Trial Outcomes & Findings for A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation (NCT NCT00787150)
NCT ID: NCT00787150
Last Updated: 2013-05-01
Results Overview
Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
222 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2013-05-01
Participant Flow
Participant milestones
| Measure |
Warfarin
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
|
Apixaban 2.5mg BID
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
Apixaban 5.0 mg BID
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
75
|
72
|
71
|
|
Overall Study
COMPLETED
|
66
|
65
|
66
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
5
|
Reasons for withdrawal
| Measure |
Warfarin
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
|
Apixaban 2.5mg BID
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
Apixaban 5.0 mg BID
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
4
|
4
|
|
Overall Study
Physician Decision
|
1
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
|
Overall Study
Dosing incorrect study durg
|
2
|
0
|
0
|
Baseline Characteristics
A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Warfarin
n=74 Participants
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
|
Apixaban 2.5mg BID
n=74 Participants
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
Apixaban 5.0 mg BID
n=74 Participants
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
71.7 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
69.3 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
70.0 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
70.3 years
STANDARD_DEVIATION 7.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
184 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.
Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.
Outcome measures
| Measure |
Warfarin
n=75 Participants
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
|
Apixaban 2.5mg BID
n=72 Participants
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
Apixaban 5.0 mg BID
n=71 Participants
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
|---|---|---|---|
|
Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period
|
4 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.
Total bleeding events consisted of major (per International Society on Thrombosis and Haemostasis \[ISTH\] Criteria), clinically relevant non-major and minor bleeding events. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding were classified as minor bleeding.
Outcome measures
| Measure |
Warfarin
n=75 Participants
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
|
Apixaban 2.5mg BID
n=72 Participants
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
Apixaban 5.0 mg BID
n=71 Participants
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
|---|---|---|---|
|
Number of Participants With Total Bleeding Events During the Treatment Period
|
13 participants
|
9 participants
|
17 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.
Major bleeding event is acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding is also major bleeding event.
Outcome measures
| Measure |
Warfarin
n=75 Participants
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
|
Apixaban 2.5mg BID
n=72 Participants
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
Apixaban 5.0 mg BID
n=71 Participants
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
|---|---|---|---|
|
Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.
Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.
Outcome measures
| Measure |
Warfarin
n=75 Participants
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
|
Apixaban 2.5mg BID
n=72 Participants
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
Apixaban 5.0 mg BID
n=71 Participants
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
|---|---|---|---|
|
Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period
|
3 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.
The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.
Outcome measures
| Measure |
Warfarin
n=74 Participants
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
|
Apixaban 2.5mg BID
n=74 Participants
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
Apixaban 5.0 mg BID
n=74 Participants
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
|---|---|---|---|
|
Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period
|
3 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.
The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.
Outcome measures
| Measure |
Warfarin
n=74 Participants
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
|
Apixaban 2.5mg BID
n=74 Participants
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
Apixaban 5.0 mg BID
n=74 Participants
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
|---|---|---|---|
|
Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period
|
3 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.
The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.
Outcome measures
| Measure |
Warfarin
n=74 Participants
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
|
Apixaban 2.5mg BID
n=74 Participants
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
Apixaban 5.0 mg BID
n=74 Participants
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
|---|---|---|---|
|
Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period
|
0 participants
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0, 2, 4 hours postdose at Week 1 and Week 8Population: The pharmacokinetic analysis set was defined as participants treated with apixaban, who were not assessed as major protocol violators, and in whom at least one observation of plasma apixaban concentration. n=number of participants with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.
Sample at 4 hours postdose was to be taken if possible.
Outcome measures
| Measure |
Warfarin
n=72 Participants
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
|
Apixaban 2.5mg BID
n=71 Participants
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
Apixaban 5.0 mg BID
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
|---|---|---|---|
|
Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban
0 hour post dose at Week 1 (n=68, 70)
|
53.31 ng/mL
Standard Deviation 28.55
|
119.34 ng/mL
Standard Deviation 50.83
|
—
|
|
Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban
2 hours post dose at Week 1 (n=68, 70)
|
99.43 ng/mL
Standard Deviation 44.65
|
201.80 ng/mL
Standard Deviation 95.58
|
—
|
|
Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban
4 hours post dose at Week 1 (n=38, 35)
|
104.09 ng/mL
Standard Deviation 44.48
|
224.40 ng/mL
Standard Deviation 77.06
|
—
|
|
Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban
0 hour post dose at Week 8 (n=67, 66)
|
62.83 ng/mL
Standard Deviation 37.27
|
137.79 ng/mL
Standard Deviation 54.91
|
—
|
|
Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban
2 hours post dose at Week 8 (n=67, 66)
|
120.16 ng/mL
Standard Deviation 57.79
|
250.53 ng/mL
Standard Deviation 81.35
|
—
|
|
Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban
4 hours post dose at Week 8 (n=35, 29)
|
110.58 ng/mL
Standard Deviation 49.96
|
244.55 ng/mL
Standard Deviation 84.27
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8Population: The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.
Sample at 4 hours postdose was to be taken if possible.
Outcome measures
| Measure |
Warfarin
n=72 Participants
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
|
Apixaban 2.5mg BID
n=71 Participants
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
Apixaban 5.0 mg BID
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
|---|---|---|---|
|
Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban
Week 0 (n=72, 71)
|
14.54 second
Standard Deviation 2.20
|
14.41 second
Standard Deviation 2.06
|
—
|
|
Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban
0 hour post dose at Week 1 (n=67, 70)
|
12.22 second
Standard Deviation 1.56
|
12.54 second
Standard Deviation 0.79
|
—
|
|
Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban
2 hours post dose at Week 1 (n=68, 70)
|
12.46 second
Standard Deviation 0.72
|
13.28 second
Standard Deviation 1.05
|
—
|
|
Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban
4 hours post dose at Week 1 (n=38, 35)
|
12.36 second
Standard Deviation 0.67
|
13.48 second
Standard Deviation 0.82
|
—
|
|
Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban
0 hour post dose at Week 8 (n=67, 66)
|
12.09 second
Standard Deviation 0.73
|
12.74 second
Standard Deviation 0.87
|
—
|
|
Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban
2 hours post dose at Week 8 (n=67, 66)
|
12.68 second
Standard Deviation 0.82
|
13.83 second
Standard Deviation 1.03
|
—
|
|
Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban
4 hours post dose at Week 8 (n=35, 29)
|
12.47 second
Standard Deviation 0.75
|
13.85 second
Standard Deviation 1.07
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8Population: The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.
Blood sample at 4 hours postdose was collected if possible. PT-INR is a standardized measure derived from prothrombin time (PT). The systematic variations in PT assay results are corrected in PT-INR in order to optimize measurements of vitamin K antagonists.
Outcome measures
| Measure |
Warfarin
n=72 Participants
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
|
Apixaban 2.5mg BID
n=71 Participants
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
Apixaban 5.0 mg BID
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
|---|---|---|---|
|
Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban
Week 0 (n=72, 71)
|
1.76 International normalized ratio
Standard Deviation 0.46
|
1.72 International normalized ratio
Standard Deviation 0.43
|
—
|
|
Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban
0 hour post dose at Week 1 (n=67, 70)
|
1.30 International normalized ratio
Standard Deviation 0.37
|
1.34 International normalized ratio
Standard Deviation 0.15
|
—
|
|
Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban
2 hours post dose at Week 1 (n=68, 70)
|
1.33 International normalized ratio
Standard Deviation 0.14
|
1.48 International normalized ratio
Standard Deviation 0.21
|
—
|
|
Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban
4 hours post dose at Week 1 (n=38, 35)
|
1.30 International normalized ratio
Standard Deviation 0.12
|
1.51 International normalized ratio
Standard Deviation 0.18
|
—
|
|
Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban
0 hour post dose at Week 8 (n=67, 66)
|
1.27 International normalized ratio
Standard Deviation 0.14
|
1.38 International normalized ratio
Standard Deviation 0.17
|
—
|
|
Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban
2 hours post dose at Week 8 (n=67, 66)
|
1.37 International normalized ratio
Standard Deviation 0.16
|
1.61 International normalized ratio
Standard Deviation 0.20
|
—
|
|
Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban
4 hours post dose at Week 8 (n=35, 29)
|
1.34 International normalized ratio
Standard Deviation 0.15
|
1.59 International normalized ratio
Standard Deviation 0.22
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8Population: The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.
Blood Sample at 4 hours postdose was collected if possible. The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects.
Outcome measures
| Measure |
Warfarin
n=72 Participants
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
|
Apixaban 2.5mg BID
n=71 Participants
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
Apixaban 5.0 mg BID
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
|---|---|---|---|
|
Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban
Week 0 (n=72, 71)
|
34.51 Second
Standard Deviation 5.05
|
32.98 Second
Standard Deviation 4.39
|
—
|
|
Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban
0 hour post dose at Week 1 (n=67, 70)
|
33.26 Second
Standard Deviation 10.24
|
33.24 Second
Standard Deviation 4.28
|
—
|
|
Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban
2 hours post dose at Week 1 (n=68, 70)
|
33.04 Second
Standard Deviation 3.57
|
35.19 Second
Standard Deviation 4.42
|
—
|
|
Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban
4 hours oist dose at Week 1 (n=38, 35)
|
32.00 Second
Standard Deviation 3.49
|
35.36 Second
Standard Deviation 5.44
|
—
|
|
Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban
0 hour post dose at Week 8 (n=67, 66)
|
33.83 Second
Standard Deviation 5.18
|
35.65 Second
Standard Deviation 4.32
|
—
|
|
Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban
2 hours post dose at Week 8 (n=67, 66)
|
34.67 Second
Standard Deviation 4.39
|
37.92 Second
Standard Deviation 4.78
|
—
|
|
Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban
4 hours post dose at Week 8 (n=35, 29)
|
32.75 Second
Standard Deviation 3.86
|
36.46 Second
Standard Deviation 5.19
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8Population: The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.
Blood sample at 4 hours postdose was collected if possible. Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not be calculated. Therefore, 0 means not calculated.
Outcome measures
| Measure |
Warfarin
n=72 Participants
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
|
Apixaban 2.5mg BID
n=71 Participants
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
Apixaban 5.0 mg BID
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
|---|---|---|---|
|
Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban
Week 0 (n=72, 71)
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
—
|
|
Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban
0 hour post dose at Week 1 (n=68, 69)
|
45.29 ng/mL
Standard Deviation 26.77
|
111.19 ng/mL
Standard Deviation 49.02
|
—
|
|
Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban
2 hours post dose at Week 1 (n=68, 70)
|
94.90 ng/mL
Standard Deviation 45.23
|
187.58 ng/mL
Standard Deviation 85.72
|
—
|
|
Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban
4 hours post dose at Week 1 (n=38, 35)
|
99.07 ng/mL
Standard Deviation 44.46
|
213.24 ng/mL
Standard Deviation 67.54
|
—
|
|
Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban
0 hour post dose at Week 8 (n=67, 65)
|
56.81 ng/mL
Standard Deviation 37.34
|
130.12 ng/mL
Standard Deviation 52.20
|
—
|
|
Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban
2 hours post dose at Week 8 (n=67, 66)
|
114.97 ng/mL
Standard Deviation 56.25
|
236.36 ng/mL
Standard Deviation 88.08
|
—
|
|
Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban
4 hours post dose at Week 8 (n=35, 29)
|
103.61 ng/mL
Standard Deviation 44.54
|
237.78 ng/mL
Standard Deviation 78.58
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0, Week 1, Week 8Population: The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Warfarin, Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.
Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not calculated. Therefore, 0 indicates not calculated.
Outcome measures
| Measure |
Warfarin
n=75 Participants
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
|
Apixaban 2.5mg BID
n=72 Participants
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
Apixaban 5.0 mg BID
n=71 Participants
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
|---|---|---|---|
|
Mean Prothrombin Fragment 1+2 (F1+2) at Each Time Point in Participants Treated With Warfarin or Apixaban
Week 0 (n=75, 72, 71)
|
144.0 pmol/L
Standard Deviation 345.2
|
0 pmol/L
Standard Deviation 0
|
91.4 pmol/L
Standard Deviation 115.3
|
|
Mean Prothrombin Fragment 1+2 (F1+2) at Each Time Point in Participants Treated With Warfarin or Apixaban
Week 1 (n=75, 68, 70)
|
100.4 pmol/L
Standard Deviation 139.0
|
133.8 pmol/L
Standard Deviation 105.5
|
137.0 pmol/L
Standard Deviation 255.5
|
|
Mean Prothrombin Fragment 1+2 (F1+2) at Each Time Point in Participants Treated With Warfarin or Apixaban
Week 8 (n=68, 67, 66)
|
0 pmol/L
Standard Deviation 0
|
152.9 pmol/L
Standard Deviation 79.7
|
121.1 pmol/L
Standard Deviation 56.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0, Week 1, Week 8Population: The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of participants with evaluable data in Warfarin, Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.
Below the limit of quantification (BLQ) was assigned the value 0 for calculation.
Outcome measures
| Measure |
Warfarin
n=75 Participants
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
|
Apixaban 2.5mg BID
n=72 Participants
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
Apixaban 5.0 mg BID
n=71 Participants
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
|---|---|---|---|
|
Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban
Week 0 (n=75, 72, 71)
|
240.4 ng/mL
Standard Deviation 333.5
|
297.8 ng/mL
Standard Deviation 634.6
|
196.4 ng/mL
Standard Deviation 181.4
|
|
Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban
Week 1 (n=75, 68, 70)
|
245.2 ng/mL
Standard Deviation 325.7
|
209.9 ng/mL
Standard Deviation 202.6
|
237.0 ng/mL
Standard Deviation 314.3
|
|
Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban
Week 8 (n=68, 67, 66)
|
209.9 ng/mL
Standard Deviation 201.1
|
227.0 ng/mL
Standard Deviation 253.5
|
203.5 ng/mL
Standard Deviation 190.6
|
Adverse Events
Warfarin
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Apixaban 2.5mg BID
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Apixaban 5.0 mg BID
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Warfarin
n=75 participants at risk
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
|
Apixaban 2.5mg BID
n=72 participants at risk
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
Apixaban 5.0 mg BID
n=71 participants at risk
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Accidental overdose
|
1.3%
1/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.4%
1/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.4%
1/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.4%
1/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.4%
1/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.4%
1/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cerebral infarction
|
2.7%
2/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
1.3%
1/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.4%
1/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Arterial stenosis limb
|
0.00%
0/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.4%
1/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Warfarin
n=75 participants at risk
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
|
Apixaban 2.5mg BID
n=72 participants at risk
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
Apixaban 5.0 mg BID
n=71 participants at risk
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.8%
2/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.8%
2/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.2%
3/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.4%
1/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
0.00%
0/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.8%
2/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.4%
1/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.8%
2/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
9.3%
7/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
11.1%
8/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
11.3%
8/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.3%
1/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.8%
2/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.8%
2/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.8%
2/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.4%
1/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatine phophkinase increased
|
0.00%
0/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.8%
2/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.8%
2/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood urine present
|
5.3%
4/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.4%
1/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.2%
3/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
1.3%
1/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.8%
2/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.8%
2/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.4%
1/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
4/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.6%
4/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.6%
4/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.8%
2/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Blood pressure inadequately controlled
|
2.7%
2/75
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/72
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/71
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER