Trial Outcomes & Findings for A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart (NCT NCT02415400)
NCT ID: NCT02415400
Last Updated: 2020-06-11
Results Overview
Time to first ISTH major or CRNM bleeding during the 6-month period of treatment with Apixaban or VKA. N is the number of participants treated with Apixaban or VKA. n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with major or CRNM bleeding divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
4614 participants
Primary outcome timeframe
Approximately 6 months
Results posted on
2020-06-11
Participant Flow
4683 participants enrolled, 4614 randomized. Reasons not randomized: 2 adverse event; 1 request to stop therapy; 12 withdrew consent; 1 lost to follow-up; 1 poor/non-compliance; 35 no longer met criteria; 2 admin reasons by Sponsor; 10 lack of IP at site; 1 IWRS down; 2 physician recommended; 1 leaving the country; 1 pharmacogenetic sample positive
Participant milestones
| Measure |
Apixaban With Acetylsalicylic Acid Film Coated Tablet
5 mg or 2.5 mg Apixaban tablets orally twice per day with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
|
Apixaban With Placebo Matching Acetylsalicylic Acid
5 mg or 2.5 mg Apixaban tablets orally twice per day with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
|
Vitamin K Antagonist (VKA) With Acetylsalicylic Acid
VKA tablets orally once daily with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
|
VKA With Placebo Matching Acetylsalicylic Acid
VKA tablets orally once daily with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1153
|
1153
|
1154
|
1154
|
|
Overall Study
COMPLETED
|
1087
|
1091
|
1069
|
1071
|
|
Overall Study
NOT COMPLETED
|
66
|
62
|
85
|
83
|
Reasons for withdrawal
| Measure |
Apixaban With Acetylsalicylic Acid Film Coated Tablet
5 mg or 2.5 mg Apixaban tablets orally twice per day with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
|
Apixaban With Placebo Matching Acetylsalicylic Acid
5 mg or 2.5 mg Apixaban tablets orally twice per day with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
|
Vitamin K Antagonist (VKA) With Acetylsalicylic Acid
VKA tablets orally once daily with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
|
VKA With Placebo Matching Acetylsalicylic Acid
VKA tablets orally once daily with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
2
|
|
Overall Study
Participant request to stop therapy
|
4
|
3
|
8
|
6
|
|
Overall Study
Participant withdrew consent
|
14
|
12
|
30
|
21
|
|
Overall Study
Death
|
39
|
41
|
35
|
42
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
2
|
5
|
|
Overall Study
Poor/Non-Compliance
|
0
|
1
|
3
|
4
|
|
Overall Study
Participant no longer meets criteria
|
2
|
0
|
0
|
1
|
|
Overall Study
Participant doesn't answer phone
|
1
|
0
|
0
|
0
|
|
Overall Study
Participant wanted home visits
|
1
|
0
|
0
|
0
|
|
Overall Study
Randomized in error
|
2
|
0
|
0
|
0
|
|
Overall Study
No study drug on site
|
0
|
1
|
0
|
0
|
|
Overall Study
Stroke and stroke rehabilitation
|
0
|
0
|
1
|
0
|
|
Overall Study
Coagulation values cannot be set
|
0
|
0
|
1
|
0
|
|
Overall Study
State regulations prevent participation
|
0
|
0
|
1
|
0
|
|
Overall Study
Poor treatment monitoring
|
0
|
0
|
1
|
0
|
|
Overall Study
Participant in jail
|
0
|
0
|
1
|
0
|
|
Overall Study
Investigator decision
|
0
|
0
|
1
|
1
|
|
Overall Study
Site closure; participant won't transfer
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart
Baseline characteristics by cohort
| Measure |
Apixaban With Acetylsalicylic Acid Film Coated Tablet
n=1153 Participants
5 mg or 2.5 mg Apixaban tablets orally twice per day with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
|
Apixaban With Placebo Matching Acetylsalicylic Acid
n=1153 Participants
5 mg or 2.5 mg Apixaban tablets orally twice per day with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
|
Vitamin K Antagonist (VKA) With Acetylsalicylic
n=1154 Participants
VKA tablets orally once daily with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
|
VKA With Placebo Matching Acetylsalicylic Acid
n=1154 Participants
VKA tablets orally once daily with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
|
Total
n=4614 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
70.2 Years
STANDARD_DEVIATION 9.12 • n=5 Participants
|
69.3 Years
STANDARD_DEVIATION 9.32 • n=7 Participants
|
70.0 Years
STANDARD_DEVIATION 9.09 • n=5 Participants
|
70.0 Years
STANDARD_DEVIATION 9.13 • n=4 Participants
|
69.9 Years
STANDARD_DEVIATION 9.17 • n=21 Participants
|
|
Age, Customized
< 65 years old
|
308 Participants
n=5 Participants
|
333 Participants
n=7 Participants
|
311 Participants
n=5 Participants
|
315 Participants
n=4 Participants
|
1267 Participants
n=21 Participants
|
|
Age, Customized
65-80 years old
|
664 Participants
n=5 Participants
|
660 Participants
n=7 Participants
|
662 Participants
n=5 Participants
|
657 Participants
n=4 Participants
|
2643 Participants
n=21 Participants
|
|
Age, Customized
>=80
|
181 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
182 Participants
n=4 Participants
|
704 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
357 Participants
n=5 Participants
|
313 Participants
n=7 Participants
|
339 Participants
n=5 Participants
|
328 Participants
n=4 Participants
|
1337 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
796 Participants
n=5 Participants
|
840 Participants
n=7 Participants
|
815 Participants
n=5 Participants
|
826 Participants
n=4 Participants
|
3277 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
114 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
483 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1037 Participants
n=5 Participants
|
1020 Participants
n=7 Participants
|
1027 Participants
n=5 Participants
|
1023 Participants
n=4 Participants
|
4107 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
1039 Participants
n=5 Participants
|
1058 Participants
n=7 Participants
|
1043 Participants
n=5 Participants
|
1044 Participants
n=4 Participants
|
4184 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
140 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
47 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
157 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Approximately 6 monthsPopulation: Participants treated with Apixaban or VKA. Assessment is only for the Apixaban and VKA interventions.
Time to first ISTH major or CRNM bleeding during the 6-month period of treatment with Apixaban or VKA. N is the number of participants treated with Apixaban or VKA. n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with major or CRNM bleeding divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
Outcome measures
| Measure |
Apixaban
n=2290 Participants
5 mg or 2.5 mg Apixaban tablets orally twice per day with concomitant P2Y12 inhibitor therapy
|
Vitamin K Antagonist
n=2259 Participants
VKA tablets orally once daily with concomitant P2Y12 inhibitor therapy
|
|---|---|---|
|
The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period
|
24.66 Percentage per year
|
35.79 Percentage per year
|
PRIMARY outcome
Timeframe: Approximately 6 monthsPopulation: Participants treated with aspirin or placebo. Assessment is only for the Acetylsalicylic acid film coated tablet or Placebo matching Acetylsalicylic acid film coated tablet interventions.
Time to first ISTH major or CRNM bleeding during the treatment period of 6 months with aspirin or placebo. N is the number of participants with aspirin or placebo. n is the number of participants treated with aspirin or placebo with major or CRNM bleeding in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
Outcome measures
| Measure |
Apixaban
n=2277 Participants
5 mg or 2.5 mg Apixaban tablets orally twice per day with concomitant P2Y12 inhibitor therapy
|
Vitamin K Antagonist
n=2279 Participants
VKA tablets orally once daily with concomitant P2Y12 inhibitor therapy
|
|---|---|---|
|
The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period
|
40.51 Percentage per year
|
21.03 Percentage per year
|
SECONDARY outcome
Timeframe: Approximately 6 monthsPopulation: Participants treated with Apixaban or VKA. Assessment is only for the Apixaban or VKA interventions.
Time to first occurrence during the time the participants were treated with Apixaban or VKA. N is the number of participants treated with Apixaban or VKA. n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
Outcome measures
| Measure |
Apixaban
n=2290 Participants
5 mg or 2.5 mg Apixaban tablets orally twice per day with concomitant P2Y12 inhibitor therapy
|
Vitamin K Antagonist
n=2259 Participants
VKA tablets orally once daily with concomitant P2Y12 inhibitor therapy
|
|---|---|---|
|
Superiority on ISTH Major or CRNM Bleeding for Apixaban Versus VKA
|
24.66 Percentage per year
|
35.79 Percentage per year
|
SECONDARY outcome
Timeframe: Approximately 6 monthsPopulation: Participants randomized to Apixaban or VKA. Assessment is only for the Apixaban or VKA interventions.
Time to first all-cause death or all-cause hospitalization during the during the 6-month treatment period with Apixaban or VKA. N is the number of participants treated with Apixaban or VKA. n is the number of participants treated with Apixaban or VKA with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
Outcome measures
| Measure |
Apixaban
n=2306 Participants
5 mg or 2.5 mg Apixaban tablets orally twice per day with concomitant P2Y12 inhibitor therapy
|
Vitamin K Antagonist
n=2308 Participants
VKA tablets orally once daily with concomitant P2Y12 inhibitor therapy
|
|---|---|---|
|
The Rate of All-cause Death or All-cause Rehospitalization With Apixaban Versus VKA
|
57.24 Percentage per year
|
69.19 Percentage per year
|
SECONDARY outcome
Timeframe: Approximately 6 monthsPopulation: Participants randomized to aspirin or placebo. Assessment is only for the Acetylsalicylic acid film coated tablet or Placebo matching Acetylsalicylic acid film coated tablet interventions.
Time to first all-cause death or all-cause hospitalization during the 6-month period of treatment with aspirin or placebo. N is the number of participants treated with aspirin or placebo. n is the number of participants treated with aspirin or placebo with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
Outcome measures
| Measure |
Apixaban
n=2307 Participants
5 mg or 2.5 mg Apixaban tablets orally twice per day with concomitant P2Y12 inhibitor therapy
|
Vitamin K Antagonist
n=2307 Participants
VKA tablets orally once daily with concomitant P2Y12 inhibitor therapy
|
|---|---|---|
|
The Rate of All-cause Death or All-cause Rehospitalization With Aspirn Versus no Aspirin
|
65.72 Percentage per year
|
60.56 Percentage per year
|
SECONDARY outcome
Timeframe: Approximately 6 monthsPopulation: Participants randomized to Apixaban or VKA. Assessment is only for the Apixaban or VKA interventions.
Time to first occurrence during the 6-month treatment period with Apixaban or VKA. N is the number of participants treated with Apixaban or VKA. n is the number of participants treated with Apixaban or VKA with death or ischemic events in each treatment group during the during the 6-month period of treatment. Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
Outcome measures
| Measure |
Apixaban
n=2306 Participants
5 mg or 2.5 mg Apixaban tablets orally twice per day with concomitant P2Y12 inhibitor therapy
|
Vitamin K Antagonist
n=2308 Participants
VKA tablets orally once daily with concomitant P2Y12 inhibitor therapy
|
|---|---|---|
|
The Rate of the Composite Endpoint of Death or Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Apixaban Versus VKA
|
15.85 Percentage per year
|
17.17 Percentage per year
|
SECONDARY outcome
Timeframe: Approximately 6 monthsPopulation: Participants randomized to aspirin or placebo. Assessment is only for the Acetylsalicylic acid film coated tablet or Placebo matching Acetylsalicylic acid film coated tablet interventions.
Time to first death or ischenic event during the 6-month treatment period with aspirin or placebo. N is the number of participants treated with aspirin or placebo. n is the number of participants treated with aspirin or placebo with death or ischemic events in each treatment group during the 6-month treatment period. Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
Outcome measures
| Measure |
Apixaban
n=2307 Participants
5 mg or 2.5 mg Apixaban tablets orally twice per day with concomitant P2Y12 inhibitor therapy
|
Vitamin K Antagonist
n=2307 Participants
VKA tablets orally once daily with concomitant P2Y12 inhibitor therapy
|
|---|---|---|
|
The Composite Endpoints of Death and Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Aspirin Versus no Aspirin
|
15.28 Percentage per year
|
17.73 Percentage per year
|
Adverse Events
Apixaban With Acetylsalicylic Acid Film Coated Tablet
Serious events: 53 serious events
Other events: 35 other events
Deaths: 42 deaths
Apixaban With Placebo Matching Acetylsalicylic Acid
Serious events: 50 serious events
Other events: 21 other events
Deaths: 46 deaths
Vitamin K Antagonist (VKA) With Acetylsalicylic Acid
Serious events: 52 serious events
Other events: 33 other events
Deaths: 38 deaths
VKA With Placebo Matching Acetylsalicylic Acid
Serious events: 55 serious events
Other events: 18 other events
Deaths: 42 deaths
APIXABAN ONLY
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VKA ONLY
Serious events: 3 serious events
Other events: 1 other events
Deaths: 3 deaths
ACETYLSALICLIC ACID ONLY
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PLACEBO MATCHING ACETYLSALICLIC ACID ONLY
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Apixaban With Acetylsalicylic Acid Film Coated Tablet
n=1145 participants at risk
5 mg or 2.5 mg Apixaban tablets orally twice per day with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
|
Apixaban With Placebo Matching Acetylsalicylic Acid
n=1143 participants at risk
5 mg or 2.5 mg Apixaban tablets orally twice per day with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
|
Vitamin K Antagonist (VKA) With Acetylsalicylic Acid
n=1123 participants at risk
VKA tablets orally once daily with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
|
VKA With Placebo Matching Acetylsalicylic Acid
n=1126 participants at risk
VKA tablets orally once daily with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
|
APIXABAN ONLY
n=2 participants at risk
Only Apixaban intervention received: 5 mg or 2.5 mg Apixaban tablets orally twice per day
|
VKA ONLY
n=10 participants at risk
Only VKA intervention received: VKA tablets orally once daily
|
ACETYLSALICLIC ACID ONLY
n=9 participants at risk
Only acetylsalicylic acid intervention received: 81 mg Acetylsalicylic acid film coated tablet orally once daily
|
PLACEBO MATCHING ACETYLSALICLIC ACID ONLY
n=10 participants at risk
Only placebo matching acetylsalicylic acid intervention received: placebo matching Acetylsalicylic acid film coated tablet orally once daily
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Multimorbidity
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.26%
3/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.53%
6/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.27%
3/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Cardiac disorders
Angina unstable
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Cardiac disorders
Atrial flutter
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Cardiac disorders
Cardiac arrest
|
0.17%
2/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.26%
3/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.27%
3/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.27%
3/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Cardiac disorders
Cardiac failure
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.79%
9/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.45%
5/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.27%
3/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
10.0%
1/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Cardiac disorders
Cardiac failure acute
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.17%
2/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.27%
3/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.27%
3/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Cardiac disorders
Cardiogenic shock
|
0.17%
2/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.17%
2/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.18%
2/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.18%
2/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Cardiac disorders
Cardiomyopathy
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Cardiac disorders
Coronary artery disease
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Cardiac disorders
Myocardial infarction
|
0.35%
4/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.44%
5/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.45%
5/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.18%
2/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.18%
2/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
General disorders
Cardiac death
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
General disorders
Death
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
General disorders
Sudden cardiac death
|
0.17%
2/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.17%
2/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
General disorders
Sudden death
|
0.44%
5/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.26%
3/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.18%
2/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Hepatobiliary disorders
Jaundice
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Infections and infestations
Meningoencephalitis bacterial
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Infections and infestations
Pneumonia
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.18%
2/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Infections and infestations
Sepsis
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.17%
2/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.27%
3/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Infections and infestations
Septic shock
|
0.26%
3/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.18%
2/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.36%
4/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.17%
2/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.45%
5/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip squamous cell carcinoma
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.18%
2/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer stage IV
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Nervous system disorders
Brain injury
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.18%
2/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
10.0%
1/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.18%
2/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.27%
3/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Nervous system disorders
Status epilepticus
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.17%
2/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Vascular disorders
Hypotension
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Vascular disorders
Peripheral ischaemia
|
0.09%
1/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
10.0%
1/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Vascular disorders
Shock
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
Other adverse events
| Measure |
Apixaban With Acetylsalicylic Acid Film Coated Tablet
n=1145 participants at risk
5 mg or 2.5 mg Apixaban tablets orally twice per day with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
|
Apixaban With Placebo Matching Acetylsalicylic Acid
n=1143 participants at risk
5 mg or 2.5 mg Apixaban tablets orally twice per day with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
|
Vitamin K Antagonist (VKA) With Acetylsalicylic Acid
n=1123 participants at risk
VKA tablets orally once daily with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
|
VKA With Placebo Matching Acetylsalicylic Acid
n=1126 participants at risk
VKA tablets orally once daily with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
|
APIXABAN ONLY
n=2 participants at risk
Only Apixaban intervention received: 5 mg or 2.5 mg Apixaban tablets orally twice per day
|
VKA ONLY
n=10 participants at risk
Only VKA intervention received: VKA tablets orally once daily
|
ACETYLSALICLIC ACID ONLY
n=9 participants at risk
Only acetylsalicylic acid intervention received: 81 mg Acetylsalicylic acid film coated tablet orally once daily
|
PLACEBO MATCHING ACETYLSALICLIC ACID ONLY
n=10 participants at risk
Only placebo matching acetylsalicylic acid intervention received: placebo matching Acetylsalicylic acid film coated tablet orally once daily
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
16/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.26%
3/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.89%
10/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.53%
6/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
11.1%
1/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Cardiac disorders
Cardiac failure
|
0.70%
8/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.70%
8/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.80%
9/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.44%
5/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
11.1%
1/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
General disorders
Puncture site reaction
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
11.1%
1/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Infections and infestations
Pneumonia
|
0.44%
5/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.18%
2/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.18%
2/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
11.1%
1/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
11.1%
1/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.79%
9/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.26%
3/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.45%
5/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.18%
2/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
11.1%
1/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Renal and urinary disorders
Haematuria
|
0.17%
2/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.26%
3/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.45%
5/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.27%
3/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
10.0%
1/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
|
Vascular disorders
Haematoma
|
0.35%
4/1145 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.26%
3/1143 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.53%
6/1123 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.09%
1/1126 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/2 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
11.1%
1/9 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
0.00%
0/10 • Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email:
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60