhage (Including Hemorrhagic Transformation) Through Discharge/Day 7
|
1 participants
|
0 participants
|
5 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Discharge/Day 7Population: The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.
Subjects with nonintracranial TIMI bleeding (either major or minor) through discharge/day 7, originating from vascular instrumentation sites, non-instrument related bleeding, as well as overall, were examined.
Outcome measures
| Measure |
Primary PCI Group
n=795 Participants
Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
|
Abciximab Facilitated PCI Group
n=805 Participants
Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
|
Reteplase/Abciximab Facilitated PCI Group
n=814 Participants
Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects \< 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
|
|---|---|---|---|
|
Subjects With Non Intracranial Thrombolysis In Myocardial Infarction (TIMI) Bleeding Events Through Discharge/Day 7
|
55 participant
|
81 participant
|
118 participant
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Discharge/Day 7Population: The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.
Severe thrombocytopenia is defined as platelet count \< 50,000 cells/μL.
Outcome measures
| Measure |
Primary PCI Group
n=795 Participants
Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
|
Abciximab Facilitated PCI Group
n=805 Participants
Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
|
Reteplase/Abciximab Facilitated PCI Group
n=814 Participants
Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects \< 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
|
|---|---|---|---|
|
Subjects With Severe Thrombocytopenia Through Discharge/Day 7
|
11 participants
|
16 participants
|
16 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Discharge/Day 7Population: The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.
Outcome measures
| Measure |
Primary PCI Group
n=795 Participants
Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
|
Abciximab Facilitated PCI Group
n=805 Participants
Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
|
Reteplase/Abciximab Facilitated PCI Group
n=814 Participants
Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects \< 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
|
|---|---|---|---|
|
Subjects With Any Investigator Reported Bleeding Events Through Discharge/Day 7
|
139 participants
|
178 participants
|
271 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Discharge/Day 7Population: Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment.
Number of subjects with one or more of the following: 2nd or 3rd Degree AVB, Asystole, Sustained V Tach, A Fib/Flutter, EMD/Pulseless Electrical Activity, Heart Failure, Tamponade, Myocardial Rupture, Papillary Muscle Rupture, Ventricular Septal Defect, Pulmonary Embolism, Systemic Arterial Embolism and/or Pericarditis/Pericardial Effusion.
Outcome measures
| Measure |
Primary PCI Group
n=806 Participants
Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
|
Abciximab Facilitated PCI Group
n=818 Participants
Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
|
Reteplase/Abciximab Facilitated PCI Group
n=828 Participants
Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects \< 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
|
|---|---|---|---|
|
Subjects With Pre-Specified Complications of Index Myocardial Infarction Through Discharge/Day 7
|
128 participants
|
122 participants
|
120 participants
|
Adverse Events
Primary PCI Group
Serious events: 159 serious events
Other events: 0 other events
Deaths: 0 deaths
Abciximab Facilitated PCI Group
Serious events: 182 serious events
Other events: 0 other events
Deaths: 0 deaths
Reteplase/Abciximab Facilitated PCI Group
Serious events: 175 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Primary PCI Group
n=795 participants at risk
Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
|
Abciximab Facilitated PCI Group
n=805 participants at risk
Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
|
Reteplase/Abciximab Facilitated PCI Group
n=814 participants at risk
Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects \< 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
|
|---|---|---|---|
|
Cardiac disorders
Coronary stenosis
|
2.9%
23/795
|
4.7%
38/805
|
3.3%
27/814
|
|
Cardiac disorders
Shock cardiogenic
|
0.50%
4/795
|
1.1%
9/805
|
1.6%
13/814
|
|
Cardiac disorders
Unstable angina
|
0.50%
4/795
|
0.25%
2/805
|
0.74%
6/814
|
|
Cardiac disorders
Myocardial infarction
|
0.75%
6/795
|
1.2%
10/805
|
0.61%
5/814
|
|
Cardiac disorders
Angina pectoris
|
0.25%
2/795
|
0.37%
3/805
|
0.49%
4/814
|
|
Cardiac disorders
Congestive heart failure
|
0.00%
0/795
|
0.37%
3/805
|
0.49%
4/814
|
|
Cardiac disorders
Myocardial ischemia
|
0.13%
1/795
|
0.12%
1/805
|
0.49%
4/814
|
|
Cardiac disorders
Cardiac failure
|
0.38%
3/795
|
0.62%
5/805
|
0.37%
3/814
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/795
|
0.37%
3/805
|
0.25%
2/814
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/795
|
0.00%
0/805
|
0.25%
2/814
|
|
Cardiac disorders
Chronic congestive heart failure
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Cardiac disorders
Heart disorder
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Cardiac disorders
Myocardial rupture
|
0.25%
2/795
|
0.25%
2/805
|
0.12%
1/814
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/795
|
0.12%
1/805
|
0.12%
1/814
|
|
Cardiac disorders
Spiral coronary artery dissection
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Cardiac disorders
Stable angina pectoris
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Cardiac disorders
Tricuspid insufficiency
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Cardiac disorders
Anginal pain
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Cardiac disorders
Aortic stenosis
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/795
|
0.25%
2/805
|
0.00%
0/814
|
|
Cardiac disorders
Coronary artery perforation
|
0.00%
0/795
|
0.25%
2/805
|
0.00%
0/814
|
|
Cardiac disorders
Coronary in-stent restenosis
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Cardiac disorders
Coronary restenosis
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Cardiac disorders
Endocarditis
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Cardiac disorders
Left ventricular ejection fraction decreased
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Cardiac disorders
Mitral insufficiency
|
0.25%
2/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Cardiac disorders
Mitral regurgitation
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/795
|
0.25%
2/805
|
0.00%
0/814
|
|
Cardiac disorders
Ventricular septal defect
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Cardiac disorders
Fibrillation ventricular
|
3.3%
26/795
|
2.6%
21/805
|
2.0%
16/814
|
|
Cardiac disorders
Cardiac arrest
|
0.63%
5/795
|
0.25%
2/805
|
0.37%
3/814
|
|
Cardiac disorders
Tachycardia ventricular
|
0.25%
2/795
|
0.62%
5/805
|
0.25%
2/814
|
|
Cardiac disorders
AV block complete
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Cardiac disorders
AV block third degree
|
0.13%
1/795
|
0.12%
1/805
|
0.12%
1/814
|
|
Cardiac disorders
Junctional bradycardia
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Cardiac disorders
Nonsustained ventricular tachycardia
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/795
|
0.12%
1/805
|
0.12%
1/814
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Cardiac disorders
Arrhythmia ventricular
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Cardiac disorders
Asystolia
|
0.13%
1/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Cardiac disorders
Atrial fibrillation
|
0.50%
4/795
|
0.25%
2/805
|
0.00%
0/814
|
|
Cardiac disorders
Atrial fibrillation paroxysmal
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Cardiac disorders
Atrial flutter
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Cardiac disorders
AV block second degree
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Cardiac disorders
Cardiac arrhythmia nos
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Cardiac disorders
Cardiac rhythm disturbance
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Cardiac disorders
Cardiopulmonary arrest
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Cardiac disorders
Electromechanical dissociation
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Cardiac disorders
Intraventricular conduction defect
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Cardiac disorders
Tachycardia atrial paroxysmal
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Cardiac disorders
Ventricular bigeminy
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Cardiac disorders
Ventricular febrillation paroxysm
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.88%
7/795
|
0.99%
8/805
|
0.86%
7/814
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumonia
|
0.25%
2/795
|
0.25%
2/805
|
0.37%
3/814
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.38%
3/795
|
0.50%
4/805
|
0.37%
3/814
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/795
|
0.25%
2/805
|
0.25%
2/814
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.13%
1/795
|
0.37%
3/805
|
0.25%
2/814
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Respiratory, thoracic and mediastinal disorders
Breathing difficult
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.13%
1/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/795
|
0.12%
1/805
|
0.12%
1/814
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/795
|
0.12%
1/805
|
0.12%
1/814
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritis
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Respiratory, thoracic and mediastinal disorders
Repiratory tract infection
|
0.13%
1/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract lesion
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Respiratory, thoracic and mediastinal disorders
Breathlessness
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.25%
2/795
|
0.25%
2/805
|
0.00%
0/814
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract infection
|
0.13%
1/795
|
0.25%
2/805
|
0.00%
0/814
|
|
Respiratory, thoracic and mediastinal disorders
Pleural exudate
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia interstitial
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Cardiac disorders
Atherosclerosis
|
1.8%
14/795
|
0.50%
4/805
|
1.7%
14/814
|
|
Cardiac disorders
Hypotension
|
0.13%
1/795
|
0.00%
0/805
|
0.25%
2/814
|
|
Cardiac disorders
Syncope
|
0.13%
1/795
|
0.25%
2/805
|
0.25%
2/814
|
|
Cardiac disorders
Blood pressure high
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Cardiac disorders
Hypertension
|
0.25%
2/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Cardiac disorders
Transient hypotension
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Cardiac disorders
Collapse
|
0.13%
1/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Cardiac disorders
Hypertension arterial
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Cardiac disorders
Hypovolemic shock
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Cardiac disorders
Septic shock
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Cardiac disorders
Shock
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
General disorders
Chest pain
|
1.3%
10/795
|
2.4%
19/805
|
1.5%
12/814
|
|
General disorders
Death
|
0.00%
0/795
|
0.25%
2/805
|
0.12%
1/814
|
|
General disorders
Non-anginal pain
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
General disorders
Non-ischemic chest pain
|
0.00%
0/795
|
0.12%
1/805
|
0.12%
1/814
|
|
General disorders
Allergic reaction
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
General disorders
Allergic reaction to diagnostic agent
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
General disorders
Incarcerated abdonimal hernia
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
General disorders
Inguinal hernia
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
General disorders
Interstitial fluid increased
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
General disorders
Intolerance induced
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
General disorders
Malaise
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
General disorders
Musculoskeletal pain
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
General disorders
Nontoxic drug overdose
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
General disorders
Pain
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Gastrointestinal disorders
Diarrhea
|
0.13%
1/795
|
0.12%
1/805
|
0.12%
1/814
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/795
|
0.12%
1/805
|
0.12%
1/814
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Gastrointestinal disorders
Esophageal reflux
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Gastrointestinal disorders
Intestinal Polyp
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Gastrointestinal disorders
Nontropical sprue
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.13%
1/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Gastrointestinal disorders
Preploric ulcer
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Gastrointestinal disorders
Digestion impaired
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Gastrointestinal disorders
Epigastric pain
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.13%
1/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Gastrointestinal disorders
Stomach upset
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Renal and urinary disorders
Acute renal failure
|
0.25%
2/795
|
0.12%
1/805
|
0.49%
4/814
|
|
Renal and urinary disorders
Urinary tract infection
|
0.13%
1/795
|
0.25%
2/805
|
0.25%
2/814
|
|
Renal and urinary disorders
Chronic renal failure
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Renal and urinary disorders
Creatinine increased
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Renal and urinary disorders
Renal function decreased
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Renal and urinary disorders
Urethral disorder nos
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Renal and urinary disorders
Urinary retention
|
0.13%
1/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Renal and urinary disorders
Acute renal insufficiency
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Renal and urinary disorders
Bladder stricture
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Renal and urinary disorders
Pyelonephritis
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Renal and urinary disorders
Renal failure
|
0.38%
3/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Renal and urinary disorders
Renal insufficiency
|
0.00%
0/795
|
0.25%
2/805
|
0.00%
0/814
|
|
Vascular disorders
Hemorrhagic stroke
|
0.00%
0/795
|
0.00%
0/805
|
0.25%
2/814
|
|
Vascular disorders
Gastric hemorrhage
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Vascular disorders
GI hemorrhage
|
0.25%
2/795
|
0.12%
1/805
|
0.12%
1/814
|
|
Vascular disorders
GI hemorrhage - upper
|
0.13%
1/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Vascular disorders
Hematoma
|
0.13%
1/795
|
0.12%
1/805
|
0.12%
1/814
|
|
Vascular disorders
Hemoptysis
|
0.13%
1/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Vascular disorders
Hemorrhage nos
|
0.00%
0/795
|
0.12%
1/805
|
0.12%
1/814
|
|
Vascular disorders
Hematemesis
|
0.25%
2/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Vascular disorders
Hemorrhage rectum
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Vascular disorders
Pulmonary hemorrhage
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Vascular disorders
Puncture site hematoma
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Vascular disorders
Retroperitoneal hemorrhage (type unknown)
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Vascular disorders
Vomiting blood
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Vascular disorders
Stroke
|
0.38%
3/795
|
0.25%
2/805
|
0.37%
3/814
|
|
Vascular disorders
Claudication intermittent
|
0.00%
0/795
|
0.00%
0/805
|
0.25%
2/814
|
|
Vascular disorders
Arterial stenosis
|
0.13%
1/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Vascular disorders
Pseudoaneurysm
|
0.00%
0/795
|
0.12%
1/805
|
0.12%
1/814
|
|
Vascular disorders
Vasculitis
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Vascular disorders
Cerebral infarction
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Vascular disorders
Cerebrovascular accident
|
0.13%
1/795
|
0.37%
3/805
|
0.00%
0/814
|
|
Vascular disorders
Claudication
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Vascular disorders
Extracardiact arterial aneurysm
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Vascular disorders
Peripheral ischemia
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Vascular disorders
Phlebitis
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Vascular disorders
Transient ischemic attack
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pulmonary cancer
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pulmonary carcinoma
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal carcinoma
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma nos
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast carcinoma
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cyst malignant
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Vascular disorders
Thrombosis coronary artery
|
0.13%
1/795
|
0.00%
0/805
|
0.25%
2/814
|
|
Vascular disorders
Thrombosis cardiac chamber
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Vascular disorders
Atheroembolism limb
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Vascular disorders
Embolism pulmonary
|
0.25%
2/795
|
0.37%
3/805
|
0.00%
0/814
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Vascular disorders
Thrombosis venous deep
|
0.13%
1/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Vascular disorders
Thrombosis
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Vascular disorders
Venous thrombosis leg
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Musculoskeletal and connective tissue disorders
Aseptic necrosis bone
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Musculoskeletal and connective tissue disorders
Bone fracture
|
0.00%
0/795
|
0.12%
1/805
|
0.12%
1/814
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.13%
1/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Musculoskeletal and connective tissue disorders
Skeletal pain
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
0.13%
1/795
|
0.00%
0/805
|
0.25%
2/814
|
|
Metabolism and nutrition disorders
Adult onset diabetes mellitus
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Metabolism and nutrition disorders
Dehydration
|
0.13%
1/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.25%
2/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/795
|
0.25%
2/805
|
0.00%
0/814
|
|
Infections and infestations
Cellulitis
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Infections and infestations
Fever
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Infections and infestations
Infection bacterial
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Infections and infestations
Influenza
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Infections and infestations
Urosepsis
|
0.00%
0/795
|
0.25%
2/805
|
0.00%
0/814
|
|
Infections and infestations
Wound healing impaired
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Infections and infestations
Wound infection
|
0.25%
2/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Nervous system disorders
Epilepsy grand mal
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Nervous system disorders
Pre-syncope
|
0.00%
0/795
|
0.12%
1/805
|
0.12%
1/814
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Nervous system disorders
Coma
|
0.00%
0/795
|
0.25%
2/805
|
0.00%
0/814
|
|
Nervous system disorders
Dizziness
|
0.13%
1/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/795
|
0.12%
1/805
|
0.12%
1/814
|
|
Hepatobiliary disorders
Gall bladder distention
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Hepatobiliary disorders
Hepatobiliary dysfunction
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Hepatobiliary disorders
Jaundice
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.13%
1/795
|
0.37%
3/805
|
0.12%
1/814
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Blood and lymphatic system disorders
Anemia
|
0.13%
1/795
|
0.37%
3/805
|
0.00%
0/814
|
|
Blood and lymphatic system disorders
Anemia microcytic
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Skin and subcutaneous tissue disorders
Eruption
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Psychiatric disorders
Anxiety
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Psychiatric disorders
Delirium tremens
|
0.13%
1/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Cardiac disorders
Coronary artery dissection
|
0.00%
0/795
|
0.12%
1/805
|
0.12%
1/814
|
|
Cardiac disorders
Ventricular aneurysm
|
0.00%
0/795
|
0.00%
0/805
|
0.12%
1/814
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/795
|
0.25%
2/805
|
0.00%
0/814
|
|
Respiratory, thoracic and mediastinal disorders
Breath shortness
|
0.13%
1/795
|
0.00%
0/805
|
0.25%
2/814
|
|
Vascular disorders
Left ventricular thrombus
|
0.25%
2/795
|
0.25%
2/805
|
0.25%
2/814
|
|
Vascular disorders
Phlebothrombosis
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
|
Infections and infestations
Sepsis
|
0.13%
1/795
|
0.25%
2/805
|
0.12%
1/814
|
|
Blood and lymphatic system disorders
Anemia iron deficiency
|
0.00%
0/795
|
0.12%
1/805
|
0.00%
0/814
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal carcinoma
|
0.13%
1/795
|
0.00%
0/805
|
0.00%
0/814
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60