Trial Outcomes & Findings for A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX) (NCT NCT01156571)

NCT ID: NCT01156571

Last Updated: 2014-02-04

Results Overview

Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat \[mITT\] population)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

11145 participants

Primary outcome timeframe

48 hours after randomization

Results posted on

2014-02-04

Participant Flow

Date first patient enrolled: 30 Sep 2010 Date last patient completed: 14 Nov 2012 This trial enrolled the full spectrum of patients who required PCI (SA, NSTE-ACS, STEMI). Randomization occurred after confirmation of need for PCI (after diagnostic angiogram in all cases, except for STEMI patients). Patients were followed through 30-days.

Due to the nature of the disease, STEMI patients were permitted to be randomized upon ECG confirmation and prior to confirmation of need for PCI (prior to diagnostic angiography). Therefore in some cases, STEMI patients did not require PCI and therefore did not receive all study drug.

Participant milestones

Participant milestones
Measure	Cangrelor Treatment Arm Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours. Immediately after discontinuation of infusion, an oral transition dose of clopidogrel 600 mg was administered. Patients also received oral placebo capsules, administered as soon as possible following randomization at investigator discretion. These capsules were designed to match the clopidogrel 600 mg or 300 mg loading dose.	Clopidogrel Treatment Arm Oral clopidogrel was administered as soon as possible following randomization at investigator discretion at a loading dose of either 600 mg or 300 mg as specified by the investigator. Patients in the clopidogrel treatment arm received IV placebo for 2 hours or end of the PCI procedure, whichever was longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours. At the end of IV placebo infusion, patients were given oral placebo capsules matching the oral clopidogrel transition dose.
Overall Study STARTED	5581	5564
Overall Study COMPLETED	5564	5545
Overall Study NOT COMPLETED	17	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cangrelor Treatment Arm n=5581 Participants Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours. Immediately after discontinuation of infusion, an oral transition dose of clopidogrel 600 mg was administered. Patients also received oral placebo capsules, administered as soon as possible following randomization at investigator discretion. These capsules were designed to match the clopidogrel 600 mg or 300 mg loading dose.	Clopidogrel Treatment Arm n=5564 Participants Oral clopidogrel was administered as soon as possible following randomization at investigator discretion at a loading dose of either 600 mg or 300 mg as specified by the investigator. Patients in the clopidogrel treatment arm received IV placebo for 2 hours or end of the PCI procedure, whichever was longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours. At the end of IV placebo infusion, patients were given oral placebo capsules matching the oral clopidogrel transition dose.	Total n=11145 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2892 Participants n=5 Participants	2902 Participants n=7 Participants	5794 Participants n=5 Participants
Age, Categorical >=65 years	2689 Participants n=5 Participants	2662 Participants n=7 Participants	5351 Participants n=5 Participants
Age, Continuous	64.0 years STANDARD_DEVIATION 11.0 • n=5 Participants	63.8 years STANDARD_DEVIATION 11.0 • n=7 Participants	63.9 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	1599 Participants n=5 Participants	1522 Participants n=7 Participants	3121 Participants n=5 Participants
Sex: Female, Male Male	3982 Participants n=5 Participants	4042 Participants n=7 Participants	8024 Participants n=5 Participants
Region of Enrollment United States	2099 participants n=5 Participants	2089 participants n=7 Participants	4188 participants n=5 Participants
Region of Enrollment Austria	302 participants n=5 Participants	300 participants n=7 Participants	602 participants n=5 Participants
Region of Enrollment Brazil	78 participants n=5 Participants	80 participants n=7 Participants	158 participants n=5 Participants
Region of Enrollment Bulgaria	169 participants n=5 Participants	167 participants n=7 Participants	336 participants n=5 Participants
Region of Enrollment Czech Republic	814 participants n=5 Participants	816 participants n=7 Participants	1630 participants n=5 Participants
Region of Enrollment Georgia	744 participants n=5 Participants	741 participants n=7 Participants	1485 participants n=5 Participants
Region of Enrollment Germany	243 participants n=5 Participants	251 participants n=7 Participants	494 participants n=5 Participants
Region of Enrollment Italy	311 participants n=5 Participants	310 participants n=7 Participants	621 participants n=5 Participants
Region of Enrollment New Zealand	22 participants n=5 Participants	23 participants n=7 Participants	45 participants n=5 Participants
Region of Enrollment Poland	352 participants n=5 Participants	350 participants n=7 Participants	702 participants n=5 Participants
Region of Enrollment Russian Federation	296 participants n=5 Participants	286 participants n=7 Participants	582 participants n=5 Participants
Region of Enrollment Thailand	151 participants n=5 Participants	151 participants n=7 Participants	302 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours after randomization

Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat \[mITT\] population)

Outcome measures

Outcome measures
Measure	Cangrelor Treatment Arm n=5470 Participants	Clopidogrel Treatment Arm n=5469 Participants
The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)	257 participants	322 participants

SECONDARY outcome

Timeframe: 48 hours after randomization

CEC-adjudicated results (mITT population)

Outcome measures

Outcome measures
Measure	Cangrelor Treatment Arm n=5470 Participants	Clopidogrel Treatment Arm n=5469 Participants
Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR) Stent Thrombosis	46 participants	74 participants
Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR) Death	18 participants	18 participants
Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR) MI (myocardial infarction)	207 participants	255 participants
Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR) IDR (ischemia-driven revascularization)	28 participants	38 participants

SECONDARY outcome

Timeframe: 48 hours after randomization

GUSTO = Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries trial

Outcome measures

Outcome measures
Measure	Cangrelor Treatment Arm n=5529 Participants	Clopidogrel Treatment Arm n=5527 Participants
Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild GUSTO severe/life threatening	9 participants	6 participants
Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild GUSTO moderate	22 participants	13 participants
Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild GUSTO severe or moderate	31 participants	19 participants
Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild TIMI major	5 participants	5 participants
Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild TIMI minor	9 participants	3 participants
Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild TIMI major or minor	14 participants	8 participants
Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild Any blood transfusion	25 participants	16 participants

Adverse Events

Cangrelor Treatment Arm

Serious events: 122 serious events

Other events: 0 other events

Deaths: 0 deaths

Clopidogrel Treatment Arm

Serious events: 105 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Meredith Todd - Sr. Director Program Management

The Medicines Company

Phone: +1.973.290.6088

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In general, PI communications regarding trial results are prohibited until after the communication and publication of the multi-center results by Sponsor, but no more than 12 months after conclusion of the trial at all sites. PI must submit results communications to sponsor for review at least 45 days prior to submission for publication and Sponsor may embargo such communications for a period that is less than or equal to 135 days solely to seek appropriate patent protection.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Cangrelor Treatment Arm n=5529 participants at risk	Clopidogrel Treatment Arm n=5527 participants at risk
Blood and lymphatic system disorders Anaemia	0.02% 1/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.00% 0/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Blood and lymphatic system disorders Hypersplenism	0.00% 0/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.02% 1/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.02% 1/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders acute coronary syndrome	0.02% 1/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.00% 0/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders acute myocardial infarction	0.04% 2/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.05% 3/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders angina pectoris	0.02% 1/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.02% 1/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders angina unstable	0.04% 2/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.02% 1/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders Arteriospasm coronary	0.02% 1/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.00% 0/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders atrial fibrillation	0.04% 2/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.04% 2/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders atrioventricular block complete	0.05% 3/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.05% 3/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders bradycardia	0.02% 1/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.02% 1/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders cardiac arrest	0.09% 5/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.14% 8/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders cardiac failure	0.02% 1/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.05% 3/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders cardiac failure acute	0.02% 1/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.00% 0/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders cardiac failure congestive	0.05% 3/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.05% 3/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders cardiac tamponade	0.02% 1/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.00% 0/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders cardio-respiratory arrest	0.05% 3/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.02% 1/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders cardiogenic shock	0.22% 12/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.11% 6/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders coronary artery disease	0.00% 0/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.02% 1/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders coronary artery dissection	0.16% 9/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.11% 6/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders coronary artery occlusion	0.00% 0/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.07% 4/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders coronary artery performation	0.05% 3/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.05% 3/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders Interventricluar septum rupture	0.04% 2/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.00% 0/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders myocardial infarction	0.04% 2/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.02% 1/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders mycardial rupture	0.00% 0/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.05% 3/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders nodal arrhythmia	0.02% 1/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.02% 1/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders percarditis	0.00% 0/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.02% 1/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders sick sinus syndrome	0.02% 1/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.02% 1/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders sinus arrest	0.02% 1/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.00% 0/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders ventricular rupture	0.02% 1/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.00% 0/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders ventricular asystole	0.00% 0/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.02% 1/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders ventricular fibrillation	0.11% 6/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.13% 7/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Cardiac disorders ventricluar tachycardia	0.09% 5/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.05% 3/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Gastrointestinal disorders gastroesophageal reflux disease	0.00% 0/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.02% 1/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
General disorders chest discomfort	0.02% 1/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.00% 0/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
General disorders chest pain	0.09% 5/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.04% 2/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
General disorders non-cardiac chest pain	0.04% 2/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.00% 0/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
General disorders pyrexia	0.00% 0/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.02% 1/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
General disorders thrombosis in device	0.05% 3/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.05% 3/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Hepatobiliary disorders hepatic cirrhosis	0.00% 0/5529 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.	0.02% 1/5527 • AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.