Trial Outcomes & Findings for Long-term Safety in Atrial Fibrillation Patients (NCT NCT00645853)
NCT ID: NCT00645853
Last Updated: 2012-03-23
Results Overview
Participants
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
523 participants
Primary outcome timeframe
154-711 days on treatment
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 25 October 2007 to 20 May 2008 at medical clinics in Europe.
All participants had previously participated in the Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation (NCT00684307) study
Participant milestones
| Measure |
AZD0837
Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
|
VKA, INR 2-3
Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
|
|---|---|---|
|
Overall Study
STARTED
|
288
|
235
|
|
Overall Study
No of Patients After Dose Switch
|
209
|
188
|
|
Overall Study
Discontinued Patient No Due to Closure
|
196
|
178
|
|
Overall Study
AZ Study Closure in Hungary
|
60
|
40
|
|
Overall Study
COMPLETED
|
196
|
178
|
|
Overall Study
NOT COMPLETED
|
92
|
57
|
Reasons for withdrawal
| Measure |
AZD0837
Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
|
VKA, INR 2-3
Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
|
|---|---|---|
|
Overall Study
Adverse Event
|
18
|
7
|
|
Overall Study
AZ study closure in Hungary
|
60
|
40
|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Discontinuation criteria
|
2
|
2
|
|
Overall Study
recall of ICF, planned operation, death
|
7
|
4
|
Baseline Characteristics
Long-term Safety in Atrial Fibrillation Patients
Baseline characteristics by cohort
| Measure |
AZD0837
n=288 Participants
Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
|
VKA, INR 2-3
n=235 Participants
Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
|
Total
n=523 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
69.9 Years
n=5 Participants
|
68.0 Years
n=7 Participants
|
68.95 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
198 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
360 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 154-711 days on treatmentParticipants
Outcome measures
| Measure |
AZD0837
n=288 Participants
Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
|
VKA, INR 2-3
n=235 Participants
Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
|
|---|---|---|
|
Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period
|
55 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: From baseline to Follow upULN=Upper limit of Normal
Outcome measures
| Measure |
AZD0837
n=288 Participants
Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
|
VKA, INR 2-3
n=235 Participants
Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
|
|---|---|---|
|
Alanine Transaminase (ALAT): Number of Patients With ALAT>=3xULN, Post Baseline
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From baseline to Follow upOutcome measures
| Measure |
AZD0837
n=288 Participants
Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
|
VKA, INR 2-3
n=235 Participants
Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
|
|---|---|---|
|
Bilirubin: Number of Patients With Bilirubin>=2xULN, Post Baseline
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and End of treatmentOutcome measures
| Measure |
AZD0837
n=288 Participants
Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
|
VKA, INR 2-3
n=235 Participants
Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
|
|---|---|---|
|
Creatinine: Absolute Change From Baseline, at End of Treatment
|
3.70 µmol/L
Full Range -67.0 • Interval -67.0 to 120.0
|
-1.17 µmol/L
Full Range -56.0 • Interval -56.0 to 116.0
|
SECONDARY outcome
Timeframe: End of treatmentPopulation: Only patients who switched to one common dose, 300 mg od, are included in the AZD0837 analysis
Median (Lower Quartile-Upper Quartile ), ng/mL
Outcome measures
| Measure |
AZD0837
n=193 Participants
Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
|
VKA, INR 2-3
n=232 Participants
Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
|
|---|---|---|
|
D-dimer:Median and Quartile Range at End of Treatment
|
68.9 ng/mL
Interval 43.3 to 128.4
|
54.9 ng/mL
Interval 31.9 to 99.0
|
SECONDARY outcome
Timeframe: Baseline and End of treatmentPopulation: Only patients who switched to one common dose, 300 mg od, are included in the AZD0837 analysis
Median Full range, Seconds
Outcome measures
| Measure |
AZD0837
n=173 Participants
Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
|
VKA, INR 2-3
Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
|
|---|---|---|
|
Activated Partial Thromboplastin Time (APTT): Absolute Change From Baseline to End of Treatment
|
12.9 sec
Interval -62.0 to 43.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and End of TreatmentPopulation: Only patients who switched to one dose, 300 mg od, are included in the AZD0837 analysis
Outcome measures
| Measure |
AZD0837
n=129 Participants
Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
|
VKA, INR 2-3
Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
|
|---|---|---|
|
Electroconvulsive Therapy (ECT): Absolute Change From Baseline to End of Treatment
|
49.0 sec
Interval -5.0 to 96.0
|
—
|
SECONDARY outcome
Timeframe: End of treatmentPopulation: Only patients who switched to one dose, 300 mg od, are included in the AZD0837 analysis
Outcome measures
| Measure |
AZD0837
n=195 Participants
Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
|
VKA, INR 2-3
Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
|
|---|---|---|
|
AZD0837: Plasma Concentration of AZD0837 at End of Treatment
|
675 nmol/L
Interval 10.0 to 4090.0
|
—
|
SECONDARY outcome
Timeframe: 154-711 days on treatmentPopulation: Only patients who switched to one dose, 300 mg od, are included in the AZD0837 analysis
Outcome measures
| Measure |
AZD0837
n=195 Participants
Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
|
VKA, INR 2-3
Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
|
|---|---|---|
|
AR-H067637XX, the Active Major Metabolite of AD0837: Plasma Concentration of AR-H067637XX, at End of Treatment
|
341 nmol/L
Interval 10.0 to 929.0
|
—
|
Adverse Events
AZD0837
Serious events: 73 serious events
Other events: 125 other events
Deaths: 0 deaths
VKA INR 2-3
Serious events: 61 serious events
Other events: 106 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD0837
n=288 participants at risk
Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od and then switching to one general common dose, 300 mg od
|
VKA INR 2-3
n=235 participants at risk
Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Cardiac disorders
Cardiac Failure
|
2.4%
7/288 • 154-711 days on treatment
|
2.6%
6/235 • 154-711 days on treatment
|
|
Cardiac disorders
Atrial Fibrillation
|
1.4%
4/288 • 154-711 days on treatment
|
1.7%
4/235 • 154-711 days on treatment
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/288 • 154-711 days on treatment
|
1.3%
3/235 • 154-711 days on treatment
|
|
Cardiac disorders
Bradycardia
|
1.0%
3/288 • 154-711 days on treatment
|
0.85%
2/235 • 154-711 days on treatment
|
|
Cardiac disorders
Angina Pectoris
|
0.69%
2/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.69%
2/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Cardiac disorders
Chordae Tendinae Rupture
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Cardiac disorders
Heart Valve Incompetence
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Cardiac disorders
Palpitations
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Cardiac disorders
Tachycardia
|
0.35%
1/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Endocrine disorders
Hyperthyroidism
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Eye disorders
Cataract
|
0.35%
1/288 • 154-711 days on treatment
|
0.85%
2/235 • 154-711 days on treatment
|
|
Eye disorders
Eye Haemorrhage
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Eye disorders
Glaucoma
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Eye disorders
Retinal Artery Embolism
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/288 • 154-711 days on treatment
|
1.3%
3/235 • 154-711 days on treatment
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/288 • 154-711 days on treatment
|
0.85%
2/235 • 154-711 days on treatment
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Gastrointestinal disorders
Anal Haemorrhage
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Gastrointestinal disorders
Anal Ulcer
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.35%
1/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Gastrointestinal disorders
Nausea
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Gastrointestinal disorders
Periodontal Disease
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
General disorders
Death
|
0.69%
2/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/288 • 154-711 days on treatment
|
0.85%
2/235 • 154-711 days on treatment
|
|
General disorders
Asthenia
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Hepatobiliary disorders
Jaundice Cholestatic
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Immune system disorders
Corneal Graft Rejection
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Infections and infestations
Bronchitis
|
0.69%
2/288 • 154-711 days on treatment
|
1.3%
3/235 • 154-711 days on treatment
|
|
Infections and infestations
Erysipelas
|
1.0%
3/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Infections and infestations
Pneumonia
|
1.0%
3/288 • 154-711 days on treatment
|
1.3%
3/235 • 154-711 days on treatment
|
|
Infections and infestations
Abscess Limb
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Infections and infestations
Endocarditis
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Infections and infestations
Gastroenteritis
|
0.35%
1/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Infections and infestations
Intervertebral Discitis
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Infections and infestations
Laryngitis
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Infections and infestations
Pyelonephritis
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Infections and infestations
Respiratory Tract Infection
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Infections and infestations
Sinusitis
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Infections and infestations
Urosepsis
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Injury, poisoning and procedural complications
Foreign Body Trauma
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Investigations
Alanine Aminotransferase Increased
|
0.69%
2/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Investigations
Haemoglobin Decreased
|
0.35%
1/288 • 154-711 days on treatment
|
0.85%
2/235 • 154-711 days on treatment
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.69%
2/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.35%
1/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/288 • 154-711 days on treatment
|
0.85%
2/235 • 154-711 days on treatment
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.69%
2/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.35%
1/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Musculoskeletal and connective tissue disorders
Inguinal Mass
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle Atrophy
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
1.0%
3/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Adenoma
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Metastatic
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Central Nervous System
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Nervous system disorders
Syncope
|
1.0%
3/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Nervous system disorders
Headache
|
0.00%
0/288 • 154-711 days on treatment
|
0.85%
2/235 • 154-711 days on treatment
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.35%
1/288 • 154-711 days on treatment
|
0.85%
2/235 • 154-711 days on treatment
|
|
Nervous system disorders
Cerebral Artery Embolism
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.35%
1/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Nervous system disorders
Dizziness
|
0.35%
1/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Nervous system disorders
Encephalitis
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Nervous system disorders
Epilepsy
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Nervous system disorders
Ischaemic Stroke
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Nervous system disorders
Status Epilepticus
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Nervous system disorders
Vascular Encephalopathy
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Nervous system disorders
Vertebrobasilar Insufficiency
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Psychiatric disorders
Delusional Disorder, Persecutory Type
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Psychiatric disorders
Dysthymic Disorder
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Renal and urinary disorders
Haematuria
|
0.69%
2/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Renal and urinary disorders
Dysuria
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Renal and urinary disorders
Renal Failure
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Renal and urinary disorders
Urinary Bladder Haemorrhage
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Reproductive system and breast disorders
Postmenopausal Haemorrhage
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.69%
2/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.35%
1/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
Vascular disorders
Arterial Occlusive Disease
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Vascular disorders
Arterial Stenosis Limb
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Vascular disorders
Hypertension
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Vascular disorders
Orthostatic Hypotension
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Vascular disorders
Peripheral Artery Aneurysm
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Vascular disorders
Peripheral Embolism
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Vascular disorders
Subclavian Vein Thrombosis
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
|
Vascular disorders
800003Varicose Vein
|
0.35%
1/288 • 154-711 days on treatment
|
0.00%
0/235 • 154-711 days on treatment
|
Other adverse events
| Measure |
AZD0837
n=288 participants at risk
Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od and then switching to one general common dose, 300 mg od
|
VKA INR 2-3
n=235 participants at risk
Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
12.8%
37/288 • 154-711 days on treatment
|
7.7%
18/235 • 154-711 days on treatment
|
|
Gastrointestinal disorders
Flatulence
|
6.9%
20/288 • 154-711 days on treatment
|
0.43%
1/235 • 154-711 days on treatment
|
|
General disorders
Oedema Peripheral
|
8.7%
25/288 • 154-711 days on treatment
|
8.5%
20/235 • 154-711 days on treatment
|
|
General disorders
Fatigue
|
6.6%
19/288 • 154-711 days on treatment
|
3.8%
9/235 • 154-711 days on treatment
|
|
Infections and infestations
Nasopharyngitis
|
12.2%
35/288 • 154-711 days on treatment
|
12.8%
30/235 • 154-711 days on treatment
|
|
Infections and infestations
Bronchitis
|
4.9%
14/288 • 154-711 days on treatment
|
7.7%
18/235 • 154-711 days on treatment
|
|
Infections and infestations
Urinary Tract Infection
|
4.5%
13/288 • 154-711 days on treatment
|
6.4%
15/235 • 154-711 days on treatment
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
4/288 • 154-711 days on treatment
|
5.1%
12/235 • 154-711 days on treatment
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.2%
15/288 • 154-711 days on treatment
|
5.1%
12/235 • 154-711 days on treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
9/288 • 154-711 days on treatment
|
5.5%
13/235 • 154-711 days on treatment
|
|
Nervous system disorders
Dizziness
|
8.3%
24/288 • 154-711 days on treatment
|
7.2%
17/235 • 154-711 days on treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60