Trial Outcomes & Findings for AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke (NCT NCT03192215)
NCT ID: NCT03192215
Last Updated: 2025-04-09
Results Overview
Participants were monitored for up to 5 years of study participation. This is the number of participants who had recurrent stroke of any type (ischemic, hemorrhagic, or of unclear type).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1015 participants
Primary outcome timeframe
Up to 5 years of study participation.
Results posted on
2025-04-09
Participant Flow
There were 37,443 potential participants screened, 2,730 were consented by 174 sites into the trial to undergo further criteria review and determine eligibility for randomization by criterion. Once a subject reached eligibility criteria for at least one of the three trial markers, they were approached for randomization. In the end, the study randomized 1,015 subjects at 141 sites (507 in apixaban arm \& 508 in aspirin arm).
2,730 subjects were consented, then 3 biomarkers were obtained and reviewed for randomization eligibility. 1,015 out of 2,730 were eligible and randomized into the study.
Participant milestones
| Measure |
Active Agent: Apixaban
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Apixaban
Apixaban: 5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose) and aspirin placebo once daily.
|
Active Control: Aspirin
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Aspirin
Aspirin: Aspirin 81 mg by mouth once daily and apixaban placebo twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
507
|
508
|
|
Overall Study
COMPLETED
|
416
|
421
|
|
Overall Study
NOT COMPLETED
|
91
|
87
|
Reasons for withdrawal
| Measure |
Active Agent: Apixaban
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Apixaban
Apixaban: 5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose) and aspirin placebo once daily.
|
Active Control: Aspirin
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Aspirin
Aspirin: Aspirin 81 mg by mouth once daily and apixaban placebo twice daily.
|
|---|---|---|
|
Overall Study
Death
|
28
|
23
|
|
Overall Study
Lost to Follow-up
|
10
|
15
|
|
Overall Study
Withdrawal by Subject
|
49
|
48
|
|
Overall Study
Other as reported in analysis
|
4
|
1
|
Baseline Characteristics
Not all randomized subjects had weight measurement entered.
Baseline characteristics by cohort
| Measure |
Active Agent: Apixaban
n=507 Participants
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Apixaban
Apixaban: 5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose) and an aspirin placebo once daily.
|
Active Control: Aspirin
n=508 Participants
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Aspirin
Aspirin: Aspirin 81 mg by mouth once daily and an apixaban placebo twice daily.
|
Total
n=1015 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
White
|
381 Participants
n=507 Participants
|
379 Participants
n=508 Participants
|
760 Participants
n=1015 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=507 Participants
|
1 Participants
n=508 Participants
|
3 Participants
n=1015 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=507 Participants
|
8 Participants
n=508 Participants
|
14 Participants
n=1015 Participants
|
|
Region of Enrollment
Canada
|
16 participants
n=507 Participants
|
16 participants
n=508 Participants
|
32 participants
n=1015 Participants
|
|
Region of Enrollment
United States
|
491 participants
n=507 Participants
|
492 participants
n=508 Participants
|
983 participants
n=1015 Participants
|
|
Weight (kg)
|
85.1 kg
STANDARD_DEVIATION 20.1 • n=507 Participants • Not all randomized subjects had weight measurement entered.
|
84.5 kg
STANDARD_DEVIATION 20.2 • n=506 Participants • Not all randomized subjects had weight measurement entered.
|
84.8 kg
STANDARD_DEVIATION 20.2 • n=1013 Participants • Not all randomized subjects had weight measurement entered.
|
|
CHA2DS2-VASc Score
|
4.7 points in a score system
STANDARD_DEVIATION 1.3 • n=507 Participants
|
4.7 points in a score system
STANDARD_DEVIATION 1.3 • n=508 Participants
|
4.7 points in a score system
STANDARD_DEVIATION 1.3 • n=1015 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=507 Participants
|
0 Participants
n=508 Participants
|
0 Participants
n=1015 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
202 Participants
n=507 Participants
|
179 Participants
n=508 Participants
|
381 Participants
n=1015 Participants
|
|
Age, Categorical
>=65 years
|
305 Participants
n=507 Participants
|
329 Participants
n=508 Participants
|
634 Participants
n=1015 Participants
|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 10.8 • n=507 Participants
|
68.2 years
STANDARD_DEVIATION 11.0 • n=508 Participants
|
68.0 years
STANDARD_DEVIATION 10.9 • n=1015 Participants
|
|
Sex: Female, Male
Female
|
272 Participants
n=507 Participants
|
279 Participants
n=508 Participants
|
551 Participants
n=1015 Participants
|
|
Sex: Female, Male
Male
|
235 Participants
n=507 Participants
|
229 Participants
n=508 Participants
|
464 Participants
n=1015 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
43 Participants
n=505 Participants • There were some participants that did not provide this information.
|
39 Participants
n=505 Participants • There were some participants that did not provide this information.
|
82 Participants
n=1010 Participants • There were some participants that did not provide this information.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
462 Participants
n=505 Participants • There were some participants that did not provide this information.
|
466 Participants
n=505 Participants • There were some participants that did not provide this information.
|
928 Participants
n=1010 Participants • There were some participants that did not provide this information.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=505 Participants • There were some participants that did not provide this information.
|
0 Participants
n=505 Participants • There were some participants that did not provide this information.
|
0 Participants
n=1010 Participants • There were some participants that did not provide this information.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=507 Participants
|
3 Participants
n=508 Participants
|
4 Participants
n=1015 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=507 Participants
|
10 Participants
n=508 Participants
|
17 Participants
n=1015 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=507 Participants
|
0 Participants
n=508 Participants
|
3 Participants
n=1015 Participants
|
|
Race (NIH/OMB)
Black or African American
|
107 Participants
n=507 Participants
|
107 Participants
n=508 Participants
|
214 Participants
n=1015 Participants
|
|
NIH Stroke Scale
|
1 score on a scale
n=504 Participants • The admission NIHSS was not entered on all randomized subjects.
|
1 score on a scale
n=506 Participants • The admission NIHSS was not entered on all randomized subjects.
|
1 score on a scale
n=1010 Participants • The admission NIHSS was not entered on all randomized subjects.
|
|
Atrial Cardiopathy Biomarker - NTproBNP (pg/mL)
|
288 pg/mL
n=502 Participants • Subjects were eligible for randomization based on at least one biomarker and some did not have all of the three biomarkers measured/entered.
|
318 pg/mL
n=496 Participants • Subjects were eligible for randomization based on at least one biomarker and some did not have all of the three biomarkers measured/entered.
|
303 pg/mL
n=998 Participants • Subjects were eligible for randomization based on at least one biomarker and some did not have all of the three biomarkers measured/entered.
|
|
Atrial Cardiopathy Biomarker - P-wave terminal force in lead V1 (µV*ms)
|
4,716 µV*ms
STANDARD_DEVIATION 2,515 • n=501 Participants • Subjects were eligible for randomization based on at least one biomarker and some did not have all of the three biomarkers measured/entered.
|
4,766 µV*ms
STANDARD_DEVIATION 2,920 • n=503 Participants • Subjects were eligible for randomization based on at least one biomarker and some did not have all of the three biomarkers measured/entered.
|
4,741 µV*ms
STANDARD_DEVIATION 2,724 • n=1004 Participants • Subjects were eligible for randomization based on at least one biomarker and some did not have all of the three biomarkers measured/entered.
|
|
Atrial Cardiopathy Biomarker - Left atrial diameter index (cm/m2; site reported)
|
1.9 cm/m2
STANDARD_DEVIATION 0.5 • n=406 Participants • Subjects were eligible for randomization based on at least one biomarker and some did not have all of the three biomarkers measured/entered.
|
1.9 cm/m2
STANDARD_DEVIATION 0.5 • n=412 Participants • Subjects were eligible for randomization based on at least one biomarker and some did not have all of the three biomarkers measured/entered.
|
1.9 cm/m2
STANDARD_DEVIATION 0.5 • n=818 Participants • Subjects were eligible for randomization based on at least one biomarker and some did not have all of the three biomarkers measured/entered.
|
|
Medical Comorbidities - Hypertension
|
396 Participants
n=507 Participants
|
388 Participants
n=508 Participants
|
784 Participants
n=1015 Participants
|
|
Medical Comorbidities - Prior or Current Tobacco Use
|
230 Participants
n=507 Participants
|
200 Participants
n=508 Participants
|
430 Participants
n=1015 Participants
|
|
Medical Comorbidities - Diabetes mellitus
|
156 Participants
n=507 Participants
|
159 Participants
n=508 Participants
|
315 Participants
n=1015 Participants
|
|
Medical Comorbidities - Prior stroke or TIA
|
97 Participants
n=507 Participants
|
100 Participants
n=508 Participants
|
197 Participants
n=1015 Participants
|
|
Medical Comorbidities - Ischemic Heart Disease
|
58 Participants
n=507 Participants
|
46 Participants
n=508 Participants
|
104 Participants
n=1015 Participants
|
|
Medical Comorbidities - Heart Failure
|
36 Participants
n=507 Participants
|
35 Participants
n=508 Participants
|
71 Participants
n=1015 Participants
|
|
Medical Comorbidities - Peripheral Arterial Disease
|
12 Participants
n=507 Participants
|
7 Participants
n=508 Participants
|
19 Participants
n=1015 Participants
|
|
Days from index stroke to randomization
|
48 days
n=507 Participants
|
53 days
n=508 Participants
|
50 days
n=1015 Participants
|
PRIMARY outcome
Timeframe: Up to 5 years of study participation.Participants were monitored for up to 5 years of study participation. This is the number of participants who had recurrent stroke of any type (ischemic, hemorrhagic, or of unclear type).
Outcome measures
| Measure |
Active Agent: Apixaban
n=507 Participants
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Apixaban
Apixaban: 5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose).
|
Active Control: Aspirin
n=508 Participants
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Aspirin
Aspirin: Aspirin 81 mg by mouth once daily.
|
|---|---|---|
|
Number of Participants With Recurrent Stroke of Any Type
|
40 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Up to 5 years of study participation.Secondary efficacy outcome A. Participants were monitored for up to 5 years. This is the number of participants who had recurrent ischemic stroke or systemic embolism during the time of observation.
Outcome measures
| Measure |
Active Agent: Apixaban
n=507 Participants
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Apixaban
Apixaban: 5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose).
|
Active Control: Aspirin
n=508 Participants
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Aspirin
Aspirin: Aspirin 81 mg by mouth once daily.
|
|---|---|---|
|
Number of Participants With Recurrent Ischemic Stroke or Systemic Embolism
|
37 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Up to 5 years of study participation.Secondary efficacy outcome B. Participants were monitored for up to 5 years. This is the number of participants who had recurrent stroke of any type or death from any cause during the observation time.
Outcome measures
| Measure |
Active Agent: Apixaban
n=507 Participants
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Apixaban
Apixaban: 5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose).
|
Active Control: Aspirin
n=508 Participants
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Aspirin
Aspirin: Aspirin 81 mg by mouth once daily.
|
|---|---|---|
|
Number of Participants With Recurrent Stroke of Any Type or Death From Any Cause
|
67 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: Through 30 days after permanent discontinuation of the study drug, a duration of up to 5 years for each participant.Population: The safety sample includes all participants who are randomized and receive at least one dose of study medication. The safety sample will include all safety outcomes from randomization until 30 days after permanent discontinuation of study drug.
Primary safety outcome A. This is the number of participants who had symptomatic intracranial hemorrhage from any cause during the time of observation. Symptomatic intracranial hemorrhage includes symptomatic hemorrhagic transformation of ischemic stroke, which required new symptoms or signs adjudicated as being due to the hemorrhagic transformation or a patient whose initial imaging was judged to include hemorrhagic transformation of an ischemic stroke.
Outcome measures
| Measure |
Active Agent: Apixaban
n=482 Participants
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Apixaban
Apixaban: 5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose).
|
Active Control: Aspirin
n=493 Participants
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Aspirin
Aspirin: Aspirin 81 mg by mouth once daily.
|
|---|---|---|
|
Number of Participants With Symptomatic Intracranial Hemorrhage (Including Symptomatic Hemorrhagic Transformation of an Ischemic Stroke)
|
0 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Through 30 days after permanent discontinuation of the study drug, a duration of up to 5 years for each participant.Population: The safety sample includes all participants who are randomized and receive at least one dose of study medication. The safety sample will include all safety outcomes from randomization until 30 days after permanent discontinuation of study drug.
This is the number of participants who had major hemorrhage other than intracranial hemorrhage.
Outcome measures
| Measure |
Active Agent: Apixaban
n=482 Participants
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Apixaban
Apixaban: 5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose).
|
Active Control: Aspirin
n=493 Participants
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Aspirin
Aspirin: Aspirin 81 mg by mouth once daily.
|
|---|---|---|
|
Number of Participants With Major Hemorrhage Other Than Intracranial Hemorrhage.
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Through 30 days after permanent discontinuation of the study drug, a duration of up to 5 years for each participant.Population: The safety sample includes all participants who are randomized and receive at least one dose of study medication. The safety sample will include all safety outcomes from randomization until 30 days after permanent discontinuation of study drug.
Secondary safety outcome. This is the number of participants who had all-cause mortality during time of observation.
Outcome measures
| Measure |
Active Agent: Apixaban
n=482 Participants
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Apixaban
Apixaban: 5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose).
|
Active Control: Aspirin
n=493 Participants
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Aspirin
Aspirin: Aspirin 81 mg by mouth once daily.
|
|---|---|---|
|
Number of Participant Deaths From Any Cause Number of Participants With All-cause Mortality.
|
12 Participants
|
8 Participants
|
Adverse Events
Active Agent: Apixaban
Serious events: 355 serious events
Other events: 99 other events
Deaths: 32 deaths
Active Control: Aspirin
Serious events: 388 serious events
Other events: 91 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Active Agent: Apixaban
n=507 participants at risk
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Apixaban
Apixaban: 5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose).
|
Active Control: Aspirin
n=508 participants at risk
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Aspirin
Aspirin: Aspirin 81 mg by mouth once daily.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.99%
5/507 • Number of events 5 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.79%
4/508 • Number of events 4 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.39%
2/508 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrooesophageal cancer
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.39%
2/508 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Aphasia
|
0.39%
2/507 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Basal ganglia stroke
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Brain injury
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Cerebral infarction
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.6%
8/507 • Number of events 8 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
1.2%
6/508 • Number of events 7 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Embolic stroke
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Facial paralysis
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.39%
2/507 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.59%
3/508 • Number of events 3 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Hemiparesis
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Ischaemic stroke
|
5.7%
29/507 • Number of events 29 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
6.5%
33/508 • Number of events 33 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Migraine
|
0.39%
2/507 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.20%
1/507 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Quadriplegia
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Seizure
|
2.0%
10/507 • Number of events 11 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
2.0%
10/508 • Number of events 10 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Syncope
|
0.59%
3/507 • Number of events 3 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
1.2%
6/508 • Number of events 7 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.99%
5/507 • Number of events 5 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
1.4%
7/508 • Number of events 7 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Vertebral artery dissection
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Vertigo CNS origin
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
General disorders
Uncoded
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.39%
2/508 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Psychiatric disorders
Hallucination, visual
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Psychiatric disorders
Psychiatric decompensation
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.8%
9/507 • Number of events 10 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
1.2%
6/508 • Number of events 6 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Renal and urinary disorders
Haematuria
|
0.20%
1/507 • Number of events 5 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Renal and urinary disorders
Incontinence
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Renal and urinary disorders
Renal artery thrombosis
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Renal and urinary disorders
Renal haematoma
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Renal and urinary disorders
Renal impairment
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.59%
3/508 • Number of events 3 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.59%
3/507 • Number of events 3 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.79%
4/508 • Number of events 4 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.99%
5/507 • Number of events 5 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.59%
3/508 • Number of events 3 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Vascular disorders
Angiopathy
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Vascular disorders
Aortic aneurysm
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Vascular disorders
Arteriosclerosis
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Vascular disorders
Deep vein thrombosis
|
0.39%
2/507 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
1.2%
6/508 • Number of events 7 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Vascular disorders
Embolism
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Vascular disorders
Haematoma
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Vascular disorders
Hypertensive crisis
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Vascular disorders
Shock
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.4%
7/507 • Number of events 7 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
1.2%
6/508 • Number of events 6 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Angina unstable
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Atrial fibrillation
|
14.6%
74/507 • Number of events 74 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
15.2%
77/508 • Number of events 77 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Atrial flutter
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.79%
4/508 • Number of events 4 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Atrioventricular block
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.39%
2/508 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Cardiac dysfunction
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Cardiac failure
|
0.59%
3/507 • Number of events 3 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.79%
4/508 • Number of events 4 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Cardiac failure acute
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.59%
3/508 • Number of events 3 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.4%
7/507 • Number of events 8 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
1.6%
8/508 • Number of events 9 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Cardiogenic shock
|
0.39%
2/507 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Coronary artery disease
|
0.99%
5/507 • Number of events 5 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.98%
5/508 • Number of events 5 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Myocardial infarction
|
0.59%
3/507 • Number of events 3 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.59%
3/508 • Number of events 3 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Pericardial effusion
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Silent myocardial infarction
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.39%
2/508 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.59%
3/507 • Number of events 3 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.39%
2/508 • Number of events 4 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Eye disorders
Angle closure glaucoma
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Eye disorders
Retinal tear
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Dysphagia
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
6/507 • Number of events 6 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.98%
5/508 • Number of events 5 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Haematochezia
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.39%
2/507 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.39%
2/507 • Number of events 3 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
General disorders
Asthenia
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
General disorders
Chest pain
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.79%
4/508 • Number of events 4 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
General disorders
Death
|
0.99%
5/507 • Number of events 5 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.39%
2/508 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
General disorders
Necrosis
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
General disorders
Non-cardiac chest pain
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.39%
2/508 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Immune system disorders
Hypersensitivity
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.59%
3/508 • Number of events 3 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Clostridium difficile infection
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Corona virus infection
|
2.4%
12/507 • Number of events 14 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
1.4%
7/508 • Number of events 7 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Cystitis
|
0.39%
2/507 • Number of events 3 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Diverticulitis
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.39%
2/508 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Gangrene
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.39%
2/508 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Infected bite
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Kidney infection
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Pneumonia
|
2.6%
13/507 • Number of events 13 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
2.2%
11/508 • Number of events 12 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Pyelonephritis
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Sepsis
|
0.59%
3/507 • Number of events 3 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.98%
5/508 • Number of events 5 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Septic shock
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.39%
2/508 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Sialoadenitis
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Urinary tract infection
|
0.99%
5/507 • Number of events 5 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
1.4%
7/508 • Number of events 8 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Urosepsis
|
0.39%
2/507 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.39%
2/508 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.39%
2/508 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.39%
2/507 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.39%
2/508 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.79%
4/508 • Number of events 4 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.39%
2/507 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.79%
4/508 • Number of events 4 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.59%
3/507 • Number of events 3 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Investigations
Blood creatinine increased
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Investigations
Heart rate decreased
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Investigations
Transaminases increased
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.59%
3/508 • Number of events 3 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.39%
2/507 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Metabolism and nutrition disorders
Gout
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.39%
2/507 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.39%
2/507 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.39%
2/508 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.39%
2/508 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.39%
2/507 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
Other adverse events
| Measure |
Active Agent: Apixaban
n=507 participants at risk
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Apixaban
Apixaban: 5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose).
|
Active Control: Aspirin
n=508 participants at risk
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Aspirin
Aspirin: Aspirin 81 mg by mouth once daily.
|
|---|---|---|
|
Eye disorders
Amaurosis fugax
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Eye disorders
Diplopia
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.39%
2/507 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Haematochezia
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.59%
3/507 • Number of events 3 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Hepatobiliary disorders
Hepatitis
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Corona virus infection
|
6.5%
33/507 • Number of events 34 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
7.5%
38/508 • Number of events 38 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Infections and infestations
Urinary tract infection
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.2%
6/507 • Number of events 6 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
1.4%
7/508 • Number of events 7 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Injury
|
0.39%
2/507 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.39%
2/508 • Number of events 4 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Subarachnoid haematoma
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Investigations
Alanine aminotransferase increased
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Investigations
Aspartate aminotransferase increased
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Investigations
Coronavirus test positive
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Investigations
Hepatic enzyme increased
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Investigations
Polymerase chain reaction positive
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Investigations
Transaminases increased
|
0.39%
2/507 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.79%
4/507 • Number of events 4 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Ischaemic stroke
|
0.59%
3/507 • Number of events 3 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.39%
2/508 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.59%
3/507 • Number of events 3 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.79%
4/508 • Number of events 4 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Renal and urinary disorders
Haematuria
|
0.99%
5/507 • Number of events 5 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.79%
4/508 • Number of events 4 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.39%
2/507 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.8%
9/507 • Number of events 12 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.98%
5/508 • Number of events 5 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Vascular disorders
Bleeding varicose vein
|
0.20%
1/507 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.00%
0/508 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.20%
1/508 • Number of events 1 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Vascular disorders
Haematoma
|
0.39%
2/507 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.39%
2/508 • Number of events 3 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Vascular disorders
Haemorrhage
|
0.79%
4/507 • Number of events 4 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.98%
5/508 • Number of events 6 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
|
Vascular disorders
Subgaleal haematoma
|
0.00%
0/507 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
0.39%
2/508 • Number of events 2 • The adverse event data was collected for up to 5 years of study participation via questionnaires used at every follow-up visit. The all-cause mortalities were reported for all the randomized subjects through the whole follow up period of up to 5 plus the mortalities occurred during the adjudication process for the recurrent stroke (primary outcome) and the mortalities occurred more than 30 days after the study medication permanently stopped, up to 61 months.
SAE definition excludes these hospitalizations: to Emergency room/other hospital department \<24 hours, not resulting in admission (unless medically important/life-threatening); elective surgery planned prior to study entry; planned medical/surgical procedure; routine health assessment requiring medical/surgical admission other than to remedy ill health/planned prior to study entry; for another life circumstance w/o bearing on health status/requires no medical/surgical intervention.
|
Additional Information
Mitchell S.V. Elkind, MD, MS, FAHA/ Randolph S. Marshall, MD, MS (trial investigators)
Columbia University
Phone: 212-305-1710/ 212-305-8389
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place