Trial Outcomes & Findings for Trial to Assess the Safety and Effects of Vorapaxar in Japanese Subjects With Acute Coronary Syndrome (P04772; MK-5348-016) (NCT NCT00684203)
NCT ID: NCT00684203
Last Updated: 2017-05-05
Results Overview
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.
COMPLETED
PHASE2
120 participants
Up to Day 60
2017-05-05
Participant Flow
Of 120 participants enrolled and randomized to treatment, 117 participants were treated with study drug. 92 participants underwent percutaneous coronary intervention (PCI) and 25 did not.
Participant milestones
| Measure |
Vorapaxar 20 mg (PCI)
Vorapaxar 20 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg (PCI)
Vorapaxar 40 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo (PCI)
Placebo as loading dose is administered as the initial dose to PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 20 mg (Non-PCI)
Vorapaxar 20 mg as a loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration 60 days).
|
Vorapaxar 40 mg (Non-PCI)
Vorapaxar 40 mg as loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo (Non-PCI)
Placebo as loading dose is administered as the initial dose to non-PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
31
|
21
|
6
|
17
|
2
|
|
Overall Study
COMPLETED
|
31
|
23
|
12
|
6
|
17
|
2
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
9
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Vorapaxar 20 mg (PCI)
Vorapaxar 20 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg (PCI)
Vorapaxar 40 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo (PCI)
Placebo as loading dose is administered as the initial dose to PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 20 mg (Non-PCI)
Vorapaxar 20 mg as a loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration 60 days).
|
Vorapaxar 40 mg (Non-PCI)
Vorapaxar 40 mg as loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo (Non-PCI)
Placebo as loading dose is administered as the initial dose to non-PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
4
|
8
|
0
|
0
|
0
|
|
Overall Study
Protocol-defined clinical event
|
3
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
1
|
0
|
0
|
0
|
|
Overall Study
Did not meet protocol eligibility
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Trial to Assess the Safety and Effects of Vorapaxar in Japanese Subjects With Acute Coronary Syndrome (P04772; MK-5348-016)
Baseline characteristics by cohort
| Measure |
Vorapaxar 20 mg (PCI)
n=40 Participants
Vorapaxar 20 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg (PCI)
n=31 Participants
Vorapaxar 40 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo (PCI)
n=21 Participants
Placebo as loading dose is administered as the initial dose to PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 20 mg (Non-PCI)
n=6 Participants
Vorapaxar 20 mg as a loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration 60 days).
|
Vorapaxar 40 mg (Non-PCI)
n=17 Participants
Vorapaxar 40 mg as loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo (Non-PCI)
n=2 Participants
Placebo as loading dose is administered as the initial dose to non-PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.3 Years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
64.5 Years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
65.0 Years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
59.0 Years
STANDARD_DEVIATION 14.3 • n=4 Participants
|
64.1 Years
STANDARD_DEVIATION 13.6 • n=21 Participants
|
66.5 Years
STANDARD_DEVIATION 3.5 • n=8 Participants
|
64.2 Years
STANDARD_DEVIATION 10.3 • n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
88 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to Day 60Population: The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI.
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.
Outcome measures
| Measure |
Vorapaxar 20 mg Loading Dose PCI
n=40 Participants
Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg Loading Dose PCI
n=31 Participants
Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
n=21 Participants
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg/2.5 mg PCI
Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
|---|---|---|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs) Who Underwent Percutaneous Coronary Interventions (PCI)
|
40 Participants
|
30 Participants
|
21 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 121Population: The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with Non-Major MACE data available.
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. MACE events were defined as nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization performed ≥ 30 days after administration of the loading dose (Day 1). All MACE events were excluded from this analysis. Analysis of data was by loading/maintenance dose group.
Outcome measures
| Measure |
Vorapaxar 20 mg Loading Dose PCI
n=21 Participants
Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg Loading Dose PCI
n=19 Participants
Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
n=16 Participants
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg/2.5 mg PCI
n=15 Participants
Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
n=21 Participants
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
|---|---|---|---|---|---|
|
Number of Participants Experiencing Non-Major Adverse Cardiac Events (MACE) Who Underwent PCI
|
21 Participants
|
19 Participants
|
16 Participants
|
14 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Up to Day 60Population: The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with TIMI bleeding data available.
Major TIMI bleeding was defined as any intracranial bleeding (excluding microhemorrhages \<10 mm evident only on gradient-echo magnetic resonance imaging \[MRI\]), clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in hemoglobin drop of 3 to \<5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI bleeding or Minor TIMI bleeding. Analysis of data was by maintenance dose group.
Outcome measures
| Measure |
Vorapaxar 20 mg Loading Dose PCI
n=37 Participants
Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg Loading Dose PCI
n=33 Participants
Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
n=21 Participants
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg/2.5 mg PCI
Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
|---|---|---|---|---|---|
|
Number of Participants With Major, Minor, and Non-Thrombolysis in Myocardial Infarction Cooperative Group (TIMI) Bleeding Events Among Participants Who Underwent PCI
Major TIMI Bleeding Events
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Major, Minor, and Non-Thrombolysis in Myocardial Infarction Cooperative Group (TIMI) Bleeding Events Among Participants Who Underwent PCI
Minor TIMI Bleeding Events
|
5 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Major, Minor, and Non-Thrombolysis in Myocardial Infarction Cooperative Group (TIMI) Bleeding Events Among Participants Who Underwent PCI
Non-TIMI Bleeding Events
|
22 Participants
|
17 Participants
|
11 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 30, Day 60, Day 74, Day 90, Day 121Population: The population consisted of all enrolled participants who received at least 1 dose of study drug and underwent PCI with inhibition of platelet aggregation data available.
Blood samples were collected from participants at Baseline and Days 30, 60, 74, 90, and 121 to determine the extent of inhibition of platelet aggregation induced by thrombin-receptor agonist peptide (TRAP). Analysis of data was by maintenance dose group.
Outcome measures
| Measure |
Vorapaxar 20 mg Loading Dose PCI
n=5 Participants
Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg Loading Dose PCI
n=4 Participants
Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
n=3 Participants
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg/2.5 mg PCI
Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
|---|---|---|---|---|---|
|
Number of Participants Who Underwent PCI With Inhibition of Platelet Aggregation By Study Visit
Baseline
|
5 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants Who Underwent PCI With Inhibition of Platelet Aggregation By Study Visit
Day 30
|
5 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants Who Underwent PCI With Inhibition of Platelet Aggregation By Study Visit
Day 60
|
3 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Who Underwent PCI With Inhibition of Platelet Aggregation By Study Visit
Day 74 (follow-up period)
|
5 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants Who Underwent PCI With Inhibition of Platelet Aggregation By Study Visit
Day 90 (follow-up period)
|
5 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants Who Underwent PCI With Inhibition of Platelet Aggregation By Study Visit
Day 121 (follow-up period)
|
5 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 30, Day 60Population: The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with hs-CRP data available.
Participant blood samples were collected at Baseline and on Days 30 and 60 to evaluate the median level of hs-CRP. hs-CRP is a protein marker in the blood associated with inflammation with higher values indicating a greater degree of inflammation. Analysis of data was by maintenance dose group.
Outcome measures
| Measure |
Vorapaxar 20 mg Loading Dose PCI
n=37 Participants
Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg Loading Dose PCI
n=34 Participants
Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
n=21 Participants
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg/2.5 mg PCI
Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
|---|---|---|---|---|---|
|
Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels Among Participants Who Underwent PCI By Study Visit
Baseline (n=37, 34, 21)
|
1.30 mg/L
Interval 0.54 to 4.5
|
2.00 mg/L
Interval 0.61 to 8.36
|
1.78 mg/L
Interval 0.66 to 4.5
|
—
|
—
|
|
Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels Among Participants Who Underwent PCI By Study Visit
Day 30 (n=35, 34, 21)
|
1.28 mg/L
Interval 0.43 to 7.9
|
1.01 mg/L
Interval 0.7 to 5.62
|
2.99 mg/L
Interval 1.14 to 9.4
|
—
|
—
|
|
Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels Among Participants Who Underwent PCI By Study Visit
Day 60 (n=30, 25, 13)
|
1.20 mg/L
Interval 0.39 to 3.0
|
0.79 mg/L
Interval 0.44 to 2.02
|
1.27 mg/L
Interval 0.61 to 4.88
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 30, Day 60Population: The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with CD40 ligand data available.
Participant blood samples were collected at Baseline and Days 30 and 60 to evaluate the mean level of CD40 ligand present. CD40 ligand is a protein primarily found on activated T-cells, with higher levels indicating better immunological health. Analysis of data was by maintenance dose group.
Outcome measures
| Measure |
Vorapaxar 20 mg Loading Dose PCI
n=37 Participants
Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg Loading Dose PCI
n=34 Participants
Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
n=21 Participants
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg/2.5 mg PCI
Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
|---|---|---|---|---|---|
|
Mean CD40 Ligand Levels Among Participants Who Underwent PCI
Baseline (n=37, 34, 21)
|
5.6 ng/mL
Standard Error 0.56 • Interval 0.54 to 4.5
|
6.9 ng/mL
Standard Error 0.60 • Interval 0.61 to 8.36
|
4.8 ng/mL
Standard Error 0.79 • Interval 0.66 to 4.5
|
—
|
—
|
|
Mean CD40 Ligand Levels Among Participants Who Underwent PCI
Day 30 (n=35, 34, 31)
|
5.9 ng/mL
Standard Error 0.52 • Interval 0.43 to 7.9
|
5.9 ng/mL
Standard Error 0.63 • Interval 0.7 to 5.62
|
6.2 ng/mL
Standard Error 0.73 • Interval 1.14 to 9.4
|
—
|
—
|
|
Mean CD40 Ligand Levels Among Participants Who Underwent PCI
Day 60 (n=30, 25, 13)
|
5.6 ng/mL
Standard Error 0.55 • Interval 0.39 to 3.0
|
5.4 ng/mL
Standard Error 0.58 • Interval 0.44 to 2.02
|
5.7 ng/mL
Standard Error 1.21 • Interval 0.61 to 4.88
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 30, Day 60Population: The population included all enrolled participants that received at least 1 dose of study drug and underwent PCI with membrane-bound P-selectin data available.
Participant blood samples were collected at Baseline and Days 30 and 60 to evaluate the mean level of membrane-bound P-selectin. Membrane-bound P-selectin was measured using flow cytometry and a monoclonal antibody to P-selectin. Intensity levels are reported in arbitrary units 0 (dark) to 1023 (bright). Higher values correspond to greater membrane-bound P-Selectin levels. Analysis of data was by maintenance dose group.
Outcome measures
| Measure |
Vorapaxar 20 mg Loading Dose PCI
n=4 Participants
Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg Loading Dose PCI
n=4 Participants
Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
n=3 Participants
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg/2.5 mg PCI
Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
|---|---|---|---|---|---|
|
Mean Membrane-Bound P-Selectin Levels Among Participants Who Underwent PCI
Baseline (n=4, 4, 3)
|
24.8 Arbitrary Units
Standard Error 2.86 • Interval 0.54 to 4.5
|
16.5 Arbitrary Units
Standard Error 0.83 • Interval 0.61 to 8.36
|
15.9 Arbitrary Units
Standard Error 1.25 • Interval 0.66 to 4.5
|
—
|
—
|
|
Mean Membrane-Bound P-Selectin Levels Among Participants Who Underwent PCI
Day 30 (n=3, 4, 3)
|
20.6 Arbitrary Units
Standard Error 1.76 • Interval 0.43 to 7.9
|
16.4 Arbitrary Units
Standard Error 0.85 • Interval 0.7 to 5.62
|
18.8 Arbitrary Units
Standard Error 0.91 • Interval 1.14 to 9.4
|
—
|
—
|
|
Mean Membrane-Bound P-Selectin Levels Among Participants Who Underwent PCI
Day 60 (n=2, 3, 1)
|
25.0 Arbitrary Units
Standard Error 2.80 • Interval 0.39 to 3.0
|
14.9 Arbitrary Units
Standard Error 0.62 • Interval 0.44 to 2.02
|
19.4 Arbitrary Units
Standard Error NA • Interval 0.61 to 4.88
SE not calculable since n=1.
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 121Population: The population included all participants who received at least 1 dose of study drug, underwent PCI, and had bleeding event data.
Clinically important bleeding events were defined as intracranial hemorrhage, bleeding requiring hospitalization, or TIMI major bleeding. Analysis of data was by loading/maintenance dose group.
Outcome measures
| Measure |
Vorapaxar 20 mg Loading Dose PCI
n=21 Participants
Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg Loading Dose PCI
n=19 Participants
Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
n=16 Participants
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg/2.5 mg PCI
n=15 Participants
Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
n=21 Participants
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
|---|---|---|---|---|---|
|
Number of Participants Who Underwent PCI With Clinically Important Bleeding Events During Treatment and After Hospital Discharge
Treatment Phase
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Underwent PCI With Clinically Important Bleeding Events During Treatment and After Hospital Discharge
Post-Hospital Discharge
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 60Population: The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had TIMI bleeding data available.
Major TIMI bleeding was defined as any intracranial bleeding (excluding microhemorrhages \<10 mm evident only on gradient-echo MRI), clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in hemoglobin drop of 3 to \<5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI bleeding or Minor TIMI bleeding. Analysis of data was by loading dose group.
Outcome measures
| Measure |
Vorapaxar 20 mg Loading Dose PCI
n=6 Participants
Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg Loading Dose PCI
n=17 Participants
Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
n=2 Participants
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg/2.5 mg PCI
Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
|---|---|---|---|---|---|
|
Number of Participants With Major, Minor, and Non-TIMI Bleeding Events Among Participants Who Did Not Undergo PCI
Major TIMI Events
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Major, Minor, and Non-TIMI Bleeding Events Among Participants Who Did Not Undergo PCI
Minor TIMI Events
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Major, Minor, and Non-TIMI Bleeding Events Among Participants Who Did Not Undergo PCI
Non-TIMI Bleeding Events
|
1 Participants
|
8 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 121Population: The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had non-MACE AE data available.
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. MACE events were defined as nonfatal MI, nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization performed ≥ 30 days after administration of the loading dose (Day 1). All MACE events were excluded from this analysis. Analysis of data was by loading dose group.
Outcome measures
| Measure |
Vorapaxar 20 mg Loading Dose PCI
n=6 Participants
Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg Loading Dose PCI
n=17 Participants
Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
n=2 Participants
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg/2.5 mg PCI
Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
|---|---|---|---|---|---|
|
Number of Participants Experiencing Non-MACE AEs Among Participants Who Did Not Undergo PCI
|
6 Participants
|
15 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 10 Hours Post-CABGPopulation: Evaluation of the bleeding events associated with CABG occurring after Vorapaxar treatment was not analyzed since only three participants in the non-PCI cohort underwent CABG in this study.
Bleeding events were evaluated up to 10 hours post-CABG among participants who did not undergo PCI.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Day 60Population: The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had transfusion data available.
Bleeding events were evaluated among participants that did not undergo PCI to determine the number of participants that required blood transfusion. Analysis of data was by loading dose group.
Outcome measures
| Measure |
Vorapaxar 20 mg Loading Dose PCI
n=6 Participants
Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg Loading Dose PCI
n=17 Participants
Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
n=2 Participants
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg/2.5 mg PCI
Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
|---|---|---|---|---|---|
|
Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Transfusion
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 30Population: The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had hospitalization data available.
Bleeding events were evaluated among participants that did not undergo PCI to determine the number of participants who required a subsequent hospitalization. Analysis of data was by loading dose group.
Outcome measures
| Measure |
Vorapaxar 20 mg Loading Dose PCI
n=6 Participants
Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg Loading Dose PCI
n=17 Participants
Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
n=2 Participants
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg/2.5 mg PCI
Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
|---|---|---|---|---|---|
|
Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Subsequent Hospitalization
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Up To Day 60Population: The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had hs-CRP data available.
Participant blood samples were collected at baseline and at the time of hospital discharge to determine the median serum level of hs-CRP. Analysis of data was by loading dose group.
Outcome measures
| Measure |
Vorapaxar 20 mg Loading Dose PCI
n=6 Participants
Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg Loading Dose PCI
n=17 Participants
Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
n=2 Participants
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg/2.5 mg PCI
Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
|---|---|---|---|---|---|
|
Median Hs-CRP Levels Among Participants Who Did Not Undergo PCI
Baseline
|
2.57 mg/L
Standard Deviation 5.70
|
1.05 mg/L
Standard Deviation 2.23
|
6.94 mg/L
Standard Deviation 12.01
|
—
|
—
|
|
Median Hs-CRP Levels Among Participants Who Did Not Undergo PCI
Time of Hospital Discharge
|
3.56 mg/L
Standard Deviation 10.12
|
2.65 mg/L
Standard Deviation 5.00
|
3.96 mg/L
Standard Deviation 0.91
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Up To Day 60Population: The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had CD40 ligand data available.
Participant blood samples were collected at baseline and at the time of hospital discharge to determine the mean serum level of CD40 ligand. Analysis of data was by loading dose group.
Outcome measures
| Measure |
Vorapaxar 20 mg Loading Dose PCI
n=6 Participants
Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg Loading Dose PCI
n=17 Participants
Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
n=2 Participants
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg/2.5 mg PCI
Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
|---|---|---|---|---|---|
|
Mean CD40 Ligand Levels Among Participants Who Did Not Undergo PCI
Time of Hospital Discharge
|
10.1 ng/mL
Standard Error 2.86
|
7.1 ng/mL
Standard Error 0.83
|
12.9 ng/mL
Standard Error 4.64
|
—
|
—
|
|
Mean CD40 Ligand Levels Among Participants Who Did Not Undergo PCI
Baseline
|
8.4 ng/mL
Standard Error 1.10
|
4.6 ng/mL
Standard Error 0.79
|
11.1 ng/mL
Standard Error 4.06
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Up To Day 60Population: The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had bleeding event data available.
Clinically important bleeding events were defined as intracranial hemorrhage, bleeding requiring blood transfusion, bleeding requiring hospitalization, and TIMI major bleeding. Analysis of data was by loading dose group.
Outcome measures
| Measure |
Vorapaxar 20 mg Loading Dose PCI
n=6 Participants
Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg Loading Dose PCI
n=17 Participants
Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
n=2 Participants
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg/2.5 mg PCI
Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo PCI
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
|---|---|---|---|---|---|
|
Number of Participants Who Did Not Undergo PCI That Had Clinically Important Bleeding Events
Intracranial hemorrhage
|
0 Participants
1.10
|
1 Participants
0.79
|
0 Participants
4.06
|
—
|
—
|
|
Number of Participants Who Did Not Undergo PCI That Had Clinically Important Bleeding Events
Bleeding requiring transfusion
|
1 Participants
2.86
|
2 Participants
0.83
|
0 Participants
4.64
|
—
|
—
|
|
Number of Participants Who Did Not Undergo PCI That Had Clinically Important Bleeding Events
Bleeding requiring hospitalization
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Who Did Not Undergo PCI That Had Clinically Important Bleeding Events
Major TIMI bleeding
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
Adverse Events
Vorapaxar 20 mg/1 mg
Vorapaxar 20 mg/2.5 mg
Vorapaxar 40 mg/1 mg
Vorapaxar 40 mg/2.5 mg
Placebo/Placebo
Serious adverse events
| Measure |
Vorapaxar 20 mg/1 mg
n=25 participants at risk
Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 20 mg/2.5 mg
n=24 participants at risk
Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg/1 mg
n=22 participants at risk
Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg/2.5 mg
n=26 participants at risk
Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo
n=23 participants at risk
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
4.0%
1/25 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Cardiac disorders
Cardiac Tamponade
|
4.0%
1/25 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Cardiac disorders
Supraventricular Extrasystoles
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Cardiac disorders
Ventricle Rupture
|
4.0%
1/25 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Ear and labyrinth disorders
Sudden Hearing Loss
|
4.0%
1/25 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.3%
1/23 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Gastrointestinal disorders
Malaena
|
4.0%
1/25 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
General disorders
Chest Discomfort
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.2%
1/24 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Infections and infestations
Bronchitis
|
4.0%
1/25 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.5%
1/22 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.3%
1/23 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.3%
1/23 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.5%
1/22 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
4.0%
1/25 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.3%
1/23 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Investigations
Blood Glucose Increased
|
4.0%
1/25 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.2%
1/24 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Adenoma
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.2%
1/24 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.2%
1/24 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Nervous system disorders
Loss of Consciousness
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.3%
1/23 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.3%
1/23 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Vascular disorders
Arteriosclerosis Obliterans
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.3%
1/23 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
Other adverse events
| Measure |
Vorapaxar 20 mg/1 mg
n=25 participants at risk
Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 20 mg/2.5 mg
n=24 participants at risk
Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg/1 mg
n=22 participants at risk
Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Vorapaxar 40 mg/2.5 mg
n=26 participants at risk
Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
Placebo/Placebo
n=23 participants at risk
Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.0%
2/25 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.2%
1/24 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
7.7%
2/26 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.5%
1/22 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
7.7%
2/26 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
12.5%
3/24 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.3%
1/23 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Cardiac disorders
Myocardial Infarction
|
12.0%
3/25 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
12.5%
3/24 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
22.7%
5/22 • Number of events 5 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
7.7%
2/26 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
39.1%
9/23 • Number of events 10 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
18.2%
4/22 • Number of events 4 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.7%
2/23 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Gastrointestinal disorders
Abdominal Distention
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
7.7%
2/26 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Gastrointestinal disorders
Constipation
|
24.0%
6/25 • Number of events 7 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
29.2%
7/24 • Number of events 8 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
13.6%
3/22 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
15.4%
4/26 • Number of events 5 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
26.1%
6/23 • Number of events 7 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.0%
4/25 • Number of events 5 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.3%
2/24 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.7%
2/23 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.5%
1/22 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
7.7%
2/26 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
9.1%
2/22 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.3%
2/24 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.5%
1/22 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.7%
2/23 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.7%
2/23 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.3%
2/24 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.5%
1/22 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.3%
1/23 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
General disorders
Chest Discomfort
|
12.0%
3/25 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
12.5%
3/24 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
13.6%
3/22 • Number of events 4 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
15.4%
4/26 • Number of events 4 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.7%
2/23 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
General disorders
Chest Pain
|
8.0%
2/25 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
12.5%
3/24 • Number of events 9 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.5%
1/22 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
7.7%
2/26 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.7%
2/23 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
General disorders
Oedema Peripheral
|
8.0%
2/25 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.5%
1/22 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
General disorders
Puncture Site Haemorrhage
|
8.0%
2/25 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.5%
1/22 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.7%
2/23 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
General disorders
Puncture Site Pain
|
4.0%
1/25 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
18.2%
4/22 • Number of events 5 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.3%
1/23 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
General disorders
Pyrexia
|
24.0%
6/25 • Number of events 7 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
12.5%
3/24 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
13.6%
3/22 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
13.0%
3/23 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
General disorders
Venipuncture Site Swelling
|
8.0%
2/25 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
8.0%
2/25 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.2%
1/24 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
9.1%
2/22 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
19.2%
5/26 • Number of events 5 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
13.0%
3/23 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Infections and infestations
Gingival Abscess
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.7%
2/23 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Infections and infestations
Nasopharyngitis
|
16.0%
4/25 • Number of events 5 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
16.7%
4/24 • Number of events 4 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
22.7%
5/22 • Number of events 5 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
7.7%
2/26 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
13.0%
3/23 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
12.0%
3/25 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.3%
2/24 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
9.1%
2/22 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
7.7%
2/26 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
17.4%
4/23 • Number of events 5 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
4.0%
1/25 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
12.5%
3/24 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
13.6%
3/22 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
11.5%
3/26 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
17.4%
4/23 • Number of events 4 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.3%
2/24 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.7%
2/23 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.7%
2/23 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
4.0%
1/25 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.7%
2/23 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
13.6%
3/22 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
7.7%
2/26 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.3%
1/23 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
7.7%
2/26 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Investigations
Blood Pressure Decreased
|
8.0%
2/25 • Number of events 5 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.2%
1/24 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
7.7%
2/26 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.3%
1/23 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Investigations
Blood Triglycerides Increased
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
12.5%
3/24 • Number of events 4 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Investigations
Blood Urine Present
|
16.0%
4/25 • Number of events 5 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.2%
1/24 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
9.1%
2/22 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
11.5%
3/26 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.7%
2/23 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.2%
1/24 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
7.7%
2/26 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.7%
2/23 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Investigations
Haemoglobin Decreased
|
4.0%
1/25 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
12.5%
3/24 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
9.1%
2/22 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.7%
2/23 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Investigations
Occult Blood
|
16.0%
4/25 • Number of events 4 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.3%
2/24 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.5%
1/22 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Investigations
Occult Blood Positive
|
48.0%
12/25 • Number of events 13 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
33.3%
8/24 • Number of events 8 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
45.5%
10/22 • Number of events 10 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
26.9%
7/26 • Number of events 9 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
43.5%
10/23 • Number of events 10 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Investigations
Protein Urine Present
|
8.0%
2/25 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.2%
1/24 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
9.1%
2/22 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.2%
1/24 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
7.7%
2/26 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.7%
2/23 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Metabolism and nutrition disorders
Hyperchlesterolaemia
|
4.0%
1/25 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
13.0%
3/23 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.0%
1/25 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
7.7%
2/26 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.3%
1/23 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.0%
2/25 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.2%
1/24 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
31.8%
7/22 • Number of events 8 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
11.5%
3/26 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
13.0%
3/23 • Number of events 4 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.2%
1/24 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
9.1%
2/22 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.3%
1/23 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
4.0%
1/25 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
12.5%
3/24 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.5%
1/22 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Nervous system disorders
Dizziness
|
8.0%
2/25 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.5%
1/22 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.3%
1/23 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Nervous system disorders
Dizziness Postural
|
4.0%
1/25 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.5%
1/22 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.7%
2/23 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Nervous system disorders
Headache
|
12.0%
3/25 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.2%
1/24 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
22.7%
5/22 • Number of events 5 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
11.5%
3/26 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
21.7%
5/23 • Number of events 5 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.2%
1/24 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
9.1%
2/22 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Psychiatric disorders
Insomnia
|
20.0%
5/25 • Number of events 5 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
12.5%
3/24 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
9.1%
2/22 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
26.9%
7/26 • Number of events 7 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
13.0%
3/23 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Psychiatric disorders
Restlessness
|
12.0%
3/25 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Renal and urinary disorders
Haematuria
|
8.0%
2/25 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.2%
1/24 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
13.0%
3/23 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.2%
1/24 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.5%
1/22 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.7%
2/23 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
2/25 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.5%
1/22 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.3%
1/23 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.0%
3/25 • Number of events 4 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
16.7%
4/24 • Number of events 5 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
15.4%
4/26 • Number of events 4 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.7%
2/23 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.0%
2/25 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.3%
1/23 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
9.1%
2/22 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.3%
1/23 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Cold Sweat
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.2%
1/24 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
9.1%
2/22 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
4.0%
1/25 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.3%
2/24 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
7.7%
2/26 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.0%
2/25 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.2%
1/24 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage Subcutaneous
|
4.0%
1/25 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.3%
2/24 • Number of events 3 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
18.2%
4/22 • Number of events 4 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
7.7%
2/26 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.0%
1/25 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
9.1%
2/22 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.3%
1/23 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
8.0%
2/25 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.3%
2/24 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.5%
1/22 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
7.7%
2/26 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.0%
2/25 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.3%
2/24 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.5%
1/22 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.7%
2/23 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
8.0%
2/25 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/22 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.0%
1/25 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
9.1%
2/22 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
4.3%
1/23 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Vascular disorders
Angiopathy
|
0.00%
0/25 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/24 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
9.1%
2/22 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/26 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
0.00%
0/23 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
|
Vascular disorders
Hypertension
|
8.0%
2/25 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.3%
2/24 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
22.7%
5/22 • Number of events 6 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
3.8%
1/26 • Number of events 1 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
8.7%
2/23 • Number of events 2 • Up to Day 121
As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Results disclosure agreements
- Principal investigator is a sponsor employee Prior approval by the Sponsor is required before the results obtained in the clinical study can be made public by the investigator (sub-investigator) in a publication or at a medical meeting.
- Publication restrictions are in place
Restriction type: OTHER