Trial Outcomes & Findings for JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme (NCT NCT00311402)
NCT ID: NCT00311402
Last Updated: 2014-02-14
Results Overview
All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1295 participants
Primary outcome timeframe
Up to 124 weeks
Results posted on
2014-02-14
Participant Flow
Patient recruitment initiated from June 2006 and completed in December 2007.
Participant milestones
| Measure |
Aggrenox Capsule
Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
|
Acetylsalicylic Acid (ASA) 81 mg Tablet
ASA 81 mg, 1 tablet once daily
|
|---|---|---|
|
Overall Study
STARTED
|
655
|
639
|
|
Overall Study
COMPLETED
|
445
|
462
|
|
Overall Study
NOT COMPLETED
|
210
|
177
|
Reasons for withdrawal
| Measure |
Aggrenox Capsule
Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
|
Acetylsalicylic Acid (ASA) 81 mg Tablet
ASA 81 mg, 1 tablet once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
118
|
105
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
17
|
18
|
|
Overall Study
Lack of Efficacy
|
58
|
42
|
|
Overall Study
Protocol Violation
|
7
|
6
|
|
Overall Study
IRB's rejection etc.
|
10
|
3
|
Baseline Characteristics
JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme
Baseline characteristics by cohort
| Measure |
Aggrenox Capsule
n=655 Participants
Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
|
Acetylsalicylic Acid (ASA) 81 mg Tablet
n=639 Participants
ASA 81 mg, 1 tablet once daily
|
Total
n=1294 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 8.1 • n=99 Participants
|
66.0 years
STANDARD_DEVIATION 8.6 • n=107 Participants
|
66.1 years
STANDARD_DEVIATION 8.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
183 Participants
n=99 Participants
|
186 Participants
n=107 Participants
|
369 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
472 Participants
n=99 Participants
|
453 Participants
n=107 Participants
|
925 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 124 weeksPopulation: All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.
All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
Outcome measures
| Measure |
Aggrenox Capsule
n=652 Participants
Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
|
Acetylsalicylic Acid (ASA) 81 mg Tablet
n=639 Participants
ASA 81 mg, 1 tablet once daily
|
|---|---|---|
|
Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal)
|
45 patients
|
32 patients
|
SECONDARY outcome
Timeframe: Up to 124 weeksPopulation: All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.
All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
Outcome measures
| Measure |
Aggrenox Capsule
n=652 Participants
Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
|
Acetylsalicylic Acid (ASA) 81 mg Tablet
n=639 Participants
ASA 81 mg, 1 tablet once daily
|
|---|---|---|
|
Number of Patients With Brain (Cerebral) Haemorrhage
|
12 patients
|
7 patients
|
SECONDARY outcome
Timeframe: Up to 124 weeksPopulation: All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.
All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
Outcome measures
| Measure |
Aggrenox Capsule
n=652 Participants
Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
|
Acetylsalicylic Acid (ASA) 81 mg Tablet
n=639 Participants
ASA 81 mg, 1 tablet once daily
|
|---|---|---|
|
Number of Patients With Subarachnoid Haemorrhage
|
0 patients
|
1 patients
|
SECONDARY outcome
Timeframe: Up to 124 weeksPopulation: All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.
All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
Outcome measures
| Measure |
Aggrenox Capsule
n=652 Participants
Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
|
Acetylsalicylic Acid (ASA) 81 mg Tablet
n=639 Participants
ASA 81 mg, 1 tablet once daily
|
|---|---|---|
|
Number of Patients With Transient Ischemic Attack (TIA)
|
3 patients
|
3 patients
|
SECONDARY outcome
Timeframe: Up to 124 weeksPopulation: All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.
ACS contains acute myocardial infarction (MI), unstable angina and sudden cardiac death. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
Outcome measures
| Measure |
Aggrenox Capsule
n=652 Participants
Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
|
Acetylsalicylic Acid (ASA) 81 mg Tablet
n=639 Participants
ASA 81 mg, 1 tablet once daily
|
|---|---|---|
|
Number of Patients With Acute Coronary Syndrome (ACS)
|
9 patients
|
16 patients
|
SECONDARY outcome
Timeframe: Up to 124 weeksPopulation: All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.
This endpoints were defined as pulmonary embolism, retinal vascular disorder, deep vein thrombosis, peripheral artery obstruction and vascular intervention. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
Outcome measures
| Measure |
Aggrenox Capsule
n=652 Participants
Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
|
Acetylsalicylic Acid (ASA) 81 mg Tablet
n=639 Participants
ASA 81 mg, 1 tablet once daily
|
|---|---|---|
|
Number of Patients With Other Vascular Events
|
11 patients
|
6 patients
|
SECONDARY outcome
Timeframe: Up to 124 weeksPopulation: All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.
This is a composite endpoint of cerebral infarction, transient ischemic attack (TIA), acute myocardial infarction (MI), unstable angina and sudden death attributable to thromboembolism. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
Outcome measures
| Measure |
Aggrenox Capsule
n=652 Participants
Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
|
Acetylsalicylic Acid (ASA) 81 mg Tablet
n=639 Participants
ASA 81 mg, 1 tablet once daily
|
|---|---|---|
|
Number of Patients With Ischemic Vascular Event Composite Endpoint
|
57 patients
|
51 patients
|
POST_HOC outcome
Timeframe: Up to 124 weeksPopulation: All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.
This is a composite endpoint of cerebral infarction, brain (cerebral) hemorrhage and subarachnoid haemorrhage. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
Outcome measures
| Measure |
Aggrenox Capsule
n=652 Participants
Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
|
Acetylsalicylic Acid (ASA) 81 mg Tablet
n=639 Participants
ASA 81 mg, 1 tablet once daily
|
|---|---|---|
|
Number of Patients With Stroke
|
57 patients
|
39 patients
|
POST_HOC outcome
Timeframe: Up to 124 weeksPopulation: All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.
All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
Outcome measures
| Measure |
Aggrenox Capsule
n=652 Participants
Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
|
Acetylsalicylic Acid (ASA) 81 mg Tablet
n=639 Participants
ASA 81 mg, 1 tablet once daily
|
|---|---|---|
|
Number of Patients With Intracranial Haemorrhage
|
13 patients
|
13 patients
|
POST_HOC outcome
Timeframe: Up to 124 weeksPopulation: All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.
This is a composite endpoint of cerebral infarction, brain (cerebral) hemorrhage, subarachnoid haemorrhage and major bleeding. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
Outcome measures
| Measure |
Aggrenox Capsule
n=652 Participants
Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
|
Acetylsalicylic Acid (ASA) 81 mg Tablet
n=639 Participants
ASA 81 mg, 1 tablet once daily
|
|---|---|---|
|
Number of Patients With Composite Endpoint of Stroke or Major Bleeding
|
71 patients
|
55 patients
|
Adverse Events
Aggrenox Capsule
Serious events: 178 serious events
Other events: 634 other events
Deaths: 0 deaths
Acetylsalicylic Acid (ASA) 81 mg Tablet
Serious events: 167 serious events
Other events: 604 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aggrenox Capsule
n=655 participants at risk
Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
|
Acetylsalicylic Acid (ASA) 81 mg Tablet
n=639 participants at risk
ASA 81 mg, 1 tablet once daily
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.31%
2/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.47%
3/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Infections and infestations
Urinary tract infection
|
0.31%
2/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Infections and infestations
Bronchopulmonary aspergillosis allergic
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Infections and infestations
Cellulitis
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Infections and infestations
Gangrene
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Infections and infestations
Pleurisy viral
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.61%
4/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.63%
4/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.46%
3/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.63%
4/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.46%
3/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.46%
3/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.31%
2/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.31%
2/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.31%
2/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.31%
2/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Endocrine disorders
Hyperadrenalism
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.46%
3/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.31%
2/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.31%
2/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.31%
2/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Metabolism and nutrition disorders
Anorexia
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Psychiatric disorders
Depression
|
0.31%
2/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Psychiatric disorders
Completed suicide
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Nervous system disorders
Cerebral infarction
|
7.0%
46/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
5.0%
32/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.76%
5/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.31%
2/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.61%
4/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Nervous system disorders
Dizziness
|
0.31%
2/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.47%
3/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.31%
2/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.47%
3/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Nervous system disorders
Epilepsy
|
0.31%
2/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.31%
2/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Nervous system disorders
Transient ischaemic attack
|
0.31%
2/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Nervous system disorders
Basilar migraine
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Nervous system disorders
Cerebellar infarction
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Nervous system disorders
Cerebrovascular accident
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Nervous system disorders
Mental impairment
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Nervous system disorders
Putamen haemorrhage
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Eye disorders
Cataract
|
0.46%
3/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.94%
6/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Eye disorders
Maculopathy
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.31%
2/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Eye disorders
Eyelid ptosis
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Eye disorders
Retinal artery occlusion
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Eye disorders
Retinal detachment
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Eye disorders
Retinal vein occlusion
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Eye disorders
Vitreous haemorrhage
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Ear and labyrinth disorders
Vertigo
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.31%
2/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.31%
2/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Ear and labyrinth disorders
Auricular perichondritis
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Ear and labyrinth disorders
Vertigo labyrinthine
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Cardiac disorders
Angina unstable
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.94%
6/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Cardiac disorders
Angina pectoris
|
0.76%
5/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.63%
4/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Cardiac disorders
Myocardial infarction
|
0.31%
2/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Cardiac disorders
Acute myocardial infarction
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Cardiac disorders
Right ventricular failure
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Vascular disorders
Thrombophlebitis
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Colonic polyp
|
1.7%
11/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
1.3%
8/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.63%
4/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.46%
3/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.31%
2/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.31%
2/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.47%
3/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.31%
2/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Oesophageal rupture
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Oesophagitis haemorrhagic
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.31%
2/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Renal and urinary disorders
Calculus bladder
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Renal and urinary disorders
Renal failure chronic
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Renal and urinary disorders
Renal impairment
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.31%
2/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Reproductive system and breast disorders
Pelvic haemorrhage
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
General disorders
Sudden death
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.63%
4/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
General disorders
Multi-organ failure
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.31%
2/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
General disorders
Chest pain
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
General disorders
Implant site inflammation
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
General disorders
Mass
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
General disorders
Oedema due to renal disease
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
General disorders
Pain
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.63%
4/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.63%
4/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.47%
3/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.47%
3/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.47%
3/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Cerebral haemorrhage traumatic
|
0.31%
2/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.31%
2/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.31%
2/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.31%
2/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.31%
2/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Blast injury
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Diffuse axonal injury
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Fat embolism
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Pubic rami fracture
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.15%
1/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.00%
0/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
0.16%
1/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
Other adverse events
| Measure |
Aggrenox Capsule
n=655 participants at risk
Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
|
Acetylsalicylic Acid (ASA) 81 mg Tablet
n=639 participants at risk
ASA 81 mg, 1 tablet once daily
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
42.9%
281/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
40.8%
261/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Nervous system disorders
Headache
|
44.7%
293/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
29.3%
187/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Nervous system disorders
Dizziness
|
8.9%
58/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
8.6%
55/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Vascular disorders
Hypertension
|
5.6%
37/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
8.3%
53/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Diarrhoea
|
11.9%
78/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
6.6%
42/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Constipation
|
5.2%
34/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
9.4%
60/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Gastrointestinal disorders
Nausea
|
6.1%
40/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
6.6%
42/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.6%
30/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
6.6%
42/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.9%
58/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
9.2%
59/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.2%
34/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
6.1%
39/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Fall
|
8.9%
58/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
10.8%
69/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Contusion
|
7.0%
46/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
9.4%
60/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
7.0%
46/655 • From day of first drug dose until 6 days after last dose, up to 874 days
|
6.7%
43/639 • From day of first drug dose until 6 days after last dose, up to 874 days
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract
- Publication restrictions are in place
Restriction type: OTHER