Trial Outcomes & Findings for Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease (NCT NCT01776424)
NCT ID: NCT01776424
Last Updated: 2022-11-28
Results Overview
Count of participants and time from randomization to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
27395 participants
Primary outcome timeframe
For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
Results posted on
2022-11-28
Participant Flow
Study was conducted at 608 centers with randomized participants in 33 countries between 28 Feb 2013 (first patient first visit) and 15 Jun 2021 (last patient last visit of long-term open-label extension part).
Overall, 29872 participants were screened, of which 2477 participants were screen failures. A total of 27395 participants were randomized to antithrombotic treatment. 17598 participants were randomized to pantoprazole/placebo treatment. 12964 participants joined long-term open-label extension (LTOLE) part.
Participant milestones
| Measure |
Rivaroxaban 2.5mg + Aspirin 100mg
Participants received rivaroxaban 2.5 mg twice daily (bid) and aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.
|
Rivaroxaban 5mg + Aspirin Placebo
Participants received rivaroxaban 5 mg bid and aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.
|
Rivaroxaban Placebo + Aspirin 100mg
Participants received rivaroxaban placebo bid and aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.
|
|---|---|---|---|
|
Antithrombotic Part (Double Blind)
STARTED
|
9152
|
9117
|
9126
|
|
Antithrombotic Part (Double Blind)
Treated With Antithrombotic Treatment
|
9134
|
9109
|
9107
|
|
Antithrombotic Part (Double Blind)
Randomized to Study Pantoprazole/Placebo
|
5878
|
5859
|
5861
|
|
Antithrombotic Part (Double Blind)
COMPLETED
|
9132
|
9098
|
9102
|
|
Antithrombotic Part (Double Blind)
NOT COMPLETED
|
20
|
19
|
24
|
|
LTOLE Part (Open Label)
STARTED
|
4399
|
4292
|
4273
|
|
LTOLE Part (Open Label)
Treated in LTOLE Part
|
4379
|
4274
|
4250
|
|
LTOLE Part (Open Label)
COMPLETED
|
4320
|
4230
|
4195
|
|
LTOLE Part (Open Label)
NOT COMPLETED
|
79
|
62
|
78
|
Reasons for withdrawal
| Measure |
Rivaroxaban 2.5mg + Aspirin 100mg
Participants received rivaroxaban 2.5 mg twice daily (bid) and aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.
|
Rivaroxaban 5mg + Aspirin Placebo
Participants received rivaroxaban 5 mg bid and aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.
|
Rivaroxaban Placebo + Aspirin 100mg
Participants received rivaroxaban placebo bid and aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.
|
|---|---|---|---|
|
Antithrombotic Part (Double Blind)
Lost to Follow-up
|
10
|
8
|
9
|
|
Antithrombotic Part (Double Blind)
Withdrawal by Subject
|
10
|
11
|
15
|
|
LTOLE Part (Open Label)
Lost to Follow-up
|
6
|
2
|
5
|
|
LTOLE Part (Open Label)
Refused
|
5
|
2
|
11
|
|
LTOLE Part (Open Label)
Missing final visit
|
68
|
58
|
62
|
Baseline Characteristics
Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
Baseline characteristics by cohort
| Measure |
Rivaroxaban 2.5mg + Aspirin 100mg
n=9152 Participants
Participants received rivaroxaban 2.5 mg twice daily (bid) and aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.
|
Rivaroxaban 5mg + Aspirin Placebo
n=9117 Participants
Participants received rivaroxaban 5 mg bid and aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.
|
Rivaroxaban Placebo + Aspirin 100mg
n=9126 Participants
Participants received rivaroxaban placebo bid and aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.
|
Total
n=27395 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.3 Years
STANDARD_DEVIATION 7.9 • n=99 Participants
|
68.2 Years
STANDARD_DEVIATION 7.9 • n=107 Participants
|
68.2 Years
STANDARD_DEVIATION 8.0 • n=206 Participants
|
68.2 Years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
|
Sex: Female, Male
Female
|
2059 Participants
n=99 Participants
|
1972 Participants
n=107 Participants
|
1989 Participants
n=206 Participants
|
6020 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
7093 Participants
n=99 Participants
|
7145 Participants
n=107 Participants
|
7137 Participants
n=206 Participants
|
21375 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
388 Participants
n=99 Participants
|
381 Participants
n=107 Participants
|
376 Participants
n=206 Participants
|
1145 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1769 Participants
n=99 Participants
|
1751 Participants
n=107 Participants
|
1758 Participants
n=206 Participants
|
5278 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
5673 Participants
n=99 Participants
|
5672 Participants
n=107 Participants
|
5682 Participants
n=206 Participants
|
17027 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
South Asian
|
107 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
315 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other Asian
|
956 Participants
n=99 Participants
|
938 Participants
n=107 Participants
|
915 Participants
n=206 Participants
|
2809 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
76 Participants
n=99 Participants
|
94 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
262 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
183 Participants
n=99 Participants
|
179 Participants
n=107 Participants
|
197 Participants
n=206 Participants
|
559 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.Population: ITT: included all participants randomized to antithrombotic treatment for the initial study part. The ITT set comprised both participants randomized to pantoprazole/placebo and participants not randomized to pantoprazole/placebo.
Count of participants and time from randomization to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis.
Outcome measures
| Measure |
Rivaroxaban 2.5mg + Aspirin 100mg
n=9152 Participants
Participants received rivaroxaban 2.5 mg twice daily (bid) and aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
Rivaroxaban 5mg + Aspirin Placebo
n=9117 Participants
Participants received rivaroxaban 5 mg bid and aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
Rivaroxaban Placebo + Aspirin 100mg
n=9126 Participants
Participants received rivaroxaban placebo bid and aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
|---|---|---|---|
|
The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death
|
379 Participants
|
448 Participants
|
496 Participants
|
PRIMARY outcome
Timeframe: For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.Population: ITT: included all participants randomized to antithrombotic treatment for the initial study part. The ITT set comprised both participants randomized to pantoprazole/placebo and participants not randomized to pantoprazole/placebo.
Modified ISTH major bleeding is defined as: i) Fatal bleeding, or ii) Symptomatic bleeding in a critical area or organ, such as intraarticular, intracranial, intramuscular with compartment syndrome, intraocular, intraspinal, liver, pancreas, pericardial, respiratory, retroperitoneal, adrenal gland or kidney; or bleeding into the surgical site requiring reoperation, or iii) Bleeding leading to hospitalization (major bleeding also includes presentation to an acute care facility with discharge on the same day). Count of participants and time from randomization to the first occurrence of the primary safety outcome major bleeding were evaluated. Hazard ratios were calculated and reported as statistical analysis.
Outcome measures
| Measure |
Rivaroxaban 2.5mg + Aspirin 100mg
n=9152 Participants
Participants received rivaroxaban 2.5 mg twice daily (bid) and aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
Rivaroxaban 5mg + Aspirin Placebo
n=9117 Participants
Participants received rivaroxaban 5 mg bid and aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
Rivaroxaban Placebo + Aspirin 100mg
n=9126 Participants
Participants received rivaroxaban placebo bid and aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
|---|---|---|---|
|
The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria
|
288 Participants
|
255 Participants
|
170 Participants
|
SECONDARY outcome
Timeframe: For each participant, the first occurrence of MI, ALI, or CHD death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.Population: ITT: included all participants randomized to antithrombotic treatment for the initial study part. The ITT set comprised both participants randomized to pantoprazole/placebo and participants not randomized to pantoprazole/placebo.
Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CHD death were evaluated. Hazard ratios were calculated and reported as statistical analysis.
Outcome measures
| Measure |
Rivaroxaban 2.5mg + Aspirin 100mg
n=9152 Participants
Participants received rivaroxaban 2.5 mg twice daily (bid) and aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
Rivaroxaban 5mg + Aspirin Placebo
n=9117 Participants
Participants received rivaroxaban 5 mg bid and aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
Rivaroxaban Placebo + Aspirin 100mg
n=9126 Participants
Participants received rivaroxaban placebo bid and aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
|---|---|---|---|
|
The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death
|
329 Participants
|
397 Participants
|
450 Participants
|
SECONDARY outcome
Timeframe: For each participant, the first occurrence of MI, ischemic stroke, ALI, or CV death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.Population: ITT: included all participants randomized to antithrombotic treatment for the initial study part. The ITT set comprised both participants randomized to pantoprazole/placebo and participants not randomized to pantoprazole/placebo.
Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis.
Outcome measures
| Measure |
Rivaroxaban 2.5mg + Aspirin 100mg
n=9152 Participants
Participants received rivaroxaban 2.5 mg twice daily (bid) and aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
Rivaroxaban 5mg + Aspirin Placebo
n=9117 Participants
Participants received rivaroxaban 5 mg bid and aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
Rivaroxaban Placebo + Aspirin 100mg
n=9126 Participants
Participants received rivaroxaban placebo bid and aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
|---|---|---|---|
|
The First Occurrence of MI, Ischemic Stroke, ALI, or Cardiovascular (CV) Death
|
389 Participants
|
453 Participants
|
516 Participants
|
SECONDARY outcome
Timeframe: For each participants, death by any cause after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.Population: ITT: included all participants randomized to antithrombotic treatment for the initial study part. The ITT set comprised both participants randomized to pantoprazole/placebo and participants not randomized to pantoprazole/placebo.
Count of participants and time from randomization to death by all cause were evaluated. Hazard ratios were calculated and reported as statistical analysis.
Outcome measures
| Measure |
Rivaroxaban 2.5mg + Aspirin 100mg
n=9152 Participants
Participants received rivaroxaban 2.5 mg twice daily (bid) and aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
Rivaroxaban 5mg + Aspirin Placebo
n=9117 Participants
Participants received rivaroxaban 5 mg bid and aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
Rivaroxaban Placebo + Aspirin 100mg
n=9126 Participants
Participants received rivaroxaban placebo bid and aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
|---|---|---|---|
|
All-cause Mortality
|
313 Participants
|
366 Participants
|
378 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For each participant, the first occurrence of the composite primary efficacy outcome after from COMPASS LTOLE initiation visit up until last LTOLE part contact date was considered. The mean time in follow-up was 428 days.Population: LTOLE ITT: included all participants who completed COMPASS LTOLE initiation visit (LTOLE initiation visit date entered).
Count of participants from COMPASS LTOLE initiation visit to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. LTOLE: long-term open-lable extension
Outcome measures
| Measure |
Rivaroxaban 2.5mg + Aspirin 100mg
n=12964 Participants
Participants received rivaroxaban 2.5 mg twice daily (bid) and aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
Rivaroxaban 5mg + Aspirin Placebo
Participants received rivaroxaban 5 mg bid and aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
Rivaroxaban Placebo + Aspirin 100mg
Participants received rivaroxaban placebo bid and aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
|---|---|---|---|
|
The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death in LTOLE Part
|
353 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For each participant, the first occurrence of modified ISTH major bleeding from COMPASS LTOLE initiation visit up until 2 days after the last treatment in LTOLE part was considered. The mean time in follow-up was 421 days.Population: LTOLE SAF: included all participants who completed COMPASS LTOLE initiation visit and who received at least one dose of medication in LTOLE part.
Modified ISTH major bleeding is defined as: i) Fatal bleeding, or ii) Symptomatic bleeding in a critical area or organ, such as intraarticular, intracranial, intramuscular with compartment syndrome, intraocular, intraspinal, liver, pancreas, pericardial, respiratory, retroperitoneal, adrenal gland or kidney; or bleeding into the surgical site requiring reoperation, or iii) Bleeding leading to hospitalization (major bleeding also includes presentation to an acute care facility with discharge on the same day). Count of participants from COMPASS LTOLE initiation visit to the first occurrence of the primary safety outcome major bleeding was evaluated. LTOLE: long-term open-lable extension
Outcome measures
| Measure |
Rivaroxaban 2.5mg + Aspirin 100mg
n=12903 Participants
Participants received rivaroxaban 2.5 mg twice daily (bid) and aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
Rivaroxaban 5mg + Aspirin Placebo
Participants received rivaroxaban 5 mg bid and aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
Rivaroxaban Placebo + Aspirin 100mg
Participants received rivaroxaban placebo bid and aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
|---|---|---|---|
|
The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria in LTOLE Part
|
138 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For each participants, death by any cause after COMPASS LTOLE initiation visit up until the the last LTOLE part contact date was considered. The mean time in follow-up until that date was 428 days.Population: LTOLE ITT: included all participants who completed COMPASS LTOLE initiation visit (LTOLE initiation visit date entered).
Count of participants from COMPASS LTOLE initiation visit to death by all cause were evaluated. LTOLE: long-term open-lable extension
Outcome measures
| Measure |
Rivaroxaban 2.5mg + Aspirin 100mg
n=12964 Participants
Participants received rivaroxaban 2.5 mg twice daily (bid) and aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
Rivaroxaban 5mg + Aspirin Placebo
Participants received rivaroxaban 5 mg bid and aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
Rivaroxaban Placebo + Aspirin 100mg
Participants received rivaroxaban placebo bid and aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
|
|---|---|---|---|
|
All-cause Mortality in LTOLE Part
|
282 Participants
|
—
|
—
|
Adverse Events
Rivaroxaban 2.5mg + Aspirin 100mg
Serious events: 692 serious events
Other events: 557 other events
Deaths: 529 deaths
Rivaroxaban 5mg + Aspirin Placebo
Serious events: 664 serious events
Other events: 529 other events
Deaths: 566 deaths
Rivaroxaban Placebo + Aspirin 100mg
Serious events: 630 serious events
Other events: 501 other events
Deaths: 566 deaths
LTOLE Rivaroxaban Rivaroxaban 2.5mg + Aspirin 100mg
Serious events: 292 serious events
Other events: 49 other events
Deaths: 283 deaths
Serious adverse events
| Measure |
Rivaroxaban 2.5mg + Aspirin 100mg
n=9134 participants at risk
Participants received Rivaroxaban 2.5 mg twice daily (bid) and Aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration.
|
Rivaroxaban 5mg + Aspirin Placebo
n=9109 participants at risk
Participants received Rivaroxaban 5 mg bid and Aspirin placebo od. All doses were provided in tablet form for oral administration.
|
Rivaroxaban Placebo + Aspirin 100mg
n=9107 participants at risk
Participants received Rivaroxaban placebo bid and Aspirin 100 mg od. All doses were provided in tablet form for oral administration.
|
LTOLE Rivaroxaban Rivaroxaban 2.5mg + Aspirin 100mg
n=12903 participants at risk
LTOLE Participants received Rivaroxaban 2.5 mg twice daily (bid) and Aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.14%
13/9134 • Number of events 14 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.11%
10/9109 • Number of events 11 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
5/12903 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.03%
3/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.03%
3/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
3/12903 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Blood and lymphatic system disorders
Pernicious anaemia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.05%
5/9134 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Blood and lymphatic system disorders
Hypereosinophilic syndrome
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Blood and lymphatic system disorders
Blood disorder
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Angina pectoris
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9107 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Arrhythmia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Atrial fibrillation
|
0.04%
4/9134 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9109 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.11%
10/9107 • Number of events 10 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
3/12903 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9107 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Bradycardia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Cardiac arrest
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Coronary artery disease
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Dressler's syndrome
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Coronary artery perforation
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Congenital, familial and genetic disorders
Fabry's disease
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Ear and labyrinth disorders
Vertigo
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9109 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.07%
6/9107 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Endocrine disorders
Toxic nodular goitre
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Endocrine disorders
Thyroid mass
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Amaurosis fugax
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Blindness transient
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Cataract
|
0.19%
17/9134 • Number of events 20 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.12%
11/9109 • Number of events 13 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.08%
7/9107 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Cataract cortical
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Cataract nuclear
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Diplopia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Eyelid ptosis
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Glaucoma
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Macular oedema
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Ophthalmoplegia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Pterygium
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Retinal artery occlusion
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Retinal detachment
|
0.03%
3/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Retinal vein thrombosis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Sudden visual loss
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Vision blurred
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Visual impairment
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Vitreous haemorrhage
|
0.02%
2/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Macular hole
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Tolosa-Hunt syndrome
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Entropion
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Retinal vascular thrombosis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Age-related macular degeneration
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.05%
5/9134 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
4/9109 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9107 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
4/9109 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9107 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Constipation
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.04%
4/9134 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9109 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9107 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Food poisoning
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Gallstone ileus
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Gastritis
|
0.07%
6/9134 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9107 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Gastritis alcoholic
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.05%
5/9134 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Ileus
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.05%
5/9134 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
4/9109 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9107 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Melaena
|
0.04%
4/9134 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.05%
5/9134 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.10%
9/9109 • Number of events 10 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.09%
8/9107 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.06%
8/12903 • Number of events 8 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.07%
6/9134 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9109 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.11%
10/9107 • Number of events 10 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
5/12903 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Pancreatitis haemorrhagic
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Spigelian hernia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Stomatitis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Vomiting
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Subileus
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Dyschezia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.09%
8/9134 • Number of events 8 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.15%
14/9109 • Number of events 14 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.10%
9/9107 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Oesophageal rupture
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Faecaloma
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Gastric mucosal lesion
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Omental infarction
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Ischaemic enteritis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Subacute pancreatitis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Asthenia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9109 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Chest discomfort
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Chest pain
|
0.10%
9/9134 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.15%
14/9109 • Number of events 14 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9107 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Death
|
0.03%
3/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9109 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.08%
7/9107 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
5/12903 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Euthanasia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Face oedema
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Gait disturbance
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Generalised oedema
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Hernia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Impaired healing
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Malaise
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9109 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Oedema peripheral
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Pain
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Pyrexia
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Sudden death
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Peripheral swelling
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
General physical health deterioration
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Nodule
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Unevaluable event
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Non-cardiac chest pain
|
0.11%
10/9134 • Number of events 10 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9109 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.09%
8/9107 • Number of events 8 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Accidental death
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9109 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Stent-graft endoleak
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Medical device site erosion
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Vascular stent stenosis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.03%
3/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Lithiasis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.04%
4/9134 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9109 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Hepatobiliary disorders
Cholangitis
|
0.03%
3/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9107 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.11%
10/9134 • Number of events 10 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.10%
9/9109 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.13%
12/9107 • Number of events 12 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.07%
6/9134 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.09%
8/9109 • Number of events 8 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.10%
9/9107 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.04%
4/9134 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.07%
6/9107 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Hepatobiliary disorders
Cholestasis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Hepatobiliary disorders
Hepatitis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Hepatobiliary disorders
Jaundice
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Hepatobiliary disorders
Hepatic mass
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Immune system disorders
Anaphylactic reaction
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Immune system disorders
Contrast media reaction
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Immune system disorders
Food allergy
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Immune system disorders
Hypersensitivity
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Abscess oral
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Appendicitis
|
0.03%
3/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.08%
7/9109 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
3/12903 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Appendicitis perforated
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Brain abscess
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Bronchitis
|
0.03%
3/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9109 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Cellulitis
|
0.10%
9/9134 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.12%
11/9109 • Number of events 12 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.09%
8/9107 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
3/12903 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Cystitis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Dermatitis infected
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Diverticulitis
|
0.05%
5/9134 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
4/9109 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9107 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Diverticulitis intestinal haemorrhagic
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Ear lobe infection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Encephalitis viral
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Erysipelas
|
0.03%
3/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9109 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.07%
6/9107 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
4/12903 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Fournier's gangrene
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Gangrene
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Gastroenteritis
|
0.05%
5/9134 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9109 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
4/9107 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Herpes zoster
|
0.04%
4/9134 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Influenza
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
3/12903 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Labyrinthitis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Localised infection
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Meningitis aseptic
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Necrotising fasciitis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Orchitis
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Osteomyelitis
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Periodontitis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Peritonitis
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Pharyngitis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Pneumonia
|
0.16%
15/9134 • Number of events 16 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.23%
21/9109 • Number of events 26 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.24%
22/9107 • Number of events 22 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.13%
17/12903 • Number of events 17 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Postoperative wound infection
|
0.02%
2/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
4/9109 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9107 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Pyelitis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Pyelonephritis
|
0.03%
3/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9107 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Pyelonephritis acute
|
0.01%
1/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Renal abscess
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Sepsis
|
0.20%
18/9134 • Number of events 20 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.20%
18/9109 • Number of events 18 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.19%
17/9107 • Number of events 17 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
6/12903 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Septic shock
|
0.03%
3/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.08%
7/9109 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.08%
7/9107 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
4/12903 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Skin infection
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Superinfection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Tooth abscess
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Tuberculosis
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Urinary tract infection
|
0.19%
17/9134 • Number of events 19 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.15%
14/9109 • Number of events 15 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.10%
9/9107 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
7/12903 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Viral myocarditis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Wound infection
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9109 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.09%
8/9107 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Urosepsis
|
0.10%
9/9134 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
4/9109 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.07%
6/9107 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.06%
8/12903 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Vaginal abscess
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Groin abscess
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Campylobacter infection
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Pulmonary sepsis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
3/12903 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Neuroborreliosis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Arthritis bacterial
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Subdiaphragmatic abscess
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Periorbital cellulitis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Biliary sepsis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Cerebral toxoplasmosis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Infected cyst
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Implant site infection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Intervertebral discitis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Diabetic foot infection
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9109 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9109 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Klebsiella infection
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Borrelia infection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Keratitis bacterial
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Mycobacterial infection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Cholecystitis infective
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Device related infection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Biliary tract infection bacterial
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Post procedural sepsis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Post procedural infection
|
0.03%
3/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Infectious pleural effusion
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Cholangitis infective
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Medical device site joint infection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Infected bite
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Bacterial abdominal infection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Complicated appendicitis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Nephritis bacterial
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
COVID-19
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
5/12903 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Blindness traumatic
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Syncope
|
0.05%
5/9134 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.08%
7/9109 • Number of events 8 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9107 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
4/12903 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Chemical poisoning
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.03%
3/9134 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.04%
4/9134 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Incisional hernia, obstructive
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Injury
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Poisoning deliberate
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.04%
4/9134 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
6/12903 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Spinal cord injury cervical
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Vascular injury
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Wound evisceration
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Postoperative renal failure
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Bladder injury
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Vascular bypass dysfunction
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Vascular anastomosis aneurysm
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Temporal lobe epilepsy
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Airway burns
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Amylase increased
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Biopsy prostate
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Blood glucose abnormal
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Blood pressure increased
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Bronchoscopy
|
0.01%
1/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Catheterisation cardiac
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Colonoscopy
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Haemoglobin decreased
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
HIV test positive
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Lipase increased
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Liver function test abnormal
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Weight decreased
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Urological examination
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Computerised tomogram thorax
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Angiogram peripheral
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Blood electrolytes abnormal
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Stenotrophomonas test positive
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Influenza A virus test positive
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Hepatitis B core antibody positive
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Angiocardiogram
|
0.11%
10/9134 • Number of events 12 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.10%
9/9109 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.13%
12/9107 • Number of events 14 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.04%
4/9134 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9109 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.04%
4/9134 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9109 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.07%
6/9107 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9109 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9107 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Monoplegia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Metabolism and nutrition disorders
Gout
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
4/9109 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.03%
3/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9109 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
4/12903 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Metabolism and nutrition disorders
Marasmus
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.03%
3/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9109 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.03%
3/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.03%
3/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.05%
5/9134 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.07%
6/9109 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.09%
8/9107 • Number of events 8 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthropathy
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
4/9107 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
4/9109 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.02%
2/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Spondyloarthropathy
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Seronegative arthritis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Spinal synovial cyst
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.01%
1/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Biliary neoplasm
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.08%
7/9107 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.07%
6/9134 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.11%
10/9134 • Number of events 10 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.07%
6/9109 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
4/9107 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage IV
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.09%
8/9134 • Number of events 8 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.09%
8/9109 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.07%
6/9107 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal cancer
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal neoplasm
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9107 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of renal pelvis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of spermatic cord
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma malignant
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to neck
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9109 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.08%
7/9107 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9107 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.04%
4/9134 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9109 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penile cancer
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia vera
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal cancer
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma metastatic
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the cervix
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9107 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tracheal cancer
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.03%
3/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.03%
3/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9107 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.19%
17/9134 • Number of events 18 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.15%
14/9109 • Number of events 14 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.12%
11/9107 • Number of events 12 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.06%
8/12903 • Number of events 8 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extradural neoplasm
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.14%
13/9134 • Number of events 13 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.11%
10/9109 • Number of events 10 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
4/9107 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
4/12903 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign renal neoplasm
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant mesenchymoma
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peripheral nervous system neoplasm
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Splenic marginal zone lymphoma
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsillar neoplasm
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrooesophageal cancer
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage 0
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ameloblastoma
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer metastatic
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papillary mucinous neoplasm
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9107 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
3/12903 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.04%
4/9134 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system neuroblastoma
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal gland cancer
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine benign neoplasm
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary cystadenoma lymphomatosum
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour of the lung
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma metastatic
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular lymphoma
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Altered state of consciousness
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Cerebral infarction
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Cerebral venous thrombosis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Dementia
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Demyelination
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Dizziness
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Encephalopathy
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Headache
|
0.03%
3/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9109 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Hemianopia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Loss of consciousness
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Migraine
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Motor neurone disease
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Nerve compression
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Paraesthesia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Presyncope
|
0.01%
1/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Sciatica
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Seizure
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9109 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Spinal cord compression
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Status epilepticus
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Neuromuscular pain
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Psychiatric disorders
Alcohol abuse
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Psychiatric disorders
Completed suicide
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9109 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Psychiatric disorders
Confusional state
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Psychiatric disorders
Delirium
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Psychiatric disorders
Depression
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Psychiatric disorders
Mania
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Psychiatric disorders
Stereotypy
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Psychiatric disorders
Suicide attempt
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Azotaemia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Calculus bladder
|
0.03%
3/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Calculus urinary
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Haematuria
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.07%
6/9134 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9107 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Renal failure
|
0.09%
8/9134 • Number of events 8 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.07%
6/9109 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9107 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Urinary retention
|
0.03%
3/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Urogenital disorder
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Bladder mass
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Renal impairment
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.04%
4/9134 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9107 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.32%
29/9134 • Number of events 30 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.24%
22/9109 • Number of events 22 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.22%
20/9107 • Number of events 20 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.06%
8/12903 • Number of events 8 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Prerenal failure
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.08%
7/9134 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Reproductive system and breast disorders
Prostatic haemorrhage
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.04%
4/9134 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
4/9109 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.09%
8/9107 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.04%
4/9134 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.12%
11/9109 • Number of events 11 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.07%
6/9107 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
5/12903 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9109 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
4/9107 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.04%
4/9134 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9109 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
4/9107 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary vasculitis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.05%
5/9134 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.08%
7/9109 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.08%
7/9107 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
3/12903 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial polyp
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mass
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Acquired diaphragmatic eventration
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Cough variant asthma
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Acute interstitial pneumonitis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Negative pressure pulmonary oedema
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.01%
1/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
4/9109 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9107 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity vasculitis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.02%
2/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Urticaria chronic
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.02%
2/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Leukoplakia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Capillaritis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Social circumstances
Pregnancy of partner
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Carotid endarterectomy
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Coronary artery surgery
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Foot amputation
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Gastric polypectomy
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Hernia hiatus repair
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.02%
2/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Mole excision
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Nasal polypectomy
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Ptosis repair
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Glaucoma surgery
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Diabetes mellitus management
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Transurethral bladder resection
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Sigmoidectomy
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Peripheral artery angioplasty
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Joint arthroplasty
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Hernia repair
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Tooth extraction
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Shoulder operation
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Cataract operation
|
0.02%
2/9134 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9109 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.07%
6/9107 • Number of events 8 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Bladder neoplasm surgery
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Gastrointestinal endoscopic therapy
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Vascular graft
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Stoma closure
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Catheter management
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Surgical and medical procedures
Large intestinal polypectomy
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Aortic aneurysm
|
0.02%
2/9134 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Aortic thrombosis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Circulatory collapse
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Embolism arterial
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Hypertension
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Hypertensive crisis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Hypotension
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
3/12903 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Renovascular hypertension
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Varicose ulceration
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Dry gangrene
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Haemodynamic instability
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Iliac artery stenosis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Hypertensive urgency
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Aortic rupture
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.04%
4/9134 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9107 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Atheroembolism
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Peripheral artery aneurysm rupture
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Vertigo CNS origin
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
VIth nerve paralysis
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Cerebral haematoma
|
0.01%
1/9134 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/9109 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Putamen haemorrhage
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9109 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/9134 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9109 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/9107 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
Other adverse events
| Measure |
Rivaroxaban 2.5mg + Aspirin 100mg
n=9134 participants at risk
Participants received Rivaroxaban 2.5 mg twice daily (bid) and Aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration.
|
Rivaroxaban 5mg + Aspirin Placebo
n=9109 participants at risk
Participants received Rivaroxaban 5 mg bid and Aspirin placebo od. All doses were provided in tablet form for oral administration.
|
Rivaroxaban Placebo + Aspirin 100mg
n=9107 participants at risk
Participants received Rivaroxaban placebo bid and Aspirin 100 mg od. All doses were provided in tablet form for oral administration.
|
LTOLE Rivaroxaban Rivaroxaban 2.5mg + Aspirin 100mg
n=12903 participants at risk
LTOLE Participants received Rivaroxaban 2.5 mg twice daily (bid) and Aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.15%
14/9134 • Number of events 24 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.12%
11/9109 • Number of events 13 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.10%
9/9107 • Number of events 11 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
4/12903 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.09%
8/9134 • Number of events 10 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.13%
12/9109 • Number of events 16 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/9107 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Cardiac disorders
Atrial fibrillation
|
0.26%
24/9134 • Number of events 41 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.20%
18/9109 • Number of events 32 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.20%
18/9107 • Number of events 27 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
7/12903 • Number of events 11 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Ear and labyrinth disorders
Vertigo
|
0.11%
10/9134 • Number of events 13 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.14%
13/9109 • Number of events 19 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.16%
15/9107 • Number of events 19 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Cataract
|
0.13%
12/9134 • Number of events 12 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.16%
15/9109 • Number of events 16 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.13%
12/9107 • Number of events 13 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.11%
10/9134 • Number of events 13 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.12%
11/9109 • Number of events 14 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9107 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.19%
17/9134 • Number of events 32 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.11%
10/9109 • Number of events 20 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.10%
9/9107 • Number of events 16 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
4/12903 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.08%
7/9134 • Number of events 10 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.13%
12/9109 • Number of events 23 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9107 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.31%
28/9134 • Number of events 42 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.20%
18/9109 • Number of events 30 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.23%
21/9107 • Number of events 28 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
5/12903 • Number of events 10 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Constipation
|
0.28%
26/9134 • Number of events 33 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.20%
18/9109 • Number of events 20 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.26%
24/9107 • Number of events 37 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Dental caries
|
0.16%
15/9134 • Number of events 15 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.13%
12/9109 • Number of events 13 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.11%
10/9107 • Number of events 10 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.53%
48/9134 • Number of events 65 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.64%
58/9109 • Number of events 79 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.29%
26/9107 • Number of events 32 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
5/12903 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.15%
14/9134 • Number of events 19 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.13%
12/9109 • Number of events 20 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.16%
15/9107 • Number of events 24 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Gastritis
|
0.21%
19/9134 • Number of events 28 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.08%
7/9109 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.14%
13/9107 • Number of events 21 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.12%
11/9134 • Number of events 13 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.12%
11/9109 • Number of events 13 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.07%
6/9107 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Nausea
|
0.23%
21/9134 • Number of events 30 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.19%
17/9109 • Number of events 26 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.15%
14/9107 • Number of events 21 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
4/12903 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Stomatitis
|
0.13%
12/9134 • Number of events 12 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.13%
12/9109 • Number of events 12 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
4/9107 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Vomiting
|
0.09%
8/9134 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.09%
8/9109 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.12%
11/9107 • Number of events 14 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.18%
16/9134 • Number of events 17 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.13%
12/9109 • Number of events 14 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.09%
8/9107 • Number of events 8 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Chest discomfort
|
0.05%
5/9134 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9109 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.11%
10/9107 • Number of events 10 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Chest pain
|
0.08%
7/9134 • Number of events 11 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.09%
8/9109 • Number of events 11 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.11%
10/9107 • Number of events 10 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Oedema peripheral
|
0.03%
3/9134 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.08%
7/9109 • Number of events 8 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.13%
12/9107 • Number of events 15 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
General disorders
Pyrexia
|
0.07%
6/9134 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.11%
10/9109 • Number of events 10 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.09%
8/9107 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Bronchitis
|
0.15%
14/9134 • Number of events 15 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.08%
7/9109 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.14%
13/9107 • Number of events 13 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Cystitis
|
0.07%
6/9134 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.11%
10/9109 • Number of events 13 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.08%
7/9107 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Gastroenteritis
|
0.18%
16/9134 • Number of events 21 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.11%
10/9109 • Number of events 10 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.11%
10/9107 • Number of events 11 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Herpes zoster
|
0.10%
9/9134 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.16%
15/9109 • Number of events 15 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.21%
19/9107 • Number of events 21 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Influenza
|
0.20%
18/9134 • Number of events 18 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.15%
14/9109 • Number of events 16 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.26%
24/9107 • Number of events 25 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
188/9134 • Number of events 284 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
2.0%
181/9109 • Number of events 284 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
2.1%
195/9107 • Number of events 289 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Periodontitis
|
0.13%
12/9134 • Number of events 13 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.12%
11/9109 • Number of events 11 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.13%
12/9107 • Number of events 12 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Infections and infestations
Pharyngitis
|
0.09%
8/9134 • Number of events 8 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.08%
7/9109 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.11%
10/9107 • Number of events 11 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.41%
37/9134 • Number of events 42 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.24%
22/9109 • Number of events 26 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.30%
27/9107 • Number of events 41 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.12%
11/9134 • Number of events 12 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
4/9109 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9107 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Investigations
Occult blood positive
|
0.13%
12/9134 • Number of events 12 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.08%
7/9109 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.03%
3/9107 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.28%
26/9134 • Number of events 27 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.18%
16/9109 • Number of events 16 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.31%
28/9107 • Number of events 28 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.31%
28/9134 • Number of events 32 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.29%
26/9109 • Number of events 31 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.33%
30/9107 • Number of events 36 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.27%
25/9134 • Number of events 27 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.41%
37/9109 • Number of events 39 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.27%
25/9107 • Number of events 27 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.11%
10/9134 • Number of events 10 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9109 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.07%
6/9107 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.11%
10/9134 • Number of events 11 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.11%
10/9109 • Number of events 12 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.07%
6/9107 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.07%
6/9134 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.15%
14/9109 • Number of events 18 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.14%
13/9107 • Number of events 14 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.05%
5/9134 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.11%
10/9109 • Number of events 10 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.09%
8/9107 • Number of events 10 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.15%
14/9134 • Number of events 19 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.09%
8/9109 • Number of events 10 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.10%
9/9107 • Number of events 12 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.11%
10/9134 • Number of events 10 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.08%
7/9109 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.09%
8/9107 • Number of events 8 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Dizziness
|
0.27%
25/9134 • Number of events 41 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.27%
25/9109 • Number of events 36 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.38%
35/9107 • Number of events 42 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Headache
|
0.22%
20/9134 • Number of events 31 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.23%
21/9109 • Number of events 32 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.24%
22/9107 • Number of events 32 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
2/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Nervous system disorders
Hypoaesthesia
|
0.08%
7/9134 • Number of events 7 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.09%
8/9109 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.13%
12/9107 • Number of events 15 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Psychiatric disorders
Insomnia
|
0.07%
6/9134 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.13%
12/9109 • Number of events 14 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
4/9107 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Renal and urinary disorders
Haematuria
|
0.25%
23/9134 • Number of events 31 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.16%
15/9109 • Number of events 25 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.08%
7/9107 • Number of events 8 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
3/12903 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.08%
7/9134 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.13%
12/9109 • Number of events 18 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.12%
11/9107 • Number of events 13 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.42%
38/9134 • Number of events 73 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.32%
29/9109 • Number of events 45 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.26%
24/9107 • Number of events 29 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.11%
10/9134 • Number of events 25 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9109 • Number of events 6 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9107 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.11%
10/9134 • Number of events 11 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.09%
8/9109 • Number of events 9 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.04%
4/9107 • Number of events 4 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.19%
17/9134 • Number of events 23 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.21%
19/9109 • Number of events 25 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.22%
20/9107 • Number of events 22 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.54%
49/9134 • Number of events 86 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.20%
18/9109 • Number of events 23 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.19%
17/9107 • Number of events 29 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.00%
0/12903 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.21%
19/9134 • Number of events 27 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.25%
23/9109 • Number of events 37 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.19%
17/9107 • Number of events 21 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 1 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.13%
12/9134 • Number of events 22 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.18%
16/9109 • Number of events 31 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.20%
18/9107 • Number of events 30 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.02%
3/12903 • Number of events 3 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.12%
11/9134 • Number of events 13 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.12%
11/9109 • Number of events 11 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.05%
5/9107 • Number of events 5 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
|
Vascular disorders
Hypertension
|
0.27%
25/9134 • Number of events 25 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.18%
16/9109 • Number of events 18 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.12%
11/9107 • Number of events 11 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
0.01%
1/12903 • Number of events 2 • Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group).
During LTOLE part, all participants had stopped randomized treatments and received rivaroxaban 2.5mg+aspirin 100mg od. AEs were collected for safety analysis set (all randomized participants who received at least one dose of antithrombotic study drug). All-Cause Mortality encompasses all deaths in Intent-to-treat analysis set (all randomized participants and/or all who completed LTOLE part initiation visit). 2 participants were treated in LTOLE part never treated in the antithrombotic part.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Global principal investigator (PI) to provide to Bayer for review any proposed Publication/oral presentation relating to Study/Study Drug/Results at least 45 days prior to submission or presentation of the Publication. Abstracts to be provided to Bayer 5 working days before Publication. Bayer may provide comments within the applicable period. Under certain circumstances Bayer may request a further delay of publications to avoid adverse effects on a Bayer patent application.
- Publication restrictions are in place
Restriction type: OTHER