Trial Outcomes & Findings for Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation (NCT NCT00684307)
NCT ID: NCT00684307
Last Updated: 2012-03-23
Results Overview
Number of patients with a bleeding event while on study drug. Patients with multiple events are counted once
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1084 participants
Primary outcome timeframe
36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)
Results posted on
2012-03-23
Participant Flow
The study population included male and female participants \>18 years of age with chronic non-valvular Atrial Fibrillation. The participants were recruited during the time period from 20 February 2007 to 5 June 2008 at medical clinics in Europe.
Participants were enrolled in the study up to two weeks before randomisation and treatment assignment. Participants that were already treated with Vitamin K Antagonists (VKA) at the time of enrollment had their dose adjusted to achive INR \<2.0 at the time of randomisation. If this was not achieved the participant was discontinued from the study.
Participant milestones
| Measure |
150 mg od
AZD0837 150 mg od
|
300 mg od
AZD0837 300 mg od
|
450 mg od
AZD0837 450 mg od
|
200 mg bd
AZD0837 200 mg bd
|
VKA INR 2-3
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
164
|
151
|
156
|
160
|
318
|
|
Overall Study
On Treatment Period Started
|
164
|
151
|
156
|
160
|
318
|
|
Overall Study
On Treatment Period Completed
|
140
|
129
|
128
|
128
|
293
|
|
Overall Study
COMPLETED
|
140
|
129
|
128
|
128
|
293
|
|
Overall Study
NOT COMPLETED
|
24
|
22
|
28
|
32
|
25
|
Reasons for withdrawal
| Measure |
150 mg od
AZD0837 150 mg od
|
300 mg od
AZD0837 300 mg od
|
450 mg od
AZD0837 450 mg od
|
200 mg bd
AZD0837 200 mg bd
|
VKA INR 2-3
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
11
|
6
|
15
|
16
|
8
|
|
Overall Study
Development of increasing Liver Function
|
0
|
2
|
0
|
1
|
0
|
|
Overall Study
Fullfillment of exclusion criteria
|
1
|
0
|
0
|
3
|
1
|
|
Overall Study
Incorrect enrolment or randomization
|
4
|
0
|
0
|
0
|
0
|
|
Overall Study
Interupted IP for more than 7 days
|
0
|
4
|
1
|
3
|
3
|
|
Overall Study
Severe non compliance to protocol
|
1
|
0
|
0
|
1
|
2
|
|
Overall Study
Participant not willing to continue
|
7
|
10
|
11
|
5
|
8
|
|
Overall Study
Criteria from the CSR
|
0
|
0
|
1
|
3
|
3
|
Baseline Characteristics
Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
150 mg od
n=164 Participants
AZD0837 150 mg od
|
300 mg od
n=151 Participants
AZD0837 300 mg od
|
450 mg od
n=156 Participants
AZD0837 450 mg od
|
200 mg bd
n=160 Participants
AZD0837 200 mg bd
|
VKA INR 2-3
n=318 Participants
|
Total
n=949 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age Continuous
|
9.0 Years
STANDARD_DEVIATION 69.9 • n=5 Participants
|
9.0 Years
STANDARD_DEVIATION 69.8 • n=7 Participants
|
9.4 Years
STANDARD_DEVIATION 69.3 • n=5 Participants
|
9.4 Years
STANDARD_DEVIATION 67.8 • n=4 Participants
|
9.1 Years
STANDARD_DEVIATION 68.3 • n=21 Participants
|
9.18 Years
STANDARD_DEVIATION 69.02 • n=8 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
299 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
215 Participants
n=21 Participants
|
650 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)Number of patients with a bleeding event while on study drug. Patients with multiple events are counted once
Outcome measures
| Measure |
150 mg od
n=164 Participants
AZD0837 150 mg od
|
300 mg od
n=151 Participants
AZD0837 300 mg od
|
450 mg od
n=156 Participants
AZD0837 450 mg od
|
200 mg bd
n=160 Participants
AZD0837 200 mg bd
|
VKA INR 2-3
n=318 Participants
|
|---|---|---|---|---|---|
|
Bleeding Events
|
18 Participants
|
8 Participants
|
22 Participants
|
17 Participants
|
46 Participants
|
PRIMARY outcome
Timeframe: 12 weeks according to protocol.(baseline to week 12 visit)Change in Creatinine values from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline)
Outcome measures
| Measure |
150 mg od
n=141 Participants
AZD0837 150 mg od
|
300 mg od
n=132 Participants
AZD0837 300 mg od
|
450 mg od
n=133 Participants
AZD0837 450 mg od
|
200 mg bd
n=134 Participants
AZD0837 200 mg bd
|
VKA INR 2-3
n=298 Participants
|
|---|---|---|---|---|---|
|
Creatinine
|
5.95 umol/L
Standard Deviation 11.18
|
4.81 umol/L
Standard Deviation 12.74
|
7.56 umol/L
Standard Deviation 14.95
|
9.22 umol/L
Standard Deviation 11.24
|
0.43 umol/L
Standard Deviation 11.79
|
PRIMARY outcome
Timeframe: 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)Number of patients while on study drug with ALAT\>=3 times upper limit of normal.l
Outcome measures
| Measure |
150 mg od
n=156 Participants
AZD0837 150 mg od
|
300 mg od
n=147 Participants
AZD0837 300 mg od
|
450 mg od
n=150 Participants
AZD0837 450 mg od
|
200 mg bd
n=152 Participants
AZD0837 200 mg bd
|
VKA INR 2-3
n=315 Participants
|
|---|---|---|---|---|---|
|
Alanine Aminotransferase (ALAT)
|
6 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)Number of patients while on study drug with Bilirubin\>=2 times upper limit of normal
Outcome measures
| Measure |
150 mg od
n=156 Participants
AZD0837 150 mg od
|
300 mg od
n=147 Participants
AZD0837 300 mg od
|
450 mg od
n=150 Participants
AZD0837 450 mg od
|
200 mg bd
n=152 Participants
AZD0837 200 mg bd
|
VKA INR 2-3
n=315 Participants
|
|---|---|---|---|---|---|
|
Bilirubin
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 14 weeks according to protocol.(enrolment to week 12 visit)Change in D-Dimer values from enrolment to week 12 visit for VKA naïve patients while on study drug (week 12 visit-enrolment)
Outcome measures
| Measure |
150 mg od
n=37 Participants
AZD0837 150 mg od
|
300 mg od
n=32 Participants
AZD0837 300 mg od
|
450 mg od
n=35 Participants
AZD0837 450 mg od
|
200 mg bd
n=43 Participants
AZD0837 200 mg bd
|
VKA INR 2-3
n=87 Participants
|
|---|---|---|---|---|---|
|
D-Dimer
|
-46.4 ng/mL
Interval -382.0 to 170.0
|
-76.9 ng/mL
Interval -613.0 to 29.0
|
-45.2 ng/mL
Interval -1817.0 to 230.0
|
-68.0 ng/mL
Interval -1313.0 to 69.0
|
-50.3 ng/mL
Interval -3955.0 to 516.0
|
SECONDARY outcome
Timeframe: 12 weeks according to protocol.(baseline to week 12 visit)Change in Activated partial thromboplastin time (APTT) from baseline to week 12 visit for VKA naïve patients while on study drug (week 12 visit-baseline)
Outcome measures
| Measure |
150 mg od
n=35 Participants
AZD0837 150 mg od
|
300 mg od
n=30 Participants
AZD0837 300 mg od
|
450 mg od
n=34 Participants
AZD0837 450 mg od
|
200 mg bd
n=41 Participants
AZD0837 200 mg bd
|
VKA INR 2-3
|
|---|---|---|---|---|---|
|
Activated Partial Thromboplastin Time (APTT)
|
8.2 sec
Interval -1.0 to 24.0
|
12.3 sec
Interval 2.0 to 110.0
|
17.4 sec
Interval -79.0 to 52.0
|
16.4 sec
Interval 2.0 to 60.0
|
—
|
SECONDARY outcome
Timeframe: 12 weeks according to protocol.(baseline to week 12 visit)Change in Ecarin clotting time (ECT) from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline)
Outcome measures
| Measure |
150 mg od
n=94 Participants
AZD0837 150 mg od
|
300 mg od
n=85 Participants
AZD0837 300 mg od
|
450 mg od
n=85 Participants
AZD0837 450 mg od
|
200 mg bd
n=98 Participants
AZD0837 200 mg bd
|
VKA INR 2-3
|
|---|---|---|---|---|---|
|
Ecarin Clotting Time (ECT)
|
33.5 sec
Interval -1.0 to 86.0
|
53.0 sec
Interval 15.0 to 93.0
|
64.0 sec
Interval 2.0 to 134.0
|
73.5 sec
Interval -1.0 to 166.0
|
—
|
SECONDARY outcome
Timeframe: 12 weeks after baseline according to protocolAssessment made on the week 12 visit
Outcome measures
| Measure |
150 mg od
n=101 Participants
AZD0837 150 mg od
|
300 mg od
n=104 Participants
AZD0837 300 mg od
|
450 mg od
n=107 Participants
AZD0837 450 mg od
|
200 mg bd
n=112 Participants
AZD0837 200 mg bd
|
VKA INR 2-3
|
|---|---|---|---|---|---|
|
Plasma Concentration of AZD0837 (Prodrug)
|
199.8 nmol/L
Interval 10.0 to 2334.0
|
617.5 nmol/L
Interval 10.0 to 5355.0
|
564.5 nmol/L
Interval 10.0 to 14720.0
|
1143.5 nmol/L
Interval 10.0 to 9644.0
|
—
|
SECONDARY outcome
Timeframe: 12 weeks after baseline according to protocolAssessment made on the week 12 visit
Outcome measures
| Measure |
150 mg od
n=101 Participants
AZD0837 150 mg od
|
300 mg od
n=104 Participants
AZD0837 300 mg od
|
450 mg od
n=107 Participants
AZD0837 450 mg od
|
200 mg bd
n=112 Participants
AZD0837 200 mg bd
|
VKA INR 2-3
|
|---|---|---|---|---|---|
|
Plasma Concentration of AR-H067637XX (Active Metabolite)
|
223.8 nmol/L
Interval 10.0 to 503.9
|
373.6 nmol/L
Interval 10.0 to 1074.0
|
454.8 nmol/L
Interval 10.0 to 1490.0
|
600.8 nmol/L
Interval 10.0 to 1523.0
|
—
|
SECONDARY outcome
Timeframe: 36 weeks according to protocolOral clearance of AR-H067637XX in subgroup of patients with genotype TT for gene polymorphism ABCB1 C3435T
Outcome measures
| Measure |
150 mg od
n=34 Participants
AZD0837 150 mg od
|
300 mg od
n=41 Participants
AZD0837 300 mg od
|
450 mg od
n=27 Participants
AZD0837 450 mg od
|
200 mg bd
n=35 Participants
AZD0837 200 mg bd
|
VKA INR 2-3
|
|---|---|---|---|---|---|
|
Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TT
|
39.7 L/h
Interval 22.9 to 79.7
|
42.4 L/h
Interval 13.7 to 699.0
|
36.3 L/h
Interval 21.4 to 62.9
|
35.6 L/h
Interval 19.7 to 67.3
|
—
|
SECONDARY outcome
Timeframe: 36 weeks according to protocolOral clearance of AR-H067637XX in subgroup of patients with genotype TC for gene polymorphism ABCB1 C3435T
Outcome measures
| Measure |
150 mg od
n=73 Participants
AZD0837 150 mg od
|
300 mg od
n=64 Participants
AZD0837 300 mg od
|
450 mg od
n=64 Participants
AZD0837 450 mg od
|
200 mg bd
n=66 Participants
AZD0837 200 mg bd
|
VKA INR 2-3
|
|---|---|---|---|---|---|
|
Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TC
|
39.2 L/h
Interval 19.6 to 130.5
|
39.3 L/h
Interval 17.2 to 138.6
|
37.7 L/h
Interval 18.0 to 79.4
|
40 L/h
Interval 17.4 to 96.7
|
—
|
SECONDARY outcome
Timeframe: 36 weeks according to protocolOral clearance of AR-H067637XX in subgroup of patients with genotype CC for gene polymorphism ABCB1 C3435T
Outcome measures
| Measure |
150 mg od
n=28 Participants
AZD0837 150 mg od
|
300 mg od
n=21 Participants
AZD0837 300 mg od
|
450 mg od
n=31 Participants
AZD0837 450 mg od
|
200 mg bd
n=30 Participants
AZD0837 200 mg bd
|
VKA INR 2-3
|
|---|---|---|---|---|---|
|
Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype CC
|
40.9 L/h
Interval 23.7 to 66.0
|
41.1 L/h
Interval 21.8 to 62.1
|
43.4 L/h
Interval 22.8 to 78.0
|
39.6 L/h
Interval 26.5 to 107.1
|
—
|
Adverse Events
AZD0837 150 mg od
Serious events: 12 serious events
Other events: 46 other events
Deaths: 0 deaths
AZD0837 300 mg od
Serious events: 20 serious events
Other events: 62 other events
Deaths: 0 deaths
AZD0837 450 mg od
Serious events: 31 serious events
Other events: 46 other events
Deaths: 0 deaths
AZD0837 200 mg bd
Serious events: 27 serious events
Other events: 59 other events
Deaths: 0 deaths
VKA INR 2-3
Serious events: 50 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD0837 150 mg od
n=166 participants at risk
|
AZD0837 300 mg od
n=152 participants at risk
|
AZD0837 450 mg od
n=157 participants at risk
|
AZD0837 200 mg bd
n=161 participants at risk
|
VKA INR 2-3
n=319 participants at risk
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic Anaemia
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Cardiac disorders
Cardiac Failure
|
0.60%
1/166
|
2.0%
3/152
|
0.64%
1/157
|
0.62%
1/161
|
1.9%
6/319
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/166
|
1.3%
2/152
|
2.5%
4/157
|
0.00%
0/161
|
1.3%
4/319
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.62%
1/161
|
0.31%
1/319
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/166
|
0.66%
1/152
|
0.00%
0/157
|
0.62%
1/161
|
0.31%
1/319
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.60%
1/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.62%
1/161
|
0.31%
1/319
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.60%
1/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.60%
1/166
|
0.66%
1/152
|
0.64%
1/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.62%
1/161
|
0.00%
0/319
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/166
|
0.66%
1/152
|
0.00%
0/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.00%
0/166
|
0.66%
1/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Eye disorders
Cataract
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.63%
2/319
|
|
Eye disorders
Glaucoma
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Eye disorders
Vitreous Haemorrhage
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/166
|
0.66%
1/152
|
0.00%
0/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/166
|
0.66%
1/152
|
0.00%
0/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Gastrointestinal disorders
Anal Ulcer
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.62%
1/161
|
0.00%
0/319
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.62%
1/161
|
0.00%
0/319
|
|
Gastrointestinal disorders
Periodontal Disease
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Gastrointestinal disorders
Asthenia
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Gastrointestinal disorders
Chest Pain
|
0.00%
0/166
|
0.66%
1/152
|
0.00%
0/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Gastrointestinal disorders
Non-Cardiac Chest Pain
|
0.00%
0/166
|
0.66%
1/152
|
0.00%
0/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Gastrointestinal disorders
Sudden Death
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Hepatobiliary disorders
Chronic Hepatitis
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.62%
1/161
|
0.00%
0/319
|
|
Immune system disorders
Corneal Graft Rejection
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/166
|
0.66%
1/152
|
0.00%
0/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Infections and infestations
Appendicitis
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
1.2%
2/161
|
0.00%
0/319
|
|
Infections and infestations
Abscess Limb
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.62%
1/161
|
0.00%
0/319
|
|
Infections and infestations
Arthritis Bacterial
|
0.60%
1/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Infections and infestations
Erysipelas
|
0.00%
0/166
|
0.66%
1/152
|
0.00%
0/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Infections and infestations
Infective Spondylitis
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.62%
1/161
|
0.00%
0/319
|
|
Infections and infestations
Pyelonephritis Acute
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.62%
1/161
|
0.00%
0/319
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.62%
1/161
|
0.00%
0/319
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.62%
1/161
|
0.00%
0/319
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Injury, poisoning and procedural complications
Haemoglobin Decreased
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
1.2%
2/161
|
0.00%
0/319
|
|
Injury, poisoning and procedural complications
Alanine Aminotransferase Increased
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Injury, poisoning and procedural complications
Blood Glucose Increased
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.60%
1/166
|
0.00%
0/152
|
0.00%
0/157
|
0.62%
1/161
|
0.00%
0/319
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/166
|
0.66%
1/152
|
0.00%
0/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.62%
1/161
|
0.00%
0/319
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.60%
1/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.62%
1/161
|
0.00%
0/319
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Neoplasm
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.62%
1/161
|
0.00%
0/319
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic Adenoma
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Nervous system disorders
Ischaemic Stroke
|
1.2%
2/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Nervous system disorders
Syncope
|
0.00%
0/166
|
0.66%
1/152
|
1.3%
2/157
|
1.2%
2/161
|
0.63%
2/319
|
|
Nervous system disorders
Dizziness
|
0.00%
0/166
|
0.66%
1/152
|
0.00%
0/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Nervous system disorders
Headache
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Nervous system disorders
Syncope Vasovagal
|
0.00%
0/166
|
0.66%
1/152
|
0.00%
0/157
|
0.62%
1/161
|
0.00%
0/319
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.62%
1/161
|
0.31%
1/319
|
|
Nervous system disorders
Vascular Encephalopathy
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Nervous system disorders
Vertebrobasilar Insufficiency
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Psychiatric disorders
Depression
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/166
|
0.66%
1/152
|
0.00%
0/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Vascular disorders
Arterial Stenosis Limb
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Vascular disorders
Axillary Vein Thrombosis
|
0.60%
1/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.62%
1/161
|
0.00%
0/319
|
|
Vascular disorders
Hypertension
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.62%
1/161
|
0.00%
0/319
|
|
Vascular disorders
Hypotension
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/166
|
0.00%
0/152
|
0.64%
1/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Vascular disorders
Peripheral Artery Aneurysm
|
0.00%
0/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.31%
1/319
|
|
Vascular disorders
Peripheral Embolism
|
0.60%
1/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.00%
0/319
|
|
Vascular disorders
Subclavian Vein Thrombosis
|
0.60%
1/166
|
0.00%
0/152
|
0.00%
0/157
|
0.00%
0/161
|
0.00%
0/319
|
Other adverse events
| Measure |
AZD0837 150 mg od
n=166 participants at risk
|
AZD0837 300 mg od
n=152 participants at risk
|
AZD0837 450 mg od
n=157 participants at risk
|
AZD0837 200 mg bd
n=161 participants at risk
|
VKA INR 2-3
n=319 participants at risk
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
8.4%
14/166
|
15.1%
23/152
|
7.6%
12/157
|
10.6%
17/161
|
4.7%
15/319
|
|
Gastrointestinal disorders
NAUSEA
|
3.6%
6/166
|
5.3%
8/152
|
5.1%
8/157
|
5.6%
9/161
|
4.7%
15/319
|
|
Gastrointestinal disorders
FLATULENCE
|
6.0%
10/166
|
7.2%
11/152
|
3.8%
6/157
|
6.2%
10/161
|
0.31%
1/319
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
1.2%
2/166
|
0.66%
1/152
|
5.1%
8/157
|
1.2%
2/161
|
0.94%
3/319
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.0%
10/166
|
6.6%
10/152
|
3.2%
5/157
|
6.2%
10/161
|
6.3%
20/319
|
|
Nervous system disorders
DIZZINESS
|
2.4%
4/166
|
5.9%
9/152
|
4.5%
7/157
|
6.8%
11/161
|
4.1%
13/319
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60