Trial Outcomes & Findings for Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement (NCT NCT00107900)
NCT ID: NCT00107900
Last Updated: 2019-02-26
Results Overview
The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment (approximately 2 weeks post surgery). Confirmed deep vein thrombosis ( both proximal and distal ) as assessed by unilateral or bilateral ascending contrast venograms 7 to 10 days following surgery Symptomatic and objectively proven Pulmonary Embolism (PE) prior to venography Symptomatic and objectively proven Deep Vein Thrombosis (DVT) prior to venography
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
606 participants
Primary outcome timeframe
2 weeks
Results posted on
2019-02-26
Participant Flow
Participant milestones
| Measure |
15mg BID
15mg edoxaban administered twice daily (BID)
|
30mg QD
30mg edoxaban administered once daily (QD)
|
30mg BID
30mg edoxaban administered twice daily (BID)
|
60mg QD
60mg edoxaban administered once daily (QD)
|
60mg BID
60mg edoxaban administered twice daily (BID)
|
120mg QD
120mg edoxaban administered once daily (QD)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
85
|
75
|
129
|
99
|
115
|
103
|
|
Overall Study
COMPLETED
|
75
|
72
|
104
|
87
|
94
|
94
|
|
Overall Study
NOT COMPLETED
|
10
|
3
|
25
|
12
|
21
|
9
|
Reasons for withdrawal
| Measure |
15mg BID
15mg edoxaban administered twice daily (BID)
|
30mg QD
30mg edoxaban administered once daily (QD)
|
30mg BID
30mg edoxaban administered twice daily (BID)
|
60mg QD
60mg edoxaban administered once daily (QD)
|
60mg BID
60mg edoxaban administered twice daily (BID)
|
120mg QD
120mg edoxaban administered once daily (QD)
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
10
|
3
|
5
|
3
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
3
|
2
|
5
|
5
|
|
Overall Study
Protocol Violation
|
1
|
0
|
5
|
5
|
7
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
5
|
0
|
1
|
1
|
|
Overall Study
Administrative Reasons
|
1
|
0
|
2
|
2
|
2
|
0
|
Baseline Characteristics
Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement
Baseline characteristics by cohort
| Measure |
15mg BID
n=85 Participants
15mg edoxaban administered twice daily (BID)
|
30mg QD
n=75 Participants
30mg edoxaban administered once daily (QD)
|
30mg BID
n=129 Participants
30mg edoxaban administered twice daily (BID)
|
60mg QD
n=99 Participants
60mg edoxaban administered once daily (QD)
|
60mg BID
n=115 Participants
60mg edoxaban administered twice daily (BID)
|
120mg QD
n=103 Participants
120mg edoxaban administered once daily (QD)
|
Total
n=606 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 10.71 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 11.06 • n=7 Participants
|
60.1 years
STANDARD_DEVIATION 13.09 • n=5 Participants
|
58.6 years
STANDARD_DEVIATION 11.90 • n=4 Participants
|
58.8 years
STANDARD_DEVIATION 12.80 • n=21 Participants
|
56.5 years
STANDARD_DEVIATION 12.83 • n=8 Participants
|
58.5 years
STANDARD_DEVIATION 12.25 • n=8 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
72 Participants
n=8 Participants
|
396 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
210 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
56 Participants
n=8 Participants
|
350 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
47 Participants
n=8 Participants
|
256 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
84 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
108 Participants
n=21 Participants
|
99 Participants
n=8 Participants
|
578 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
194 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
65 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
76 Participants
n=8 Participants
|
400 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
11 participants
n=7 Participants
|
89 participants
n=5 Participants
|
24 participants
n=4 Participants
|
35 participants
n=21 Participants
|
27 participants
n=8 Participants
|
206 participants
n=8 Participants
|
|
Region of Enrollment
Europe
|
65 participants
n=5 Participants
|
64 participants
n=7 Participants
|
40 participants
n=5 Participants
|
75 participants
n=4 Participants
|
80 participants
n=21 Participants
|
76 participants
n=8 Participants
|
400 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: modified ITT population
The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment (approximately 2 weeks post surgery). Confirmed deep vein thrombosis ( both proximal and distal ) as assessed by unilateral or bilateral ascending contrast venograms 7 to 10 days following surgery Symptomatic and objectively proven Pulmonary Embolism (PE) prior to venography Symptomatic and objectively proven Deep Vein Thrombosis (DVT) prior to venography
Outcome measures
| Measure |
15mg BID
n=68 Participants
15mg edoxaban administered twice daily (BID)
|
30mg QD
n=65 Participants
30mg edoxaban administered once daily (QD)
|
30mg BID
n=97 Participants
30mg edoxaban administered twice daily (BID)
|
60mg QD
n=73 Participants
60mg edoxaban administered once daily (QD)
|
60mg BID
n=84 Participants
60mg edoxaban administered twice daily (BID)
|
120mg QD
n=80 Participants
120mg edoxaban administered once daily (QD)
|
|---|---|---|---|---|---|---|
|
Prevention of Venous Thromboembolism (VTE)
|
13 percentage of patients with event
Interval 11.7 to 28.7
|
13 percentage of patients with event
Interval 12.3 to 29.9
|
10 percentage of patients with event
Interval 5.7 to 16.9
|
13 percentage of patients with event
Interval 10.9 to 26.8
|
16 percentage of patients with event
Interval 12.3 to 27.5
|
17 percentage of patients with event
Interval 14.0 to 30.2
|
SECONDARY outcome
Timeframe: end of treatmentPopulation: ITT population
Intent to Treat (ITT) population
Outcome measures
| Measure |
15mg BID
n=72 Participants
15mg edoxaban administered twice daily (BID)
|
30mg QD
n=72 Participants
30mg edoxaban administered once daily (QD)
|
30mg BID
n=86 Participants
30mg edoxaban administered twice daily (BID)
|
60mg QD
n=84 Participants
60mg edoxaban administered once daily (QD)
|
60mg BID
n=95 Participants
60mg edoxaban administered twice daily (BID)
|
120mg QD
n=91 Participants
120mg edoxaban administered once daily (QD)
|
|---|---|---|---|---|---|---|
|
Change From Baseline for Prothrombin Time (PT) Results
|
-.2 seconds
Standard Deviation 2.3
|
-.1 seconds
Standard Deviation 2.7
|
.7 seconds
Standard Deviation 1.3
|
.8 seconds
Standard Deviation 2.0
|
1.1 seconds
Standard Deviation 1.9
|
1.8 seconds
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: end of treatmentPopulation: ITT population
Intent to Treat (ITT) population
Outcome measures
| Measure |
15mg BID
n=72 Participants
15mg edoxaban administered twice daily (BID)
|
30mg QD
n=72 Participants
30mg edoxaban administered once daily (QD)
|
30mg BID
n=86 Participants
30mg edoxaban administered twice daily (BID)
|
60mg QD
n=84 Participants
60mg edoxaban administered once daily (QD)
|
60mg BID
n=95 Participants
60mg edoxaban administered twice daily (BID)
|
120mg QD
n=91 Participants
120mg edoxaban administered once daily (QD)
|
|---|---|---|---|---|---|---|
|
Change From Baseline for International Normalized Ratio (INR) Results
|
0 INR ratio
Standard Deviation .2
|
0 INR ratio
Standard Deviation .3
|
.1 INR ratio
Standard Deviation .1
|
.1 INR ratio
Standard Deviation .2
|
.1 INR ratio
Standard Deviation .2
|
.2 INR ratio
Standard Deviation .4
|
SECONDARY outcome
Timeframe: end of treatmentPopulation: ITT population
Intent to Treat (ITT) population
Outcome measures
| Measure |
15mg BID
n=72 Participants
15mg edoxaban administered twice daily (BID)
|
30mg QD
n=72 Participants
30mg edoxaban administered once daily (QD)
|
30mg BID
n=87 Participants
30mg edoxaban administered twice daily (BID)
|
60mg QD
n=84 Participants
60mg edoxaban administered once daily (QD)
|
60mg BID
n=94 Participants
60mg edoxaban administered twice daily (BID)
|
120mg QD
n=91 Participants
120mg edoxaban administered once daily (QD)
|
|---|---|---|---|---|---|---|
|
Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results
|
-5.1 seconds
Standard Deviation 22.0
|
-1.6 seconds
Standard Deviation 25.3
|
2.5 seconds
Standard Deviation 9.8
|
4.1 seconds
Standard Deviation 17.0
|
5.8 seconds
Standard Deviation 16.1
|
11.3 seconds
Standard Deviation 23.1
|
Adverse Events
15mg BID
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
30mg QD
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
30mg BID
Serious events: 9 serious events
Other events: 65 other events
Deaths: 0 deaths
60mg QD
Serious events: 10 serious events
Other events: 56 other events
Deaths: 0 deaths
60mg BID
Serious events: 10 serious events
Other events: 66 other events
Deaths: 0 deaths
120mg QD
Serious events: 4 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
15mg BID
n=85 participants at risk
15mg edoxaban administered twice daily (BID)
|
30mg QD
n=75 participants at risk
30mg edoxaban administered once daily (QD)
|
30mg BID
n=129 participants at risk
30mg edoxaban administered twice daily (BID)
|
60mg QD
n=99 participants at risk
60mg edoxaban administered once daily (QD)
|
60mg BID
n=115 participants at risk
60mg edoxaban administered twice daily (BID)
|
120mg QD
n=103 participants at risk
120mg edoxaban administered once daily (QD)
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
obstructive inguinal hernia
|
1.2%
1/85 • Number of events 1
|
0.00%
0/75
|
0.00%
0/129
|
0.00%
0/99
|
0.00%
0/115
|
0.00%
0/103
|
|
Injury, poisoning and procedural complications
dislocation of joint prosthesis
|
1.2%
1/85 • Number of events 1
|
0.00%
0/75
|
0.78%
1/129 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
0.87%
1/115 • Number of events 1
|
0.00%
0/103
|
|
Vascular disorders
haematoma
|
1.2%
1/85 • Number of events 1
|
0.00%
0/75
|
0.78%
1/129 • Number of events 1
|
0.00%
0/99
|
0.87%
1/115 • Number of events 1
|
0.00%
0/103
|
|
Infections and infestations
wound infection
|
1.2%
1/85 • Number of events 1
|
0.00%
0/75
|
0.00%
0/129
|
1.0%
1/99 • Number of events 1
|
0.00%
0/115
|
0.97%
1/103 • Number of events 1
|
|
Cardiac disorders
atrial fibrillation
|
1.2%
1/85 • Number of events 1
|
0.00%
0/75
|
0.00%
0/129
|
0.00%
0/99
|
0.00%
0/115
|
0.00%
0/103
|
|
Infections and infestations
postoperative wound infection
|
0.00%
0/85
|
1.3%
1/75 • Number of events 1
|
0.00%
0/129
|
2.0%
2/99 • Number of events 2
|
0.87%
1/115 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
|
Investigations
haemoglobin decreased
|
0.00%
0/85
|
1.3%
1/75 • Number of events 1
|
0.00%
0/129
|
0.00%
0/99
|
0.00%
0/115
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.00%
0/85
|
1.3%
1/75 • Number of events 1
|
0.78%
1/129 • Number of events 1
|
2.0%
2/99 • Number of events 2
|
0.87%
1/115 • Number of events 1
|
0.00%
0/103
|
|
Injury, poisoning and procedural complications
hip fracture
|
0.00%
0/85
|
1.3%
1/75 • Number of events 1
|
0.00%
0/129
|
0.00%
0/99
|
0.00%
0/115
|
0.00%
0/103
|
|
Gastrointestinal disorders
gastrointestinal haemorrhage
|
0.00%
0/85
|
0.00%
0/75
|
0.78%
1/129 • Number of events 1
|
0.00%
0/99
|
0.00%
0/115
|
0.00%
0/103
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
0.00%
0/85
|
0.00%
0/75
|
0.78%
1/129 • Number of events 1
|
0.00%
0/99
|
0.00%
0/115
|
0.00%
0/103
|
|
Investigations
blood alkaline phosphatase abnormal
|
0.00%
0/85
|
0.00%
0/75
|
0.78%
1/129 • Number of events 1
|
0.00%
0/99
|
0.00%
0/115
|
0.00%
0/103
|
|
Investigations
alanine aminotransferase abnormal
|
0.00%
0/85
|
0.00%
0/75
|
0.78%
1/129 • Number of events 1
|
0.00%
0/99
|
0.00%
0/115
|
0.00%
0/103
|
|
Investigations
blood bilirubin abnormal
|
0.00%
0/85
|
0.00%
0/75
|
0.78%
1/129 • Number of events 1
|
0.00%
0/99
|
0.00%
0/115
|
0.00%
0/103
|
|
Investigations
aspartate amniotransferase abnormal
|
0.00%
0/85
|
0.00%
0/75
|
0.78%
1/129 • Number of events 1
|
0.00%
0/99
|
0.00%
0/115
|
0.00%
0/103
|
|
Gastrointestinal disorders
rectal haemorrhage
|
0.00%
0/85
|
0.00%
0/75
|
0.78%
1/129 • Number of events 1
|
0.00%
0/99
|
0.00%
0/115
|
0.00%
0/103
|
|
Investigations
hepatic enzyme increase
|
0.00%
0/85
|
0.00%
0/75
|
0.78%
1/129 • Number of events 1
|
0.00%
0/99
|
0.00%
0/115
|
0.00%
0/103
|
|
Nervous system disorders
sciatic nerve palsy
|
0.00%
0/85
|
0.00%
0/75
|
0.00%
0/129
|
1.0%
1/99 • Number of events 1
|
0.00%
0/115
|
0.00%
0/103
|
|
Injury, poisoning and procedural complications
snake bite
|
0.00%
0/85
|
0.00%
0/75
|
0.00%
0/129
|
1.0%
1/99 • Number of events 1
|
0.00%
0/115
|
0.00%
0/103
|
|
Injury, poisoning and procedural complications
contrast media reaction
|
0.00%
0/85
|
0.00%
0/75
|
0.00%
0/129
|
1.0%
1/99 • Number of events 1
|
0.00%
0/115
|
0.00%
0/103
|
|
Vascular disorders
wound haemorrhage
|
0.00%
0/85
|
0.00%
0/75
|
0.00%
0/129
|
1.0%
1/99 • Number of events 1
|
0.87%
1/115 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
|
Injury, poisoning and procedural complications
postprocedural fistula
|
0.00%
0/85
|
0.00%
0/75
|
0.00%
0/129
|
0.00%
0/99
|
0.87%
1/115 • Number of events 1
|
0.00%
0/103
|
|
Nervous system disorders
acute psychosis
|
0.00%
0/85
|
0.00%
0/75
|
0.00%
0/129
|
0.00%
0/99
|
0.87%
1/115 • Number of events 1
|
0.00%
0/103
|
|
Injury, poisoning and procedural complications
anemia postoperative
|
0.00%
0/85
|
0.00%
0/75
|
0.00%
0/129
|
0.00%
0/99
|
0.87%
1/115 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
|
Blood and lymphatic system disorders
lymphadentis
|
0.00%
0/85
|
0.00%
0/75
|
0.00%
0/129
|
0.00%
0/99
|
0.87%
1/115 • Number of events 1
|
0.00%
0/103
|
|
Infections and infestations
infection
|
0.00%
0/85
|
0.00%
0/75
|
0.00%
0/129
|
0.00%
0/99
|
1.7%
2/115 • Number of events 2
|
0.00%
0/103
|
|
Injury, poisoning and procedural complications
hip arthroplasty
|
0.00%
0/85
|
0.00%
0/75
|
0.00%
0/129
|
0.00%
0/99
|
0.87%
1/115 • Number of events 1
|
0.00%
0/103
|
|
Investigations
alanine aminotransferase increase
|
0.00%
0/85
|
0.00%
0/75
|
0.00%
0/129
|
0.00%
0/99
|
0.87%
1/115 • Number of events 1
|
0.00%
0/103
|
|
Investigations
blood alkaline phosphatase increase
|
0.00%
0/85
|
0.00%
0/75
|
0.00%
0/129
|
0.00%
0/99
|
0.87%
1/115 • Number of events 1
|
0.00%
0/103
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/85
|
0.00%
0/75
|
0.00%
0/129
|
0.00%
0/99
|
0.87%
1/115 • Number of events 1
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
0.00%
0/85
|
0.00%
0/75
|
0.00%
0/129
|
0.00%
0/99
|
0.87%
1/115 • Number of events 1
|
0.00%
0/103
|
|
Gastrointestinal disorders
pancreatitis
|
0.00%
0/85
|
0.00%
0/75
|
0.00%
0/129
|
0.00%
0/99
|
0.00%
0/115
|
0.97%
1/103 • Number of events 1
|
|
Nervous system disorders
tremor
|
0.00%
0/85
|
0.00%
0/75
|
0.00%
0/129
|
0.00%
0/99
|
0.00%
0/115
|
0.97%
1/103 • Number of events 1
|
|
Nervous system disorders
anxiety
|
0.00%
0/85
|
0.00%
0/75
|
0.00%
0/129
|
0.00%
0/99
|
0.00%
0/115
|
0.97%
1/103 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/85
|
0.00%
0/75
|
0.00%
0/129
|
0.00%
0/99
|
0.00%
0/115
|
0.97%
1/103 • Number of events 1
|
|
Vascular disorders
pallor
|
0.00%
0/85
|
0.00%
0/75
|
0.00%
0/129
|
0.00%
0/99
|
0.00%
0/115
|
0.97%
1/103 • Number of events 1
|
Other adverse events
| Measure |
15mg BID
n=85 participants at risk
15mg edoxaban administered twice daily (BID)
|
30mg QD
n=75 participants at risk
30mg edoxaban administered once daily (QD)
|
30mg BID
n=129 participants at risk
30mg edoxaban administered twice daily (BID)
|
60mg QD
n=99 participants at risk
60mg edoxaban administered once daily (QD)
|
60mg BID
n=115 participants at risk
60mg edoxaban administered twice daily (BID)
|
120mg QD
n=103 participants at risk
120mg edoxaban administered once daily (QD)
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
tachycardia
|
1.2%
1/85
|
1.3%
1/75
|
0.78%
1/129
|
7.1%
7/99
|
2.6%
3/115
|
2.9%
3/103
|
|
Gastrointestinal disorders
constipation
|
3.5%
3/85
|
5.3%
4/75
|
18.6%
24/129
|
7.1%
7/99
|
10.4%
12/115
|
7.8%
8/103
|
|
Gastrointestinal disorders
nausea
|
3.5%
3/85
|
2.7%
2/75
|
7.0%
9/129
|
6.1%
6/99
|
7.0%
8/115
|
3.9%
4/103
|
|
General disorders
hyperthermia
|
9.4%
8/85
|
6.7%
5/75
|
3.9%
5/129
|
27.3%
27/99
|
20.0%
23/115
|
8.7%
9/103
|
|
General disorders
oedema peripheral
|
7.1%
6/85
|
4.0%
3/75
|
9.3%
12/129
|
4.0%
4/99
|
9.6%
11/115
|
4.9%
5/103
|
|
General disorders
pyrexia
|
3.5%
3/85
|
5.3%
4/75
|
17.8%
23/129
|
10.1%
10/99
|
9.6%
11/115
|
8.7%
9/103
|
|
Injury, poisoning and procedural complications
procedural pain
|
1.2%
1/85
|
2.7%
2/75
|
2.3%
3/129
|
3.0%
3/99
|
5.2%
6/115
|
0.00%
0/103
|
|
Investigations
activated partial thromboplastin time prolonged
|
0.00%
0/85
|
1.3%
1/75
|
0.00%
0/129
|
13.1%
13/99
|
4.3%
5/115
|
5.8%
6/103
|
|
Investigations
prothrombin time prolonged
|
0.00%
0/85
|
0.00%
0/75
|
0.00%
0/129
|
15.2%
15/99
|
2.6%
3/115
|
3.9%
4/103
|
|
Nervous system disorders
dizziness
|
1.2%
1/85
|
0.00%
0/75
|
5.4%
7/129
|
4.0%
4/99
|
2.6%
3/115
|
0.97%
1/103
|
|
Nervous system disorders
headache
|
0.00%
0/85
|
1.3%
1/75
|
7.0%
9/129
|
1.0%
1/99
|
3.5%
4/115
|
1.9%
2/103
|
|
Psychiatric disorders
insomnia
|
0.00%
0/85
|
0.00%
0/75
|
7.0%
9/129
|
5.1%
5/99
|
4.3%
5/115
|
0.00%
0/103
|
|
Blood and lymphatic system disorders
anaemia
|
2.4%
2/85
|
4.0%
3/75
|
6.2%
8/129
|
2.0%
2/99
|
8.7%
10/115
|
7.8%
8/103
|
|
Injury, poisoning and procedural complications
anaemia post-operative
|
3.5%
3/85
|
1.3%
1/75
|
3.9%
5/129
|
5.1%
5/99
|
4.3%
5/115
|
0.97%
1/103
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A study site may not publish results of a study until after a coordinated multicenter publication has been submitted for publication or until one year after the study has ended, whichever occurs first. The study site will have the opportunity to publish results of the study, provided Daiichi Sankyo has had the opportunity to review and comment on the study site's proposed publication prior to being submitted for publication with the advice of patent council and need for subject protection.
- Publication restrictions are in place
Restriction type: OTHER