Safety Study of Apixaban in Recent Acute Coronary Syndrome | NCT00313300 | Trialant
NCT00313300
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Dec 30, 2015Estimated
Enrollment
1,741Actual
Phase
Phase 2
Conditions
Acute Coronary Syndrome (ACS)
Interventions
Apixaban
Apixaban
Placebo
Apixaban
Countries
United States
Austria
Belgium
Canada
Denmark
France
Germany
Israel
Italy
Poland
Russia
Spain
Sweden
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00313300
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CV185-023
Secondary IDs
Not provided
Brief Title
Safety Study of Apixaban in Recent Acute Coronary Syndrome
Official Title
A Phase 2, Placebo-Controlled, Randomized, Double Blind, Parallel Arm, Dose Ranging Study to Evaluate Safety and Efficacy of Apixaban in Patients With a Recent Acute Coronary Syndrome.
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Nov 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2006
Primary Completion Date
May 2008Actual
Completion Date
May 2008Actual
First Submitted Date
Apr 10, 2006
First Submission Date that Met QC Criteria
Apr 11, 2006
First Posted Date
Apr 12, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 11, 2015
Results First Submitted that Met QC Criteria
Sep 11, 2015
Results First Posted Date
Oct 15, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 25, 2015
Last Update Posted Date
Dec 30, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this clinical research study is to determine whether apixaban will be safe in people who have recently had unstable angina or a heart attack.
Detailed Description
Not provided
Conditions Module
Conditions
Acute Coronary Syndrome (ACS)
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,741Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
A1
Active Comparator
Drug: Apixaban
A2
Experimental
Drug: Apixaban
A3
Placebo Comparator
Drug: Placebo
A4
Experimental
Drug: Apixaban
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Apixaban
Drug
Tablets, Oral, 2.5 mg, twice daily, 26 weeks
A1
Apixaban
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses
Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The primary outcome is based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B. The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups (10mg BID, 20mg QD) and the resulting lower duration of exposure for these groups.
From first dose of study drug (Day 1) to last dose plus 2 days, up to Year 2 of the Study
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With a Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants
Events were adjudicated by the Clinical Events Committee (CEC). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B.
APPRAISE Steering Committee and Investigators; Alexander JH, Becker RC, Bhatt DL, Cools F, Crea F, Dellborg M, Fox KA, Goodman SG, Harrington RA, Huber K, Husted S, Lewis BS, Lopez-Sendon J, Mohan P, Montalescot G, Ruda M, Ruzyllo W, Verheugt F, Wallentin L. Apixaban, an oral, direct, selective factor Xa inhibitor, in combination with antiplatelet therapy after acute coronary syndrome: results of the Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) trial. Circulation. 2009 Jun 9;119(22):2877-85. doi: 10.1161/CIRCULATIONAHA.108.832139. Epub 2009 May 26.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
1741 enrolled; 1715 randomized. Non-randomization reasons: 6 withdrew consent, 1 death, 1 poor/non-compliance, 18 no longer met study criteria. Phase A: placebo and 2 low doses of apixaban; Phase B: placebo, 2 low doses and 2 high doses of apixaban. High dose arms terminated, Phase B continued to enroll participants into placebo and low dose arms.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Study was conducted in 2 Phases (A and B). A tablet of Placebo along with ≤ 165 mg of aspirin was given daily for 26 weeks. 75 mg of clopidogrel once a day (QD) was allowed at the investigator's discretion. After 547 subjects were randomized to Phase A, an independent Data and Safety Monitoring Board (DSMB) recommended expanding the randomization to 2 higher doses of apixaban (10 mg BID and 20 mg QD) in Phase B of the study. Approximately 6 months after the start of Phase B, the DSMB recommended apixaban high dose groups be terminated due to excess bleeding in those participants receiving aspirin and clopidogrel concomitantly with high dose apixaban. Treatment and any new randomization into these 2 groups was halted, while randomization and treatment in the placebo and lower dose apixaban groups continued. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants).
Periods
Title
Milestones
Reasons Not Completed
Randomized in Phase A (26 Weeks)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Netherlands
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug
Tablets, Oral, 10 mg, once daily, 26 weeks
A2
Placebo
Drug
Tablets, Oral, 0, twice daily, 26 weeks
A3
Apixaban
Drug
Tablets, Oral 10 mg, twice daily, 26 weeks
A4
Randomization to 182 days after randomization (183 days)
Event Rate for Adjudicated All Bleeding Events During the Treatment Period - Treated Participants With Placebo or Apixaban Low Doses
Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events includes major bleeding, clinically relevant non-major bleeding and minor bleeding. Treatment Period refers to the period from first dose through 2 days, or through 30 days for Serious Adverse Event (SAE) tabulations, after discontinuation of study drug. Data in this outcome are combined across Phase A and Phase B.
first dose (Day 1) to last dose plus 2 days (or for SAEs, plus 30 days), up to Year 2 of the Study
Number of Participants With a Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants
Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B
Day of randomization to 182 days after day of randomization (183 days)
Event Rate of Confirmed Adjudicated Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses
Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the Clinical Events Committee. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%).
from first dose (Day 1) to last dose plus 2 days, up to Year 2 of the Study
Number of Participants With Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B
Phase B Adjusted Intended Treatment Period=day of randomization and ends on termination date of high dose apixaban, 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure.
Day of randomization and ends on high dose termination date, 1-Oct-2007
Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Phase B Adjusted Treatment Period- Treated Participants Randomized in Phase B
Bleeding was assessed using ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups and the lower duration of exposure. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group).
From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007
Event Rate for Adjudicated All Bleeding Events During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B
Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events included major bleeding, clinically relevant non-major bleeding and minor bleeding. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group).
From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007
Number of Participants With Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B
Phase B Adjusted Intended Treatment Period=day of randomization and ends on 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure.
Day of randomization up to high dose termination, 1-Oct-2007
Event Rate of Confirmed Adjudicated Major Bleeding During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B
Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%).
From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007
In both Phase A and Phase B of the study: Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants).
FG002
Apixaban 10mg QD
In both Phase A and Phase B of the study: Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants).
FG003
Apixaban 10mg BID
Phase B of the Study: Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Approximately 6 months after the start of Phase B, the DSMB recommended that the 10 mg BID QD group, be terminated due to excess bleeding for participants receiving aspirin and clopidogrel concomitantly with the 10 mg BID apixaban. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants).
FG004
Apixaban 20 mg QD
Phase B of the Study: Tablet of Apixaban 20 mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Approximately 6 months after the start of Phase B, the DSMB recommended that the apixaban 20 mg QD group, be terminated due to excess bleeding for participants receiving aspirin and clopidogrel concomitantly with the apixaban. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants).
FG000184 subjects
FG001179 subjects
FG002184 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG000130 subjects
FG001140 subjects
FG002149 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG00054 subjects
FG00139 subjects
FG00235 subjects
FG0030 subjects
FG0040 subjects
Type
Comment
Reasons
Adverse Event
FG00019 subjects
FG00114 subjects
FG00217 subjects
FG0030 subjects
FG0040 subjects
Withdrawal by Subject
FG00020 subjects
FG00112 subjects
FG00213 subjects
FG0030 subjects
FG004
Death
FG0003 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0004 subjects
FG0014 subjects
FG0022 subjects
FG0030 subjects
FG004
Poor/non-compliance
FG0003 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
no longer meets criteria
FG0004 subjects
FG0013 subjects
FG0022 subjects
FG0030 subjects
FG004
Administrative reason (arm terminated)
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Randomized in Phase B (26 Weeks)
Type
Comment
Milestone Data
STARTED
FG000427 subjects
FG001138 subjects
FG002134 subjects
FG003248 subjects
FG004221 subjects
Start of Phase B to High Dose Terminated
FG000368 subjects
FG001120 subjects
FG002110 subjects
FG003248 subjects
COMPLETED
FG000333 subjects
FG001105 subjects
FG00294 subjects
FG00315 subjects
FG004
NOT COMPLETED
FG00094 subjects
FG00133 subjects
FG00240 subjects
FG003233 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG00034 subjects
FG0019 subjects
FG00212 subjects
FG003
Follow-Up(30days)-Randomized Phase A
Type
Comment
Milestone Data
STARTED
FG000163 subjects
FG001162 subjects
FG002174 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG000158 subjects
FG001156 subjects
FG002172 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0005 subjects
FG0016 subjects
FG0022 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0005 subjects
FG0015 subjects
FG0022 subjects
FG003
Follow-Up(30days)-Randomized Phase B
Type
Comment
Milestone Data
STARTED
FG000383 subjects
FG001123 subjects
FG002119 subjects
FG003222 subjects
FG004201 subjects
COMPLETED
FG000380 subjects
FG001123 subjects
FG002117 subjects
FG003217 subjects
FG004
NOT COMPLETED
FG0003 subjects
FG0010 subjects
FG0022 subjects
FG0035 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG003
All randomized participants were summarized.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Tablet of Placebo for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
BG001
Apixaban 2.5mg BID
Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
BG002
Apixaban 10mg QD
Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
BG003
Apixaban 10mg BID
Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Approximately 6 months after the start of Phase B, this treatment group was terminated
BG004
Apixaban 20 mg QD
Tablet of apixaban, oral, for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Approximately 6 months after the start of Phase B, this treatment group was terminated.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000611
BG001317
BG002318
BG003248
BG004221
BG0051715
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00060.5± 11.25
BG00161.1± 11.64
BG00260.7± 11.35
BG003
Age, Customized
Number
participants
Title
Denominators
Categories
Less than (<) 65 years
Title
Measurements
BG000374
BG001187
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000157
BG00175
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Russian Federation
Title
Measurements
BG000156
BG00193
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses
Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The primary outcome is based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B. The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups (10mg BID, 20mg QD) and the resulting lower duration of exposure for these groups.
Participants who received at least one dose of placebo or low dose apixaban. Due to the premature termination of the 2 apixaban high-dose groups (10 mg BID and 20 mg QD) in Phase B, the primary analyses reported are based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B.
Posted
Number
95% Confidence Interval
percentage of participants
From first dose of study drug (Day 1) to last dose plus 2 days, up to Year 2 of the Study
ID
Title
Description
OG000
Placebo
Tablet of Placebo daily for 26 weeks. Also, less than, equal to (≤) 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
OG001
Apixaban 2.5mg BID
Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
OG002
Apixaban 10mg QD
Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Units
Counts
Participants
OG000599
OG001315
OG002315
Title
Denominators
Categories
Title
Measurements
OG0003.0(1.8 to 4.7)
OG0015.7(3.4 to 8.9)
OG0027.9(5.2 to 11.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Adjusted rate difference
2.2
2-Sided
95
-1.0
5.4
adjusted difference of event rates takes into consideration stratification factors.
No
Superiority or Other
OG000
OG002
Secondary
Number of Participants With a Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants
Events were adjudicated by the Clinical Events Committee (CEC). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B.
Participants who randomized to placebo or low dose apixaban are summarized. Due to the premature termination of the 2 apixaban high-dose groups (10 mg BID and 20 mg QD) in Phase B, the analyses reported are based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B.
Posted
Number
participants
Randomization to 182 days after randomization (183 days)
ID
Title
Description
OG000
Placebo
Tablet of Placebo daily for 26 weeks. Also, less than, equal to (≤) 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
OG001
Apixaban 2.5mg BID
Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
OG002
Secondary
Event Rate for Adjudicated All Bleeding Events During the Treatment Period - Treated Participants With Placebo or Apixaban Low Doses
Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events includes major bleeding, clinically relevant non-major bleeding and minor bleeding. Treatment Period refers to the period from first dose through 2 days, or through 30 days for Serious Adverse Event (SAE) tabulations, after discontinuation of study drug. Data in this outcome are combined across Phase A and Phase B.
Participants who received at least one dose of placebo or low dose apixaban are summarized. The analyses reported are based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B.
Posted
Number
95% Confidence Interval
percentage of participants
first dose (Day 1) to last dose plus 2 days (or for SAEs, plus 30 days), up to Year 2 of the Study
ID
Title
Description
OG000
Placebo
Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
OG001
Apixaban 2.5mg BID
Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Secondary
Number of Participants With a Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants
Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B
Randomized participants were summarized.
Posted
Number
participants
Day of randomization to 182 days after day of randomization (183 days)
ID
Title
Description
OG000
Placebo
Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
OG001
Apixaban 2.5mg BID
Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
OG002
Apixaban 10mg QD
Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Secondary
Event Rate of Confirmed Adjudicated Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses
Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the Clinical Events Committee. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%).
Participants who received at least one dose of placebo or low dose apixaban were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
from first dose (Day 1) to last dose plus 2 days, up to Year 2 of the Study
ID
Title
Description
OG000
Placebo
Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
OG001
Apixaban 2.5mg BID
Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
OG002
Apixaban 10mg QD
Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Secondary
Number of Participants With Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B
Phase B Adjusted Intended Treatment Period=day of randomization and ends on termination date of high dose apixaban, 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure.
Participants who were concomitantly randomized in Phase B only were summarized (start of Phase B, March 2007, to termination of high doses in Phase B, October 2007) .
Posted
Number
participants
Day of randomization and ends on high dose termination date, 1-Oct-2007
ID
Title
Description
OG000
Placebo
Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
OG001
Apixaban 2.5mg BID
Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
OG002
Apixaban 10mg QD
Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Secondary
Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Phase B Adjusted Treatment Period- Treated Participants Randomized in Phase B
Bleeding was assessed using ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups and the lower duration of exposure. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group).
Participants randomized in Phase B only who received at least one dose of placebo or apixaban were summarized.
Posted
Number
95% Confidence Interval
percentage of participants
From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007
ID
Title
Description
OG000
Placebo
Tablet of Placebo, oral, for 26 weeks. Also ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
OG001
Apixaban 2.5mg BID
Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Secondary
Event Rate for Adjudicated All Bleeding Events During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B
Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events included major bleeding, clinically relevant non-major bleeding and minor bleeding. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group).
Participants concomitantly randomized in Phase B who received at least one dose of placebo or apixaban were summarized.
Posted
Number
95% Confidence Interval
percentage of participants
From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007
ID
Title
Description
OG000
Placebo
Tablet of Placebo daily for 26 weeks. Also ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
OG001
Apixaban 2.5mg BID
Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
OG002
Secondary
Number of Participants With Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B
Phase B Adjusted Intended Treatment Period=day of randomization and ends on 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure.
Participants who were concomitantly randomized in Phase B were summarized.
Posted
Number
participants
Day of randomization up to high dose termination, 1-Oct-2007
ID
Title
Description
OG000
Placebo
Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
OG001
Apixaban 2.5mg BID
Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
OG002
Apixaban 10mg QD
Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Secondary
Event Rate of Confirmed Adjudicated Major Bleeding During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B
Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%).
Participants concomitantly randomized in Phase B who received at least one dose of placebo or apixaban were summarized.
Posted
Number
95% Confidence Interval
percentage of participants
From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007
ID
Title
Description
OG000
Placebo
Tablet of Placebo daily for 26 weeks. Also ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
OG001
Apixaban 2.5mg BID
Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
OG002
Apixaban 10mg QD
Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Time Frame
Day 1 up to 30 days post last dose of study drug, up to approximately 2 years: A+B treatment groups. March 2007 up to 30 days post last dose in October 2007 (termination of high doses), are presented in Phase B Treatment groups.
Description
Participants treated with at least 1 dose of study drug are presented. Note: during Phase B, high dose apixaban arms (10 mg BID and 20 mg QD) were terminated but participants could continue to be randomized to Placebo, 2.5 mg BID and 10 mg QD apixaban and treated post termination of the high dose arms (October 2007), up to approximately 2 years.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase A+B Apixaban 10mg QD
Total Phase A and Phase B participants combined who received at least 1 dose of 10 mg QD apixaban during the study.
72
315
122
315
EG001
Phase A+B Apixaban 2.5mg BID
Total Phase A and Phase B participants combined who received at least 1 dose of 2.5 mg BID apixaban during the study.
73
315
101
315
EG002
Phase A+B Placebo
Total Phase A and Phase B participants combined who received at least 1 dose of placebo during the study.
125
599
175
599
EG003
Phase B Apixaban 10mg BID
Participants treated with at least one dose of 10 mg BID apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
55
244
84
244
EG004
Phase B Apixaban 10mg QD
Participants treated with at least one dose of 10 mg QD apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
22
108
30
108
EG005
Phase B Apixaban 20mg QD
Participants treated with at least one dose of 20 mg QD apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
36
218
67
218
EG006
Phase B Apixaban 2.5mg BID
Participants treated with at least one dose of 2.5 mg BID apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
19
119
22
119
EG007
Phase B Placebo
Participants treated with at least one dose of Placebo during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
56
362
80
362
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG0030 affected244 at risk
EG004
Appendicitis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Arterial restenosis
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Breast cancer in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0022 affected599 at risk
EG003
Coronary artery restenosis
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Electrocardiogram change
Investigations
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0011 affected315 at risk
EG0021 affected599 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
In-stent arterial restenosis
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Intervertebral disc disorder
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0022 affected599 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0012 affected315 at risk
EG0020 affected599 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0006 affected315 at risk
EG0018 affected315 at risk
EG00211 affected599 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0005 affected315 at risk
EG0016 affected315 at risk
EG00214 affected599 at risk
EG003
Bladder cancer stage II
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0003 affected315 at risk
EG0010 affected315 at risk
EG0024 affected599 at risk
EG003
Cardiac failure chronic
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Duodenal ulcer haemorrhage
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0021 affected599 at risk
EG003
Eye haemorrhage
Eye disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Lichen planus
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Peripheral vascular disorder
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0002 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Uterine haemorrhage
Reproductive system and breast disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Wound abscess
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Calculus ureteric
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Chest pain
General disorders
MedDRA 11.0
Systematic Assessment
EG0007 affected315 at risk
EG0016 affected315 at risk
EG00213 affected599 at risk
EG003
Coronary artery dissection
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Dyskinesia
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 11.0
Systematic Assessment
EG0002 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Impaired healing
General disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Malaise
General disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0022 affected599 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0021 affected599 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Reflux oesophagitis
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0012 affected315 at risk
EG0020 affected599 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0014 affected315 at risk
EG0024 affected599 at risk
EG003
Aneurysm
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Arteriogram coronary
Investigations
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Cardiac enzymes increased
Investigations
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Depression
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Hypomania
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Ischaemia
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0008 affected315 at risk
EG0014 affected315 at risk
EG00212 affected599 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG00011 affected315 at risk
EG0018 affected315 at risk
EG00224 affected599 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0025 affected599 at risk
EG003
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0012 affected315 at risk
EG0021 affected599 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Acute prerenal failure
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Barrett's oesophagus
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Bladder transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Bundle branch block right
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Campylobacter gastroenteritis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Chest discomfort
General disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Coronary artery occlusion
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Dementia Alzheimer's type
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0023 affected599 at risk
EG003
Endocarditis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Myocardial rupture
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0023 affected599 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Sudden death
General disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0013 affected315 at risk
EG0024 affected599 at risk
EG003
Syncope vasovagal
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Tachyarrhythmia
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Toxic skin eruption
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Uterine polyp
Reproductive system and breast disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Volvulus
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Abdominal symptom
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Angiopathy
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Asthenia
General disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Death
General disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Diabetic gastroparesis
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0021 affected599 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0002 affected315 at risk
EG0011 affected315 at risk
EG0021 affected599 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0013 affected315 at risk
EG0020 affected599 at risk
EG003
Incisional hernia
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Septic shock
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Sudden cardiac death
General disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0022 affected599 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Venous thrombosis limb
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0011 affected315 at risk
EG0022 affected599 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Catheter site haemorrhage
General disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Diplopia
Eye disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Haematoma
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Headache
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 11.0
Systematic Assessment
EG0006 affected315 at risk
EG0012 affected315 at risk
EG0024 affected599 at risk
EG003
Peritonsillar abscess
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Pyrexia
General disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0012 affected315 at risk
EG0020 affected599 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Sick sinus syndrome
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Syncope
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0012 affected315 at risk
EG0021 affected599 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0004 affected315 at risk
EG0013 affected315 at risk
EG0023 affected599 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0013 affected315 at risk
EG0024 affected599 at risk
EG003
Cardiac myxoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Ear haemorrhage
Ear and labyrinth disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Hypertension
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0002 affected315 at risk
EG0013 affected315 at risk
EG0022 affected599 at risk
EG003
Hypotension
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Intermittent claudication
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Lung injury
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0011 affected315 at risk
EG0020 affected599 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0011 affected315 at risk
EG0021 affected599 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected315 at risk
EG0010 affected315 at risk
EG0020 affected599 at risk
EG003
Vascular pseudoaneurysm
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected315 at risk
EG0010 affected315 at risk
EG0021 affected599 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Dizziness
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG00018 affected315 at risk
EG00115 affected315 at risk
EG00235 affected599 at risk
EG00310 affected244 at risk
EG0044 affected108 at risk
EG0059 affected218 at risk
EG0063 affected119 at risk
EG00716 affected362 at risk
Angina pectoris
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG00019 affected315 at risk
EG00118 affected315 at risk
EG00231 affected599 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG00024 affected315 at risk
EG00118 affected315 at risk
EG00218 affected599 at risk
EG003
Chest pain
General disorders
MedDRA 11.0
Systematic Assessment
EG00027 affected315 at risk
EG00121 affected315 at risk
EG00252 affected599 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG00011 affected315 at risk
EG00110 affected315 at risk
EG0029 affected599 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG00026 affected315 at risk
EG00120 affected315 at risk
EG00220 affected599 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG00016 affected315 at risk
EG00113 affected315 at risk
EG00220 affected599 at risk
EG003
Haematoma
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG00016 affected315 at risk
EG00111 affected315 at risk
EG00210 affected599 at risk
EG003
Headache
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG00025 affected315 at risk
EG00117 affected315 at risk
EG00230 affected599 at risk
EG003
Fatigue
General disorders
MedDRA 11.0
Systematic Assessment
EG0008 affected315 at risk
EG00113 affected315 at risk
EG00226 affected599 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Point of Contact
Title
Organization
Phone
Extension
Email
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Clinical.Trials@bms.com
ID
Term
D054058
Acute Coronary Syndrome
Ancestor Terms
ID
Term
D017202
Myocardial Ischemia
D006331
Heart Diseases
D002318
Cardiovascular Diseases
D014652
Vascular Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C522181
apixaban
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
0 subjects
0 subjects
0 subjects
0 subjects
0 subjects
FG004
221 subjects
13 subjects
208 subjects
23 subjects
FG00419 subjects
Withdrawal by Subject
FG00035 subjects
FG00114 subjects
FG00219 subjects
FG00315 subjects
FG00419 subjects
Death
FG0005 subjects
FG0013 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
Lost to Follow-up
FG0005 subjects
FG0012 subjects
FG0023 subjects
FG0032 subjects
FG0043 subjects
poor/non-compliance
FG0003 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
no longer meets criteria
FG0009 subjects
FG0013 subjects
FG0022 subjects
FG0030 subjects
FG0042 subjects
Administrative reason by Sponsor
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG003193 subjects
FG004164 subjects
non-specified
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
0 subjects
0 subjects
0 subjects
FG0040 subjects
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
199 subjects
2 subjects
1 subjects
FG0041 subjects
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0041 subjects
missing end of study status
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
60.3
± 11.00
BG00460.9± 11.95
BG00560.7± 11.38
197
BG003165
BG004132
BG0051055
Greater than, equal to 65 and < 75 years
Title
Measurements
BG000170
BG00185
BG00282
BG00353
BG00457
BG005447
Greater than (>) 75 years
Title
Measurements
BG00067
BG00145
BG00239
BG00330
BG00432
BG005213
86
BG00345
BG00450
BG005413
Male
BG000454
BG001242
BG002232
BG003203
BG004171
BG0051302
82
BG00359
BG00452
BG005442
United States
Title
Measurements
BG00069
BG00140
BG00244
BG00324
BG00414
BG005191
United Kingdom
Title
Measurements
BG00015
BG0017
BG0029
BG0035
BG0045
BG00541
Spain
Title
Measurements
BG00036
BG00111
BG00216
BG00317
BG00419
BG00599
Canada
Title
Measurements
BG00081
BG00147
BG00244
BG00326
BG00421
BG005219
Austria
Title
Measurements
BG0004
BG0012
BG0022
BG0034
BG0042
BG00514
Sweden
Title
Measurements
BG00042
BG00121
BG00224
BG00312
BG00412
BG005111
Belgium
Title
Measurements
BG00020
BG00111
BG0029
BG00310
BG00412
BG00562
Poland
Title
Measurements
BG00061
BG00121
BG00219
BG00334
BG00431
BG005166
Denmark
Title
Measurements
BG00016
BG00114
BG00215
BG0035
BG0044
BG00554
Israel
Title
Measurements
BG00055
BG00129
BG00232
BG00326
BG00421
BG005163
France
Title
Measurements
BG00021
BG0019
BG0028
BG0038
BG00410
BG00556
Germany
Title
Measurements
BG00034
BG00112
BG00214
BG00317
BG00418
BG00595
Italy
Title
Measurements
BG0001
BG0010
BG0020
BG0031
BG0040
BG0052
Adjusted Rate Difference
3.8
2-Sided
95
0.4
7.3
adjusted difference of event rates takes into consideration stratification factors.
No
Superiority or Other
Apixaban 10mg QD
Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Units
Counts
Participants
OG000611
OG001317
OG002318
Title
Denominators
Categories
Title
Measurements
OG00053
OG00124
OG00219
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
0.73
2-Sided
95
0.44
1.19
No
Superiority or Other
OG000
OG002
Hazard Ratio (HR)
0.61
2-Sided
95
0.35
1.04
No
Superiority or Other
OG002
Apixaban 10mg QD
Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Units
Counts
Participants
OG000599
OG001315
OG002315
Title
Denominators
Categories
Title
Measurements
OG00010.5(8.2 to 13.3)
OG00120.6(16.3 to 25.5)
OG00222.5(18.0 to 27.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Adjusted rate difference
6.6
2-Sided
95
1.8
11.3
adjusted difference of event rates takes into consideration stratification factors.
No
Superiority or Other
OG000
OG002
Adjusted Rate Difference
10.0
2-Sided
95
4.8
15.2
adjusted difference of event rates takes into consideration stratification factors.
No
Superiority or Other
Units
Counts
Participants
OG000611
OG001317
OG002318
Title
Denominators
Categories
Title
Measurements
OG00054
OG00124
OG00220
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
0.71
2-Sided
95
0.44
1.17
No
Superiority or Other
OG000
OG002
Hazard Ratio (HR)
0.63
2-Sided
95
0.37
1.07
No
Superiority or Other
Units
Counts
Participants
OG000599
OG001315
OG002315
Title
Denominators
Categories
Title
Measurements
OG0000.8(0.3 to 1.9)
OG0011.6(0.5 to 3.7)
OG0021.9(0.7 to 4.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Adjusted rate difference
0.3
2-Sided
95
-1.3
2.0
adjusted difference of event rates takes into consideration stratification factors.
No
Superiority or Other
OG000
OG002
Adjusted Rate Difference
0.8
2-Sided
95
-1.1
2.7
adjusted difference of event rates takes into consideration stratification factors.
No
Superiority or Other
OG003
Apixaban 10mg BID
Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Approximately 6 months after the start of Phase B this treatment group was terminated.
OG004
Apixaban 20 mg QD
Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Approximately 6 months after the start of Phase B this treatment group was terminated.
Units
Counts
Participants
OG000368
OG001120
OG002110
OG003248
OG004221
Title
Denominators
Categories
Title
Measurements
OG00016
OG0016
OG0024
OG0038
OG0047
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
1.13
2-Sided
95
0.44
2.88
No
Superiority or Other
OG000
OG002
Hazard Ratio (HR)
0.86
2-Sided
95
0.29
2.57
No
Superiority or Other
OG000
OG003
Hazard Ratio (HR)
0.71
2-Sided
95
0.30
1.66
No
Superiority or Other
OG000
OG004
Hazard Ratio (HR)
0.72
2-Sided
95
0.30
1.74
No
Superiority or Other
OG002
Apixaban 10mg QD
Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
OG003
Apixaban 10mg BID
Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Approximately 6 months after the start of Phase B this treatment group was terminated.
OG004
Apixaban 20 mg QD
Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Approximately 6 months after the start of Phase B this treatment group was terminated.
Units
Counts
Participants
OG000362
OG001119
OG002108
OG003244
OG004218
Title
Denominators
Categories
Title
Measurements
OG0000.8(0.2 to 2.4)
OG0015.0(1.9 to 10.7)
OG0025.6(2.1 to 11.7)
OG0037.8(4.8 to 11.9)
OG0047.3(4.3 to 11.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Adjusted Rate Difference
4.0
2-Sided
95
0.0
8.1
No
Superiority or Other
OG000
OG002
Adjusted Rate Difference
4.7
2-Sided
95
0.0
9.3
No
Superiority or Other
OG000
OG003
Adjusted Rate Difference
7.0
2-Sided
95
3.4
10.5
No
Superiority or Other
OG000
OG004
Adjusted Rate Difference
4.7
2-Sided
95
1.4
8.0
No
Superiority or Other
Apixaban 10mg QD
Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
OG003
Apixaban 10mg BID
Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Approximately 6 months after the start of Phase B this treatment group was terminated.
OG004
Apixaban 20 mg QD
Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Approximately 6 months after the start of Phase B this treatment group was terminated.
Units
Counts
Participants
OG000362
OG001119
OG002108
OG003244
OG004218
Title
Denominators
Categories
Title
Measurements
OG0006.1(3.8 to 9.1)
OG00115.1(9.2 to 22.8)
OG00217.6(10.9 to 26.1)
OG00324.2(18.9 to 30.1)
OG00423.9(18.4 to 30.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Adjusted Rate Difference
8.3
2-Sided
95
1.8
14.9
No
Superiority or Other
OG000
OG002
Adjusted Rate Difference
10.9
2-Sided
95
3.4
18.4
No
Superiority or Other
OG000
OG003
Adjusted Rate Difference
17.4
2-Sided
95
11.6
23.2
No
Superiority or Other
OG000
OG004
Adjusted Rate Difference
10.4
2-Sided
95
5.6
15.1
No
Superiority or Other
OG003
Apixaban 10mg BID
Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Approximately 6 months after the start of Phase B this treatment group was terminated.
OG004
Apixaban 20 mg QD
Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Approximately 6 months after the start of Phase B this treatment group was terminated.
Units
Counts
Participants
OG000368
OG001120
OG002110
OG003248
OG004221
Title
Denominators
Categories
Title
Measurements
OG00016
OG0016
OG0024
OG0038
OG0047
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cox Proportional Hazard
1.13
2-Sided
95
0.44
2.88
No
Superiority or Other
OG000
OG002
Cox Proportional Hazard
0.86
2-Sided
95
0.29
2.57
No
Superiority or Other
OG000
OG003
Cox Proportional Hazard
0.71
2-Sided
95
0.30
1.66
No
Superiority or Other
OG000
OG004
Cox Proportional Hazard
0.72
2-Sided
95
0.30
1.74
No
Superiority or Other
OG003
Apixaban 10mg BID
Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Approximately 6 months after the start of Phase B this treatment group was terminated.
OG004
Apixaban 20 mg QD
Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
Approximately 6 months after the start of Phase B this treatment group was terminated.