Trial Outcomes & Findings for Safety Study of Apixaban in Recent Acute Coronary Syndrome (NCT NCT00313300)
NCT ID: NCT00313300
Last Updated: 2015-12-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1741 participants
Primary outcome timeframe
From first dose of study drug (Day 1) to last dose plus 2 days, up to Year 2 of the Study
Results posted on
2015-12-30
Participant Flow
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.
Participant milestones
| Measure |
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).
|
Apixaban 2.5mg BID
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).
|
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).
|
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).
|
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).
|
|---|---|---|---|---|---|
|
Randomized in Phase A (26 Weeks)
STARTED
|
184
|
179
|
184
|
0
|
0
|
|
Randomized in Phase A (26 Weeks)
COMPLETED
|
130
|
140
|
149
|
0
|
0
|
|
Randomized in Phase A (26 Weeks)
NOT COMPLETED
|
54
|
39
|
35
|
0
|
0
|
|
Randomized in Phase B (26 Weeks)
STARTED
|
427
|
138
|
134
|
248
|
221
|
|
Randomized in Phase B (26 Weeks)
Start of Phase B to High Dose Terminated
|
368
|
120
|
110
|
248
|
221
|
|
Randomized in Phase B (26 Weeks)
COMPLETED
|
333
|
105
|
94
|
15
|
13
|
|
Randomized in Phase B (26 Weeks)
NOT COMPLETED
|
94
|
33
|
40
|
233
|
208
|
|
Follow-Up(30days)-Randomized Phase A
STARTED
|
163
|
162
|
174
|
0
|
0
|
|
Follow-Up(30days)-Randomized Phase A
COMPLETED
|
158
|
156
|
172
|
0
|
0
|
|
Follow-Up(30days)-Randomized Phase A
NOT COMPLETED
|
5
|
6
|
2
|
0
|
0
|
|
Follow-Up(30days)-Randomized Phase B
STARTED
|
383
|
123
|
119
|
222
|
201
|
|
Follow-Up(30days)-Randomized Phase B
COMPLETED
|
380
|
123
|
117
|
217
|
199
|
|
Follow-Up(30days)-Randomized Phase B
NOT COMPLETED
|
3
|
0
|
2
|
5
|
2
|
Reasons for withdrawal
| Measure |
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).
|
Apixaban 2.5mg BID
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).
|
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).
|
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).
|
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).
|
|---|---|---|---|---|---|
|
Randomized in Phase A (26 Weeks)
Adverse Event
|
19
|
14
|
17
|
0
|
0
|
|
Randomized in Phase A (26 Weeks)
Withdrawal by Subject
|
20
|
12
|
13
|
0
|
0
|
|
Randomized in Phase A (26 Weeks)
Death
|
3
|
4
|
0
|
0
|
0
|
|
Randomized in Phase A (26 Weeks)
Lost to Follow-up
|
4
|
4
|
2
|
0
|
0
|
|
Randomized in Phase A (26 Weeks)
Poor/non-compliance
|
3
|
2
|
1
|
0
|
0
|
|
Randomized in Phase A (26 Weeks)
no longer meets criteria
|
4
|
3
|
2
|
0
|
0
|
|
Randomized in Phase A (26 Weeks)
Administrative reason (arm terminated)
|
1
|
0
|
0
|
0
|
0
|
|
Randomized in Phase B (26 Weeks)
Adverse Event
|
34
|
9
|
12
|
23
|
19
|
|
Randomized in Phase B (26 Weeks)
Withdrawal by Subject
|
35
|
14
|
19
|
15
|
19
|
|
Randomized in Phase B (26 Weeks)
Death
|
5
|
3
|
1
|
0
|
1
|
|
Randomized in Phase B (26 Weeks)
Lost to Follow-up
|
5
|
2
|
3
|
2
|
3
|
|
Randomized in Phase B (26 Weeks)
poor/non-compliance
|
3
|
1
|
3
|
0
|
0
|
|
Randomized in Phase B (26 Weeks)
no longer meets criteria
|
9
|
3
|
2
|
0
|
2
|
|
Randomized in Phase B (26 Weeks)
Administrative reason by Sponsor
|
2
|
1
|
0
|
193
|
164
|
|
Randomized in Phase B (26 Weeks)
non-specified
|
1
|
0
|
0
|
0
|
0
|
|
Follow-Up(30days)-Randomized Phase A
Withdrawal by Subject
|
5
|
5
|
2
|
0
|
0
|
|
Follow-Up(30days)-Randomized Phase A
Death
|
0
|
1
|
0
|
0
|
0
|
|
Follow-Up(30days)-Randomized Phase B
Withdrawal by Subject
|
1
|
0
|
2
|
1
|
1
|
|
Follow-Up(30days)-Randomized Phase B
Death
|
1
|
0
|
0
|
0
|
0
|
|
Follow-Up(30days)-Randomized Phase B
Lost to Follow-up
|
0
|
0
|
0
|
2
|
1
|
|
Follow-Up(30days)-Randomized Phase B
missing end of study status
|
1
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Safety Study of Apixaban in Recent Acute Coronary Syndrome
Baseline characteristics by cohort
| Measure |
Placebo
n=611 Participants
Tablet of Placebo for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.
|
Apixaban 2.5mg BID
n=317 Participants
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.
|
Apixaban 10mg QD
n=318 Participants
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.
|
Apixaban 10mg BID
n=248 Participants
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
|
Apixaban 20 mg QD
n=221 Participants
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.
|
Total
n=1715 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 11.25 • n=5 Participants
|
61.1 years
STANDARD_DEVIATION 11.64 • n=7 Participants
|
60.7 years
STANDARD_DEVIATION 11.35 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 11.00 • n=4 Participants
|
60.9 years
STANDARD_DEVIATION 11.95 • n=21 Participants
|
60.7 years
STANDARD_DEVIATION 11.38 • n=8 Participants
|
|
Age, Customized
Less than (<) 65 years
|
374 participants
n=5 Participants
|
187 participants
n=7 Participants
|
197 participants
n=5 Participants
|
165 participants
n=4 Participants
|
132 participants
n=21 Participants
|
1055 participants
n=8 Participants
|
|
Age, Customized
Greater than, equal to 65 and < 75 years
|
170 participants
n=5 Participants
|
85 participants
n=7 Participants
|
82 participants
n=5 Participants
|
53 participants
n=4 Participants
|
57 participants
n=21 Participants
|
447 participants
n=8 Participants
|
|
Age, Customized
Greater than (>) 75 years
|
67 participants
n=5 Participants
|
45 participants
n=7 Participants
|
39 participants
n=5 Participants
|
30 participants
n=4 Participants
|
32 participants
n=21 Participants
|
213 participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
157 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
413 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
454 Participants
n=5 Participants
|
242 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
203 Participants
n=4 Participants
|
171 Participants
n=21 Participants
|
1302 Participants
n=8 Participants
|
|
Region of Enrollment
Russian Federation
|
156 participants
n=5 Participants
|
93 participants
n=7 Participants
|
82 participants
n=5 Participants
|
59 participants
n=4 Participants
|
52 participants
n=21 Participants
|
442 participants
n=8 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=5 Participants
|
40 participants
n=7 Participants
|
44 participants
n=5 Participants
|
24 participants
n=4 Participants
|
14 participants
n=21 Participants
|
191 participants
n=8 Participants
|
|
Region of Enrollment
United Kingdom
|
15 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
5 participants
n=4 Participants
|
5 participants
n=21 Participants
|
41 participants
n=8 Participants
|
|
Region of Enrollment
Spain
|
36 participants
n=5 Participants
|
11 participants
n=7 Participants
|
16 participants
n=5 Participants
|
17 participants
n=4 Participants
|
19 participants
n=21 Participants
|
99 participants
n=8 Participants
|
|
Region of Enrollment
Canada
|
81 participants
n=5 Participants
|
47 participants
n=7 Participants
|
44 participants
n=5 Participants
|
26 participants
n=4 Participants
|
21 participants
n=21 Participants
|
219 participants
n=8 Participants
|
|
Region of Enrollment
Austria
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
2 participants
n=21 Participants
|
14 participants
n=8 Participants
|
|
Region of Enrollment
Sweden
|
42 participants
n=5 Participants
|
21 participants
n=7 Participants
|
24 participants
n=5 Participants
|
12 participants
n=4 Participants
|
12 participants
n=21 Participants
|
111 participants
n=8 Participants
|
|
Region of Enrollment
Belgium
|
20 participants
n=5 Participants
|
11 participants
n=7 Participants
|
9 participants
n=5 Participants
|
10 participants
n=4 Participants
|
12 participants
n=21 Participants
|
62 participants
n=8 Participants
|
|
Region of Enrollment
Poland
|
61 participants
n=5 Participants
|
21 participants
n=7 Participants
|
19 participants
n=5 Participants
|
34 participants
n=4 Participants
|
31 participants
n=21 Participants
|
166 participants
n=8 Participants
|
|
Region of Enrollment
Denmark
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
15 participants
n=5 Participants
|
5 participants
n=4 Participants
|
4 participants
n=21 Participants
|
54 participants
n=8 Participants
|
|
Region of Enrollment
Israel
|
55 participants
n=5 Participants
|
29 participants
n=7 Participants
|
32 participants
n=5 Participants
|
26 participants
n=4 Participants
|
21 participants
n=21 Participants
|
163 participants
n=8 Participants
|
|
Region of Enrollment
France
|
21 participants
n=5 Participants
|
9 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
10 participants
n=21 Participants
|
56 participants
n=8 Participants
|
|
Region of Enrollment
Germany
|
34 participants
n=5 Participants
|
12 participants
n=7 Participants
|
14 participants
n=5 Participants
|
17 participants
n=4 Participants
|
18 participants
n=21 Participants
|
95 participants
n=8 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug (Day 1) to last dose plus 2 days, up to Year 2 of the StudyPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=599 Participants
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.
|
Apixaban 2.5mg BID
n=315 Participants
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.
|
Apixaban 10mg QD
n=315 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
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
|
3.0 percentage of participants
Interval 1.8 to 4.7
|
5.7 percentage of participants
Interval 3.4 to 8.9
|
7.9 percentage of participants
Interval 5.2 to 11.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Randomization to 182 days after randomization (183 days)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=611 Participants
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.
|
Apixaban 2.5mg BID
n=317 Participants
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.
|
Apixaban 10mg QD
n=318 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
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
|
53 participants
|
24 participants
|
19 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: first dose (Day 1) to last dose plus 2 days (or for SAEs, plus 30 days), up to Year 2 of the StudyPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=599 Participants
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.
|
Apixaban 2.5mg BID
n=315 Participants
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.
|
Apixaban 10mg QD
n=315 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Event Rate for Adjudicated All Bleeding Events During the Treatment Period - Treated Participants With Placebo or Apixaban Low Doses
|
10.5 percentage of participants
Interval 8.2 to 13.3
|
20.6 percentage of participants
Interval 16.3 to 25.5
|
22.5 percentage of participants
Interval 18.0 to 27.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Day of randomization to 182 days after day of randomization (183 days)Population: Randomized participants were summarized.
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
Outcome measures
| Measure |
Placebo
n=611 Participants
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.
|
Apixaban 2.5mg BID
n=317 Participants
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.
|
Apixaban 10mg QD
n=318 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
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
|
54 participants
|
24 participants
|
20 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: from first dose (Day 1) to last dose plus 2 days, up to Year 2 of the StudyPopulation: Participants who received at least one dose of placebo or low dose apixaban were analyzed.
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 (%).
Outcome measures
| Measure |
Placebo
n=599 Participants
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.
|
Apixaban 2.5mg BID
n=315 Participants
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.
|
Apixaban 10mg QD
n=315 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Event Rate of Confirmed Adjudicated Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses
|
0.8 percentage of participants
Interval 0.3 to 1.9
|
1.6 percentage of participants
Interval 0.5 to 3.7
|
1.9 percentage of participants
Interval 0.7 to 4.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Day of randomization and ends on high dose termination date, 1-Oct-2007Population: 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) .
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.
Outcome measures
| Measure |
Placebo
n=368 Participants
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.
|
Apixaban 2.5mg BID
n=120 Participants
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.
|
Apixaban 10mg QD
n=110 Participants
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.
|
Apixaban 10mg BID
n=248 Participants
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.
|
Apixaban 20 mg QD
n=221 Participants
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.
|
|---|---|---|---|---|---|
|
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
|
16 participants
|
6 participants
|
4 participants
|
8 participants
|
7 participants
|
SECONDARY outcome
Timeframe: From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007Population: Participants randomized in Phase B only who received at least one dose of placebo or apixaban were summarized.
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).
Outcome measures
| Measure |
Placebo
n=362 Participants
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.
|
Apixaban 2.5mg BID
n=119 Participants
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.
|
Apixaban 10mg QD
n=108 Participants
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.
|
Apixaban 10mg BID
n=244 Participants
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.
|
Apixaban 20 mg QD
n=218 Participants
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.
|
|---|---|---|---|---|---|
|
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
|
0.8 percentage of participants
Interval 0.2 to 2.4
|
5.0 percentage of participants
Interval 1.9 to 10.7
|
5.6 percentage of participants
Interval 2.1 to 11.7
|
7.8 percentage of participants
Interval 4.8 to 11.9
|
7.3 percentage of participants
Interval 4.3 to 11.6
|
SECONDARY outcome
Timeframe: From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007Population: Participants concomitantly randomized in Phase B who received at least one dose of placebo or apixaban were summarized.
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).
Outcome measures
| Measure |
Placebo
n=362 Participants
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.
|
Apixaban 2.5mg BID
n=119 Participants
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.
|
Apixaban 10mg QD
n=108 Participants
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.
|
Apixaban 10mg BID
n=244 Participants
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.
|
Apixaban 20 mg QD
n=218 Participants
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.
|
|---|---|---|---|---|---|
|
Event Rate for Adjudicated All Bleeding Events During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B
|
6.1 percentage of participants
Interval 3.8 to 9.1
|
15.1 percentage of participants
Interval 9.2 to 22.8
|
17.6 percentage of participants
Interval 10.9 to 26.1
|
24.2 percentage of participants
Interval 18.9 to 30.1
|
23.9 percentage of participants
Interval 18.4 to 30.1
|
SECONDARY outcome
Timeframe: Day of randomization up to high dose termination, 1-Oct-2007Population: Participants who were concomitantly randomized in Phase B were summarized.
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.
Outcome measures
| Measure |
Placebo
n=368 Participants
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.
|
Apixaban 2.5mg BID
n=120 Participants
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.
|
Apixaban 10mg QD
n=110 Participants
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.
|
Apixaban 10mg BID
n=248 Participants
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.
|
Apixaban 20 mg QD
n=221 Participants
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.
|
|---|---|---|---|---|---|
|
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
|
16 participants
|
6 participants
|
4 participants
|
8 participants
|
7 participants
|
SECONDARY outcome
Timeframe: From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007Population: Participants concomitantly randomized in Phase B who received at least one dose of placebo or apixaban were summarized.
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 (%).
Outcome measures
| Measure |
Placebo
n=362 Participants
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.
|
Apixaban 2.5mg BID
n=119 Participants
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.
|
Apixaban 10mg QD
n=108 Participants
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.
|
Apixaban 10mg BID
n=244 Participants
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.
|
Apixaban 20 mg QD
n=218 Participants
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.
|
|---|---|---|---|---|---|
|
Event Rate of Confirmed Adjudicated Major Bleeding During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B
|
0.0 percentage of participants
Interval 0.0 to 1.0
|
0.8 percentage of participants
Interval 0.0 to 4.6
|
0.0 percentage of participants
Interval 0.0 to 3.4
|
2.9 percentage of participants
Interval 1.2 to 5.8
|
4.1 percentage of participants
Interval 1.9 to 7.7
|
Adverse Events
Phase A+B Apixaban 10mg QD
Serious events: 72 serious events
Other events: 122 other events
Deaths: 0 deaths
Phase A+B Apixaban 2.5mg BID
Serious events: 73 serious events
Other events: 101 other events
Deaths: 0 deaths
Phase A+B Placebo
Serious events: 125 serious events
Other events: 175 other events
Deaths: 0 deaths
Phase B Apixaban 10mg BID
Serious events: 55 serious events
Other events: 84 other events
Deaths: 0 deaths
Phase B Apixaban 10mg QD
Serious events: 22 serious events
Other events: 30 other events
Deaths: 0 deaths
Phase B Apixaban 20mg QD
Serious events: 36 serious events
Other events: 67 other events
Deaths: 0 deaths
Phase B Apixaban 2.5mg BID
Serious events: 19 serious events
Other events: 22 other events
Deaths: 0 deaths
Phase B Placebo
Serious events: 56 serious events
Other events: 80 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase A+B Apixaban 10mg QD
n=315 participants at risk
Total Phase A and Phase B participants combined who received at least 1 dose of 10 mg QD apixaban during the study.
|
Phase A+B Apixaban 2.5mg BID
n=315 participants at risk
Total Phase A and Phase B participants combined who received at least 1 dose of 2.5 mg BID apixaban during the study.
|
Phase A+B Placebo
n=599 participants at risk
Total Phase A and Phase B participants combined who received at least 1 dose of placebo during the study.
|
Phase B Apixaban 10mg BID
n=244 participants at risk
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)
|
Phase B Apixaban 10mg QD
n=108 participants at risk
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)
|
Phase B Apixaban 20mg QD
n=218 participants at risk
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)
|
Phase B Apixaban 2.5mg BID
n=119 participants at risk
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)
|
Phase B Placebo
n=362 participants at risk
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)
|
|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.93%
1/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Vascular disorders
Arterial restenosis
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.93%
1/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Infections and infestations
Bronchitis
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.93%
1/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.33%
2/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.84%
1/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Cardiac disorders
Coronary artery restenosis
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Investigations
Electrocardiogram change
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Infections and infestations
Gastroenteritis
|
0.32%
1/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.33%
2/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.93%
1/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.32%
1/315 • 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.
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.
|
0.63%
2/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.93%
1/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.84%
1/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Cardiac disorders
Angina pectoris
|
1.9%
6/315 • 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.
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.
|
2.5%
8/315 • 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.
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.
|
1.8%
11/599 • 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.
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.
|
2.0%
5/244 • 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.
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.
|
0.93%
1/108 • 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.
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.
|
1.4%
3/218 • 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.
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.
|
1.7%
2/119 • 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.
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.
|
1.1%
4/362 • 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.
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.
|
|
Cardiac disorders
Angina unstable
|
1.6%
5/315 • 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.
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.
|
1.9%
6/315 • 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.
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.
|
2.3%
14/599 • 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.
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.
|
2.0%
5/244 • 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.
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.
|
1.9%
2/108 • 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.
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.
|
1.4%
3/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
1.7%
6/362 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage II
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Cardiac disorders
Cardiac failure
|
0.95%
3/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.67%
4/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.83%
3/362 • 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.
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.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.92%
2/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Infections and infestations
Postoperative wound infection
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.32%
1/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.84%
1/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.63%
2/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Infections and infestations
Wound abscess
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
General disorders
Chest pain
|
2.2%
7/315 • 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.
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.
|
1.9%
6/315 • 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.
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.
|
2.2%
13/599 • 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.
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.
|
2.9%
7/244 • 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.
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.
|
1.9%
2/108 • 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.
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.
|
2.8%
6/218 • 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.
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.
|
0.84%
1/119 • 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.
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.
|
2.2%
8/362 • 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.
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.
|
|
Cardiac disorders
Coronary artery dissection
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.93%
1/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Investigations
Haemoglobin decreased
|
0.63%
2/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
General disorders
Impaired healing
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
General disorders
Malaise
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.33%
2/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.84%
1/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/315 • 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.
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.
|
0.63%
2/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.84%
1/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.93%
1/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.32%
1/315 • 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.
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.
|
1.3%
4/315 • 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.
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.
|
0.67%
4/599 • 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.
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.
|
1.2%
3/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.84%
1/119 • 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.
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.
|
0.55%
2/362 • 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.
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.
|
|
Vascular disorders
Aneurysm
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Investigations
Arteriogram coronary
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Investigations
Cardiac enzymes increased
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.93%
1/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Psychiatric disorders
Depression
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.93%
1/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Psychiatric disorders
Hypomania
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Vascular disorders
Ischaemia
|
2.5%
8/315 • 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.
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.
|
1.3%
4/315 • 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.
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.
|
2.0%
12/599 • 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.
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.
|
1.6%
4/244 • 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.
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.
|
1.9%
2/108 • 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.
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.
|
2.8%
6/218 • 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.
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.
|
0.84%
1/119 • 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.
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.
|
1.4%
5/362 • 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.
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.
|
|
Cardiac disorders
Myocardial infarction
|
3.5%
11/315 • 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.
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.
|
2.5%
8/315 • 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.
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.
|
4.0%
24/599 • 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.
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.
|
1.2%
3/244 • 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.
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.
|
2.8%
3/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.84%
1/119 • 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.
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.
|
3.3%
12/362 • 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.
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.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.83%
5/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
1.1%
4/362 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/315 • 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.
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.
|
0.63%
2/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.84%
1/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.93%
1/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.93%
1/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Cardiac disorders
Bundle branch block right
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.84%
1/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
General disorders
Chest discomfort
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.50%
3/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Infections and infestations
Endocarditis
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.93%
1/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.84%
1/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.82%
2/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.84%
1/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Cardiac disorders
Myocardial rupture
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.50%
3/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
General disorders
Sudden death
|
0.00%
0/315 • 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.
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.
|
0.95%
3/315 • 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.
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.
|
0.67%
4/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.84%
1/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Vascular disorders
Thrombosis
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.84%
1/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Abdominal symptom
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Vascular disorders
Angiopathy
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
General disorders
Asthenia
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.93%
1/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Reproductive system and breast disorders
Breast pain
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.93%
1/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Cardiac disorders
Cardiac failure acute
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.93%
1/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
General disorders
Death
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.93%
1/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
1.2%
3/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.84%
1/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Renal and urinary disorders
Haematuria
|
0.63%
2/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/315 • 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.
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.
|
0.95%
3/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.84%
1/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Infections and infestations
Septic shock
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.33%
2/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.55%
2/362 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.32%
1/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.33%
2/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
General disorders
Catheter site haemorrhage
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Eye disorders
Diplopia
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Vascular disorders
Haematoma
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Nervous system disorders
Headache
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
General disorders
Non-cardiac chest pain
|
1.9%
6/315 • 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.
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.
|
0.63%
2/315 • 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.
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.
|
0.67%
4/599 • 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.
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.
|
2.0%
5/244 • 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.
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.
|
2.8%
3/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.55%
2/362 • 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.
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.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
General disorders
Pyrexia
|
0.00%
0/315 • 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.
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.
|
0.63%
2/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
1.7%
2/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Renal and urinary disorders
Renal failure
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.93%
1/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Nervous system disorders
Syncope
|
0.32%
1/315 • 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.
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.
|
0.63%
2/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
4/315 • 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.
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.
|
0.95%
3/315 • 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.
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.
|
0.50%
3/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.93%
1/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.84%
1/119 • 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.
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.
|
0.55%
2/362 • 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.
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.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/315 • 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.
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.
|
0.95%
3/315 • 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.
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.
|
0.67%
4/599 • 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.
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.
|
0.82%
2/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac myxoma
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Vascular disorders
Hypertension
|
0.63%
2/315 • 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.
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.
|
0.95%
3/315 • 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.
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.
|
0.33%
2/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.84%
1/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Vascular disorders
Hypotension
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Injury, poisoning and procedural complications
Lung injury
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.41%
1/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.32%
1/315 • 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.
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.
|
0.32%
1/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.93%
1/108 • 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.
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.
|
0.46%
1/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.28%
1/362 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.32%
1/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.00%
0/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/315 • 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.
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.
|
0.00%
0/315 • 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.
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.
|
0.17%
1/599 • 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.
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.
|
0.00%
0/244 • 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.
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.
|
0.00%
0/108 • 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.
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.
|
0.00%
0/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
0.00%
0/362 • 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.
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.
|
Other adverse events
| Measure |
Phase A+B Apixaban 10mg QD
n=315 participants at risk
Total Phase A and Phase B participants combined who received at least 1 dose of 10 mg QD apixaban during the study.
|
Phase A+B Apixaban 2.5mg BID
n=315 participants at risk
Total Phase A and Phase B participants combined who received at least 1 dose of 2.5 mg BID apixaban during the study.
|
Phase A+B Placebo
n=599 participants at risk
Total Phase A and Phase B participants combined who received at least 1 dose of placebo during the study.
|
Phase B Apixaban 10mg BID
n=244 participants at risk
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)
|
Phase B Apixaban 10mg QD
n=108 participants at risk
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)
|
Phase B Apixaban 20mg QD
n=218 participants at risk
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)
|
Phase B Apixaban 2.5mg BID
n=119 participants at risk
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)
|
Phase B Placebo
n=362 participants at risk
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)
|
|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
5.7%
18/315 • 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.
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.
|
4.8%
15/315 • 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.
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.
|
5.8%
35/599 • 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.
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.
|
4.1%
10/244 • 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.
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.
|
3.7%
4/108 • 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.
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.
|
4.1%
9/218 • 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.
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.
|
2.5%
3/119 • 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.
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.
|
4.4%
16/362 • 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.
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.
|
|
Cardiac disorders
Angina pectoris
|
6.0%
19/315 • 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.
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.
|
5.7%
18/315 • 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.
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.
|
5.2%
31/599 • 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.
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.
|
4.1%
10/244 • 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.
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.
|
4.6%
5/108 • 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.
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.
|
5.0%
11/218 • 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.
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.
|
2.5%
3/119 • 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.
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.
|
3.3%
12/362 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.6%
24/315 • 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.
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.
|
5.7%
18/315 • 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.
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.
|
3.0%
18/599 • 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.
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.
|
6.6%
16/244 • 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.
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.
|
4.6%
5/108 • 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.
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.
|
11.5%
25/218 • 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.
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.
|
3.4%
4/119 • 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.
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.
|
0.55%
2/362 • 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.
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.
|
|
General disorders
Chest pain
|
8.6%
27/315 • 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.
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.
|
6.7%
21/315 • 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.
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.
|
8.7%
52/599 • 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.
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.
|
7.8%
19/244 • 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.
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.
|
8.3%
9/108 • 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.
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.
|
6.4%
14/218 • 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.
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.
|
3.4%
4/119 • 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.
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.
|
6.6%
24/362 • 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.
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.
|
|
Gastrointestinal disorders
Gingival bleeding
|
3.5%
11/315 • 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.
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.
|
3.2%
10/315 • 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.
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.
|
1.5%
9/599 • 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.
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.
|
6.1%
15/244 • 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.
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.
|
1.9%
2/108 • 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.
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.
|
3.7%
8/218 • 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.
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.
|
3.4%
4/119 • 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.
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.
|
1.1%
4/362 • 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.
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
26/315 • 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.
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.
|
6.3%
20/315 • 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.
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.
|
3.3%
20/599 • 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.
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.
|
4.9%
12/244 • 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.
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.
|
3.7%
4/108 • 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.
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.
|
4.6%
10/218 • 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.
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.
|
3.4%
4/119 • 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.
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.
|
2.8%
10/362 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.1%
16/315 • 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.
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.
|
4.1%
13/315 • 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.
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.
|
3.3%
20/599 • 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.
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.
|
1.2%
3/244 • 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.
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.
|
5.6%
6/108 • 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.
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.
|
1.8%
4/218 • 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.
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.
|
3.4%
4/119 • 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.
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.
|
2.8%
10/362 • 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.
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.
|
|
Vascular disorders
Haematoma
|
5.1%
16/315 • 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.
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.
|
3.5%
11/315 • 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.
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.
|
1.7%
10/599 • 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.
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.
|
3.7%
9/244 • 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.
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.
|
4.6%
5/108 • 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.
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.
|
4.1%
9/218 • 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.
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.
|
3.4%
4/119 • 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.
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.
|
1.4%
5/362 • 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.
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.
|
|
Nervous system disorders
Headache
|
7.9%
25/315 • 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.
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.
|
5.4%
17/315 • 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.
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.
|
5.0%
30/599 • 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.
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.
|
6.1%
15/244 • 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.
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.
|
1.9%
2/108 • 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.
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.
|
2.8%
6/218 • 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.
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.
|
0.00%
0/119 • 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.
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.
|
3.3%
12/362 • 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.
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.
|
|
General disorders
Fatigue
|
2.5%
8/315 • 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.
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.
|
4.1%
13/315 • 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.
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.
|
4.3%
26/599 • 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.
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.
|
6.6%
16/244 • 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.
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.
|
0.93%
1/108 • 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.
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.
|
2.8%
6/218 • 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.
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.
|
3.4%
4/119 • 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.
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.
|
3.9%
14/362 • 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.
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER