Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Patients With Acute Coronary Syndromes (The ATLAS ACS TIMI 46 Trial)
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)
Overall Status
Completed
CT.gov ID
NCT00402597
Collaborator
Bayer (Industry)
3,490
3
23
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety of rivaroxaban in patients with recent acute coronary syndrome (ACS) and to assess the ability of rivaroxaban to reduce the occurrence of death, myocardial infarction (heart attack), repeat myocardial infarctions, stroke, and ischemia (inadequate blood supply to a local area) in patients with recent ACS.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This is a randomized (patients will be assigned to study treatment by chance), double-blind (neither the patient nor the study doctor will know the identity of the assigned study treatment) study to evaluate the safety and efficacy of rivaroxaban (study drug) compared to placebo (a tablet identical in appearance to study drug but contains no active drug) in patients with acute coronary syndrome (ACS [a condition where blood flow in a blood vessel in the heart is restricted because of a blood clot]). Rivaroxaban is a drug that acts as a blood thinner and is being tested to see if it will be safe and effective in patients diagnosed ACS. The goal of this study is to identify the dose and dosing schedule (once-a-day or twice-a-day dosing) of rivaroxaban that will be safe and effective in preventing adverse cardiovascular outcomes such as death, myocardial infarctions (MI) including repeat myocardial infarction (reMI), stroke, or ischemia (inadequate blood supply to a local area) requiring revascularization (ie, the re-establishment of blood supply to a part or an organ) in patients with ACS who are receiving antiplatelet therapy (ie, aspirin alone or aspirin plus an approved thienopyridine, a type of drug such as clopidogrel that acts to inhibit the formation of blood clots). Approximately 3500 patients are planned to participate in the study for approximately 7 months. At study entry, all patients who are currently receiving treatment for ACS with antiplatelet therapy will be permitted to continue this therapy during the study. Patients will be enrolled and randomized to receive placebo, rivaroxaban administered as a once-daily dose, or rivaroxaban administered as a twice-daily dose at each dose level of rivaroxaban tested. Patients randomized at each dose level will continue to receive the same treatment for 6 months. Near the end of enrollment at the first dose level, available safety and efficacy data from patients will be assessed by an Operations Committee before enrolling and randomizing additional patients to the next higher dose level of rivaroxaban. Increasing dose levels of rivaroxaban are planned; however, progression to each higher dose level will be at the discretion of the Operations Committee. Patient safety will be monitored by evaluating adverse events reported, results from clinical laboratory tests, findings from electrocardiograms (ECGs) and vital signs measurements, findings from physical examinations, and the number of patients with protocol-defined major or minor bleeding, or bleeding requiring medical attention. All patients will take study drug or placebo tablets orally (by mouth) twice daily for 6 months starting at an initial total daily dose of 5 mg. Both once- and twice-daily dosing regimens will be tested at each rivaroxaban dose level planned.
Study Design
Study Type:
Interventional
Actual Enrollment
:
3490 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation and Dose-Confirmation Study to Evaluate the Safety and Efficacy of Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Subjects With Acute Coronary Syndromes
Study Start Date
:
Nov 1, 2006
Actual Primary Completion Date
:
Oct 1, 2008
Actual Study Completion Date
:
Oct 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 001 Rivaroxaban 1 rivaroxaban tablet twice daily for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level. |
Drug: Rivaroxaban
1 rivaroxaban tablet twice daily for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level.
|
| Experimental: 002 Rivaroxaban/Placebo 1 rivaroxaban tablet once daily (and 1 placebo tablet once daily) for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level. |
Drug: Rivaroxaban/Placebo
1 rivaroxaban tablet once daily (and 1 placebo tablet once daily) for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level.
|
| Placebo Comparator: 003 Placebo 1 placebo tablet twice daily for 6 months. |
Drug: Placebo
1 placebo tablet twice daily for 6 months.
|
Outcome Measures
Primary Outcome Measures
- Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (Primary Safety) [Day 1 to Day 210]
The number of patients with a first occurrence of a TIMI clinically significant bleeding event that occurred from the time of randomization to the time of the last patient contact. TIMI clinically significant bleeding events included TIMI minor bleeding events, TIMI major bleeding events, or any bleeding that required medical attention.
- The Composite Endpoint of All Cause Death, Myocardial Infarction (MI) (Including Repeat MI), Stroke (Ischemic, Hemorrhagic or Unknown), or Severe Recurrent Ischemia Requiring Revascularization (Primary Efficacy) [Day 1 to Day 210]
The number of patients who died due to any cause or had a first occurrence of MI (including repeat MI) or stroke (ischemic, hemorrhagic or unknown) or severe recurrent ischemia requiring revascularization from the time of randomization to the last date of patient contact.
Secondary Outcome Measures
- The Composite Endpoint of Death (All Cause), Myocardial Infarction (MI) (or Repeat MI), or Stroke [Day 1 to Day 210]
The number of patients who died due to any cause or had a first occurrence of MI (or repeat MI) or stroke from the time of randomization to the last date of patient contact.
- The Composite Endpoint of Cardiovascular Death, Myocardial Infarction (MI), or Stroke [Day 1 to Day 210]
The number of patients with the composite endpoint of cardiovascular death or MI or stroke that occurred from the time of randomization to the last date of patient contact.
- The Number of Deaths (All Cause) [Day 1 to Day 210]
The number of patients who died due to any cause from the time of randomization to the last date of patient contact.
- The Composite Endpoint of Death (All Cause), MI (or reMI), Stroke, Severe Recurrent Ischemia Requiring Revascularization, or Thrombolysis in Myocardial Infarction (TIMI) (Major or Minor Bleeding) to Assess the Net Clinical Benefit [Day 1 to Day 210]
The number of patients who died due to any cause or had a first occurrence of MI (or repeat MI), or stroke, or severe recurrent ischemia requiring revascularization, or TIMI (major or minor bleeding) from the time of randomization to the last date of patient contact to assess the net clinical benefit of rivaroxaban.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Have symptoms suggestive of ACS that lasted at least 10 minutes at rest occurring within 7 days of randomization
-
Have a diagnosis of ST-elevation myocardial infarction or non-ST elevation myocardial infarction/unstable angina (ie, chest pain or discomfort) (ST elevation is an abnormal finding from an ECG test) with at least 1 protocol-defined high risk feature
Exclusion Criteria:
-
Active bleeding or high risk of bleeding or intracranial hemorrhage (bleeding within the skull enclosing the brain)
-
Need for continued anticoagulant therapy
-
Significantly impaired renal (kidney) or hepatic (liver) function
-
Severe concomitant diseases such as cardiogenic shock (heart damage that results in insufficient blood supply to other parts or organs of the body), refractory ventricular arrhythmias (irregular contractions of the heart unresponsive to treatment), or any severe condition that would limit life expectancy of the patient to less than 6 months
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Bayer
Investigators
- Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00402597
Other Study ID Numbers:
- CR013417
- 39039039ACS2001
- NCT01151332
First Posted:
Nov 22, 2006
Last Update Posted:
Oct 4, 2012
Last Verified:
Sep 1, 2012
Keywords provided by ,
,
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | NCT00402597: Study 39039039ACS2001 (ATLAS ACS TIMI 46 Trial) was conducted at 297 centers in 27 countries between 17 November 2006 and 19 September 2008. A total of 3576 patients were screened for study and 3491 patients were randomly assigned to treatment. |
|---|---|
| Pre-assignment Detail | Of the 3576 patients screened for study, 85 patients were screening failures and 3491 patients were randomly assigned to treatment. All randomized patients were included in the intent-to-treat (ITT) analysis set and were eligible for efficacy analyses. Of the 3491 patients, 29 never took study drug, leaving 3462 patients valid for safety analysis. |
| Arm/Group Title | Placebo | Riva 5 mg Total Daily Dose (TDD) | Riva 10 mg TDD | Riva 15 mg TDD | Riva 20 mg TDD |
|---|---|---|---|---|---|
| Arm/Group Description | One placebo tablet twice daily for 6 months. | Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) | Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months. | Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months. | Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months. |
| Period Title: Overall Study | |||||
| STARTED | 1153 | 307 | 1046 | 353 | 603 |
| COMPLETED | 962 | 261 | 834 | 279 | 479 |
| NOT COMPLETED | 191 | 46 | 212 | 74 | 124 |
Baseline Characteristics
| Arm/Group Title | Placebo | Riva 5 mg Total Daily Dose (TDD) | Riva 10 mg TDD | Riva 15 mg TDD | Riva 20 mg TDD | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | One placebo tablet twice daily for 6 months. | Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) | Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months. | Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months. | Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months. | Total of all reporting groups |
| Overall Participants | 1153 | 307 | 1046 | 353 | 603 | 3462 |
| Age (Count of Participants) | ||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
847
73.5%
|
218
71%
|
786
75.1%
|
283
80.2%
|
458
76%
|
2592
74.9%
|
| >=65 years |
306
26.5%
|
89
29%
|
260
24.9%
|
70
19.8%
|
145
24%
|
870
25.1%
|
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
57.8
(9.58)
|
58.1
(9.76)
|
57.2
(9.71)
|
56.4
(9.38)
|
57.4
(9.06)
|
57.4
(9.53)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
272
23.6%
|
78
25.4%
|
228
21.8%
|
67
19%
|
143
23.7%
|
788
22.8%
|
| Male |
881
76.4%
|
229
74.6%
|
818
78.2%
|
286
81%
|
460
76.3%
|
2674
77.2%
|
| Region of Enrollment (participants) [Number] | ||||||
| Australia |
75
6.5%
|
14
4.6%
|
73
7%
|
15
4.2%
|
29
4.8%
|
206
6%
|
| Belgium |
19
1.6%
|
3
1%
|
34
3.3%
|
9
2.5%
|
12
2%
|
77
2.2%
|
| Brazil |
11
1%
|
0
0%
|
26
2.5%
|
0
0%
|
0
0%
|
37
1.1%
|
| Bulgaria |
78
6.8%
|
47
15.3%
|
85
8.1%
|
7
2%
|
41
6.8%
|
258
7.5%
|
| Canada |
34
2.9%
|
2
0.7%
|
28
2.7%
|
7
2%
|
17
2.8%
|
88
2.5%
|
| China |
2
0.2%
|
0
0%
|
2
0.2%
|
0
0%
|
0
0%
|
4
0.1%
|
| Czech Republic |
48
4.2%
|
0
0%
|
58
5.5%
|
33
9.3%
|
41
6.8%
|
180
5.2%
|
| Denmark |
18
1.6%
|
16
5.2%
|
14
1.3%
|
7
2%
|
9
1.5%
|
64
1.8%
|
| Finland |
3
0.3%
|
0
0%
|
7
0.7%
|
0
0%
|
6
1%
|
16
0.5%
|
| France |
16
1.4%
|
1
0.3%
|
21
2%
|
5
1.4%
|
6
1%
|
49
1.4%
|
| Germany |
31
2.7%
|
3
1%
|
35
3.3%
|
11
3.1%
|
12
2%
|
92
2.7%
|
| Hungary |
11
1%
|
0
0%
|
14
1.3%
|
7
2%
|
4
0.7%
|
36
1%
|
| Israel |
43
3.7%
|
0
0%
|
26
2.5%
|
16
4.5%
|
11
1.8%
|
96
2.8%
|
| Italy |
43
3.7%
|
3
1%
|
56
5.4%
|
17
4.8%
|
17
2.8%
|
136
3.9%
|
| Korea (South) |
17
1.5%
|
0
0%
|
9
0.9%
|
10
2.8%
|
11
1.8%
|
47
1.4%
|
| Netherlands |
28
2.4%
|
0
0%
|
39
3.7%
|
9
2.5%
|
11
1.8%
|
87
2.5%
|
| New Zealand |
57
4.9%
|
22
7.2%
|
37
3.5%
|
8
2.3%
|
24
4%
|
148
4.3%
|
| Norway |
8
0.7%
|
3
1%
|
5
0.5%
|
0
0%
|
5
0.8%
|
21
0.6%
|
| Poland |
174
15.1%
|
4
1.3%
|
109
10.4%
|
86
24.4%
|
124
20.6%
|
497
14.4%
|
| Russia |
136
11.8%
|
90
29.3%
|
105
10%
|
17
4.8%
|
82
13.6%
|
430
12.4%
|
| Slovakia |
49
4.2%
|
1
0.3%
|
32
3.1%
|
13
3.7%
|
21
3.5%
|
116
3.4%
|
| South Africa |
6
0.5%
|
0
0%
|
7
0.7%
|
0
0%
|
4
0.7%
|
17
0.5%
|
| Spain |
35
3%
|
5
1.6%
|
36
3.4%
|
12
3.4%
|
15
2.5%
|
103
3%
|
| Sweden |
13
1.1%
|
2
0.7%
|
17
1.6%
|
6
1.7%
|
9
1.5%
|
47
1.4%
|
| Ukraine |
57
4.9%
|
21
6.8%
|
37
3.5%
|
11
3.1%
|
33
5.5%
|
159
4.6%
|
| United Kingdom |
9
0.8%
|
1
0.3%
|
19
1.8%
|
15
4.2%
|
8
1.3%
|
52
1.5%
|
| United States |
132
11.4%
|
69
22.5%
|
115
11%
|
32
9.1%
|
51
8.5%
|
399
11.5%
|
Outcome Measures
| Title | Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (Primary Safety) |
|---|---|
| Description | The number of patients with a first occurrence of a TIMI clinically significant bleeding event that occurred from the time of randomization to the time of the last patient contact. TIMI clinically significant bleeding events included TIMI minor bleeding events, TIMI major bleeding events, or any bleeding that required medical attention. |
| Time Frame | Day 1 to Day 210 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety population consisted of all randomized patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. |
| Arm/Group Title | Placebo | Riva 5 mg Total Daily Dose (TDD) | Riva 10 mg TDD | Riva 15 mg TDD | Riva 20 mg TDD |
|---|---|---|---|---|---|
| Arm/Group Description | One Placebo tablet twice daily for 6 months. | Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months. | Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months. | Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months. | Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months. |
| Measure Participants | 1153 | 307 | 1046 | 353 | 603 |
| Number [Patients] |
36
|
17
|
109
|
43
|
89
|
| Title | The Composite Endpoint of All Cause Death, Myocardial Infarction (MI) (Including Repeat MI), Stroke (Ischemic, Hemorrhagic or Unknown), or Severe Recurrent Ischemia Requiring Revascularization (Primary Efficacy) |
|---|---|
| Description | The number of patients who died due to any cause or had a first occurrence of MI (including repeat MI) or stroke (ischemic, hemorrhagic or unknown) or severe recurrent ischemia requiring revascularization from the time of randomization to the last date of patient contact. |
| Time Frame | Day 1 to Day 210 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The intent-to-treat (ITT) population consisted of all patients who were randomized to treatment, regardless of study drug intake. |
| Arm/Group Title | Placebo | Riva 5 mg Total Daily Dose (TDD) | Riva 10 mg TDD | Riva 15 mg TDD | Riva 20 mg TDD |
|---|---|---|---|---|---|
| Arm/Group Description | One Placebo tablet twice daily for 6 months. | Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months. | Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months. | Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months. | Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months. |
| Measure Participants | 1160 | 308 | 1056 | 356 | 611 |
| Number [Patients] |
83
|
23
|
55
|
27
|
36
|
| Title | The Composite Endpoint of Death (All Cause), Myocardial Infarction (MI) (or Repeat MI), or Stroke |
|---|---|
| Description | The number of patients who died due to any cause or had a first occurrence of MI (or repeat MI) or stroke from the time of randomization to the last date of patient contact. |
| Time Frame | Day 1 to Day 210 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT population consisted of all patients who were randomized to treatment, regardliess of study drug intake. |
| Arm/Group Title | Placebo | Riva 5 mg Total Daily Dose (TDD) | Riva 10 mg TDD | Riva 15 mg TDD | Riva 20 mg TDD |
|---|---|---|---|---|---|
| Arm/Group Description | One Placebo tablet twice daily for 6 months. | Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months. | Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months. | Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months. | Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months. |
| Measure Participants | 1160 | 308 | 1056 | 356 | 611 |
| Number [Patients] |
66
|
18
|
40
|
21
|
22
|
| Title | The Composite Endpoint of Cardiovascular Death, Myocardial Infarction (MI), or Stroke |
|---|---|
| Description | The number of patients with the composite endpoint of cardiovascular death or MI or stroke that occurred from the time of randomization to the last date of patient contact. |
| Time Frame | Day 1 to Day 210 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT population consisted of all patients who were randomized to treatment regardless of study drug intake. |
| Arm/Group Title | Placebo | Riva 5 mg Total Daily Dose (TDD) | Riva 10 mg TDD | Riva 15 mg TDD | Riva 20 mg TDD |
|---|---|---|---|---|---|
| Arm/Group Description | One Placebo tablet twice daily for 6 months. | Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months. | Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months. | Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months. | Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months. |
| Measure Participants | 1160 | 308 | 1056 | 356 | 611 |
| Number [Patients] |
63
|
18
|
40
|
21
|
21
|
| Title | The Number of Deaths (All Cause) |
|---|---|
| Description | The number of patients who died due to any cause from the time of randomization to the last date of patient contact. |
| Time Frame | Day 1 to Day 210 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT population consisted of all patients who were randomized to treatment, regardless of study drug intake. |
| Arm/Group Title | Placebo | Riva 5 mg Total Daily Dose (TDD) | Riva 10 mg TDD | Riva 15 mg TDD | Riva 20 mg TDD |
|---|---|---|---|---|---|
| Arm/Group Description | One Placebo tablet twice daily for 6 months. | Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months. | Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months. | Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months. | Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months. |
| Measure Participants | 1160 | 308 | 1056 | 356 | 611 |
| Number [Patients] |
18
|
11
|
9
|
4
|
9
|
| Title | The Composite Endpoint of Death (All Cause), MI (or reMI), Stroke, Severe Recurrent Ischemia Requiring Revascularization, or Thrombolysis in Myocardial Infarction (TIMI) (Major or Minor Bleeding) to Assess the Net Clinical Benefit |
|---|---|
| Description | The number of patients who died due to any cause or had a first occurrence of MI (or repeat MI), or stroke, or severe recurrent ischemia requiring revascularization, or TIMI (major or minor bleeding) from the time of randomization to the last date of patient contact to assess the net clinical benefit of rivaroxaban. |
| Time Frame | Day 1 to Day 210 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT population consisted of all patients who were randomized to treatment, regardless of study drug intake. |
| Arm/Group Title | Placebo | Riva 5 mg Total Daily Dose (TDD) | Riva 10 mg TDD | Riva 15 mg TDD | Riva 20 mg TDD |
|---|---|---|---|---|---|
| Arm/Group Description | One Placebo tablet twice daily for 6 months. | Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months. | Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months. | Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months. | Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months. |
| Measure Participants | 1160 | 308 | 1056 | 356 | 611 |
| Number [Patients] |
88
|
24
|
71
|
35
|
48
|
Adverse Events
| Time Frame | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events | |||||||||
| Arm/Group Title | Placebo | Riva 5 mg Total Daily Dose (TDD) | Riva 10 mg TDD | Riva 15 mg TDD | Riva 20 mg TDD | |||||
| Arm/Group Description | One placebo tablet twice daily for 6 months. | Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months. | Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months. | Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months. | Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months. | |||||
All Cause Mortality |
||||||||||
| Placebo | Riva 5 mg Total Daily Dose (TDD) | Riva 10 mg TDD | Riva 15 mg TDD | Riva 20 mg TDD | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| Placebo | Riva 5 mg Total Daily Dose (TDD) | Riva 10 mg TDD | Riva 15 mg TDD | Riva 20 mg TDD | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 247/1153 (21.4%) | 74/307 (24.1%) | 208/1046 (19.9%) | 72/353 (20.4%) | 128/603 (21.2%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 1/1153 (0.1%) | 0/307 (0%) | 3/1046 (0.3%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Haemorrhagic Anaemia | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Iron Deficiency Anaemia | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 1/603 (0.2%) | |||||
| Normochromic Normocytic Anaemia | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Thrombocythaemia | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Thrombocytopenia | 0/1153 (0%) | 1/307 (0.3%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Cardiac disorders | ||||||||||
| Acute Coronary Syndrome | 3/1153 (0.3%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 2/603 (0.3%) | |||||
| Acute Myocardial Infarction | 28/1153 (2.4%) | 6/307 (2%) | 13/1046 (1.2%) | 8/353 (2.3%) | 5/603 (0.8%) | |||||
| Angina Pectoris | 22/1153 (1.9%) | 4/307 (1.3%) | 16/1046 (1.5%) | 4/353 (1.1%) | 10/603 (1.7%) | |||||
| Angina Unstable | 42/1153 (3.6%) | 12/307 (3.9%) | 23/1046 (2.2%) | 11/353 (3.1%) | 21/603 (3.5%) | |||||
| Arteriosclerosis Coronary Artery | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Arteriospasm Coronary | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Atrial Fibrillation | 7/1153 (0.6%) | 5/307 (1.6%) | 6/1046 (0.6%) | 2/353 (0.6%) | 1/603 (0.2%) | |||||
| Atrial Flutter | 1/1153 (0.1%) | 0/307 (0%) | 3/1046 (0.3%) | 0/353 (0%) | 0/603 (0%) | |||||
| Atrioventricular Block Second Degree | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Bradycardia | 0/1153 (0%) | 1/307 (0.3%) | 2/1046 (0.2%) | 0/353 (0%) | 0/603 (0%) | |||||
| Cardiac Arrest | 2/1153 (0.2%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 3/603 (0.5%) | |||||
| Cardiac Failure | 6/1153 (0.5%) | 1/307 (0.3%) | 6/1046 (0.6%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Cardiac Failure Acute | 1/1153 (0.1%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Cardiac Failure Congestive | 0/1153 (0%) | 3/307 (1%) | 1/1046 (0.1%) | 3/353 (0.8%) | 1/603 (0.2%) | |||||
| Cardio-Respiratory Arrest | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Cardiogenic Shock | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Cardiomyopathy | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Coronary Artery Disease | 5/1153 (0.4%) | 0/307 (0%) | 3/1046 (0.3%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Coronary Artery Insufficiency | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Coronary Artery Occlusion | 1/1153 (0.1%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Coronary Artery Stenosis | 1/1153 (0.1%) | 1/307 (0.3%) | 0/1046 (0%) | 2/353 (0.6%) | 0/603 (0%) | |||||
| Dressler's Syndrome | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Intracardiac Thrombus | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Left Ventricular Dysfunction | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Left Ventricular Failure | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Myocardial Infarction | 5/1153 (0.4%) | 3/307 (1%) | 6/1046 (0.6%) | 3/353 (0.8%) | 8/603 (1.3%) | |||||
| Myocardial Ischaemia | 6/1153 (0.5%) | 1/307 (0.3%) | 12/1046 (1.1%) | 1/353 (0.3%) | 2/603 (0.3%) | |||||
| Palpitations | 1/1153 (0.1%) | 0/307 (0%) | 3/1046 (0.3%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Parasystole | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Pericardial Effusion | 2/1153 (0.2%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 1/603 (0.2%) | |||||
| Pericarditis | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Postinfarction Angina | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Sick Sinus Syndrome | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Sinus Bradycardia | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Ventricular Arrhythmia | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Ventricular Dysfunction | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Ventricular Extrasystoles | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Ventricular Fibrillation | 1/1153 (0.1%) | 0/307 (0%) | 1/1046 (0.1%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Ventricular Tachycardia | 0/1153 (0%) | 1/307 (0.3%) | 2/1046 (0.2%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Congenital, familial and genetic disorders | ||||||||||
| Endocardial Fibroelastosis | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Ear and labyrinth disorders | ||||||||||
| Vertigo | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Endocrine disorders | ||||||||||
| Hyperthyroidism | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Thyroid Disorder | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Eye disorders | ||||||||||
| Conjunctival Haemorrhage | 1/1153 (0.1%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Eye Haemorrhage | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Retinal Artery Thrombosis | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Vitreous Haemorrhage | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Abdominal Pain | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Abdominal Pain Upper | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Anal Fissure | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Colitis Ischaemic | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Dry Mouth | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Duodenal Ulcer | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Gastric Ulcer Haemorrhage | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Gastritis | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Gastrointestinal Haemorrhage | 2/1153 (0.2%) | 1/307 (0.3%) | 10/1046 (1%) | 3/353 (0.8%) | 6/603 (1%) | |||||
| Gastrooesophageal Reflux Disease | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Gingival Bleeding | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Haematemesis | 1/1153 (0.1%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Haemorrhoidal Haemorrhage | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Inguinal Hernia | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Intestinal Haemorrhage | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 1/603 (0.2%) | |||||
| Lower Gastrointestinal Haemorrhage | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Melaena | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 3/353 (0.8%) | 0/603 (0%) | |||||
| Nausea | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Oesophageal Haemorrhage | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Pancreatitis | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Pancreatitis Acute | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Peptic Ulcer | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Peptic Ulcer Haemorrhage | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Rectal Haemorrhage | 1/1153 (0.1%) | 1/307 (0.3%) | 0/1046 (0%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Retroperitoneal Haematoma | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Small Intestinal Haemorrhage | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Upper Gastrointestinal Haemorrhage | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Vomiting | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| General disorders | ||||||||||
| Asthenia | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 3/603 (0.5%) | |||||
| Catheter Site Haemorrhage | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Chest Discomfort | 1/1153 (0.1%) | 1/307 (0.3%) | 2/1046 (0.2%) | 0/353 (0%) | 2/603 (0.3%) | |||||
| Chest Pain | 24/1153 (2.1%) | 9/307 (2.9%) | 17/1046 (1.6%) | 2/353 (0.6%) | 9/603 (1.5%) | |||||
| Death | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Injection Site Phlebitis | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Non-Cardiac Chest Pain | 11/1153 (1%) | 4/307 (1.3%) | 13/1046 (1.2%) | 2/353 (0.6%) | 5/603 (0.8%) | |||||
| Puncture Site Haemorrhage | 0/1153 (0%) | 0/307 (0%) | 2/1046 (0.2%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Puncture Site Reaction | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Pyrexia | 1/1153 (0.1%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Sudden Cardiac Death | 3/1153 (0.3%) | 1/307 (0.3%) | 1/1046 (0.1%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Sudden Death | 0/1153 (0%) | 0/307 (0%) | 2/1046 (0.2%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Vessel Puncture Site Haemorrhage | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Hepatobiliary disorders | ||||||||||
| Cholecystitis | 2/1153 (0.2%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Cholecystitis Acute | 1/1153 (0.1%) | 1/307 (0.3%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Cholelithiasis | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 2/603 (0.3%) | |||||
| Immune system disorders | ||||||||||
| Anaphylactic Shock | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Infections and infestations | ||||||||||
| Abscess Limb | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Acarodermatitis | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Anal Abscess | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Bronchitis | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Bronchopneumonia | 1/1153 (0.1%) | 0/307 (0%) | 1/1046 (0.1%) | 1/353 (0.3%) | 2/603 (0.3%) | |||||
| Cellulitis | 2/1153 (0.2%) | 1/307 (0.3%) | 1/1046 (0.1%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Cellulitis Orbital | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Cellulitis Pharyngeal | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Device Related Infection | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Erysipelas | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Gangrene | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Gastroenteritis | 2/1153 (0.2%) | 0/307 (0%) | 2/1046 (0.2%) | 0/353 (0%) | 0/603 (0%) | |||||
| Gastrointestinal Infection | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Gingival Abscess | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Implant Site Infection | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Lobar Pneumonia | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Orchitis | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Pneumonia | 3/1153 (0.3%) | 1/307 (0.3%) | 1/1046 (0.1%) | 3/353 (0.8%) | 0/603 (0%) | |||||
| Post Procedural Infection | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Pyelonephritis | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Sepsis | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Staphylococcal Sepsis | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Urinary Tract Infection | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 1/603 (0.2%) | |||||
| Viral Infection | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Wound Infection | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Ankle Fracture | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Concussion | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Contusion | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Coronary Artery Restenosis | 2/1153 (0.2%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 2/603 (0.3%) | |||||
| Facial Bones Fracture | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Fall | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Head Injury | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Implantable Defibrillator Malfunction | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| In-Stent Coronary Artery Restenosis | 4/1153 (0.3%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Multiple Injuries | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Post Procedural Haematoma | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Radius Fracture | 1/1153 (0.1%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Rib Fracture | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Road Traffic Accident | 0/1153 (0%) | 1/307 (0.3%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Skull Fracture | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Subdural Haematoma | 0/1153 (0%) | 0/307 (0%) | 3/1046 (0.3%) | 0/353 (0%) | 0/603 (0%) | |||||
| Thrombosis in Device | 3/1153 (0.3%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Traumatic Haematoma | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Upper Limb Fracture | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Vascular Pseudoaneurysm | 0/1153 (0%) | 0/307 (0%) | 5/1046 (0.5%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Vascular Pseudoaneurysm Ruptured | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Investigations | ||||||||||
| Alanine Aminotransferase Increased | 2/1153 (0.2%) | 2/307 (0.7%) | 1/1046 (0.1%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Angiogram | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Arteriogram Coronary | 6/1153 (0.5%) | 0/307 (0%) | 3/1046 (0.3%) | 1/353 (0.3%) | 4/603 (0.7%) | |||||
| Aspartate Aminotransferase Increased | 0/1153 (0%) | 2/307 (0.7%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Blood Alkaline Phosphatase Increased | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Blood Bilirubin Increased | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Blood Pressure Increased | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| C-Reactive Protein Increased | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Chest X-Ray Abnormal | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Ejection Fraction Decreased | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Gamma-Glutamyltransferase Increased | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Haemoglobin Decreased | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 2/353 (0.6%) | 0/603 (0%) | |||||
| Hepatic Enzyme Increased | 1/1153 (0.1%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Liver Function Test Abnormal | 2/1153 (0.2%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Occult Blood | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Dehydration | 2/1153 (0.2%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Diabetes Mellitus | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 2/353 (0.6%) | 0/603 (0%) | |||||
| Hyperglycaemia | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Hypoglycaemia | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Arthralgia | 2/1153 (0.2%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Arthritis Reactive | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Back Disorder | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Back Pain | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Haemarthrosis | 0/1153 (0%) | 1/307 (0.3%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Musculoskeletal Chest Pain | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 3/603 (0.5%) | |||||
| Myalgia | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Osteoarthritis | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Pain in Extremity | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Spondyloarthropathy | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Breast Cancer in Situ | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Colon Cancer | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Colon Neoplasm | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Gastric Cancer | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Lung Neoplasm Malignant | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Meningioma | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Myelodysplastic Syndrome | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Ovarian Granulosa-Theca Cell Tumour | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Ovarian Neoplasm | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Rectal Cancer | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Nervous system disorders | ||||||||||
| Brain Oedema | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Carotid Artery Stenosis | 1/1153 (0.1%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Carpal Tunnel Syndrome | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Cerebral Infarction | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Cerebrovascular Accident | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Haemorrhage Intracranial | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Haemorrhagic Stroke | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Headache | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Ischaemic Cerebral Infarction | 0/1153 (0%) | 1/307 (0.3%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Ischaemic Stroke | 2/1153 (0.2%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Lethargy | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Motor Neurone Disease | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Presyncope | 2/1153 (0.2%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Progressive Supranuclear Palsy | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Somnolence | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Subarachnoid Haemorrhage | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Syncope | 2/1153 (0.2%) | 1/307 (0.3%) | 2/1046 (0.2%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Vascular Encephalopathy | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Vertebrobasilar Insufficiency | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Psychiatric disorders | ||||||||||
| Acute Psychosis | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Alcohol Withdrawal Syndrome | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Anxiety | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 2/353 (0.6%) | 1/603 (0.2%) | |||||
| Depression | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Drug Dependence | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Major Depression | 0/1153 (0%) | 0/307 (0%) | 2/1046 (0.2%) | 0/353 (0%) | 0/603 (0%) | |||||
| Mental Status Changes | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| Calculus Ureteric | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Calculus Urinary | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Cystitis Haemorrhagic | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Haematuria | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 3/603 (0.5%) | |||||
| Renal Colic | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Renal Failure Acute | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 2/603 (0.3%) | |||||
| Renal Haemorrhage | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Renal Impairment | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Reproductive system and breast disorders | ||||||||||
| Benign Prostatic Hyperplasia | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Menometrorrhagia | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Menorrhagia | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Metrorrhagia | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 2/353 (0.6%) | 0/603 (0%) | |||||
| Vaginal Haemorrhage | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Acute Pulmonary Oedema | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Acute Respiratory Failure | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Asthma | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Bronchopneumopathy | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Chronic Obstructive Pulmonary Disease | 3/1153 (0.3%) | 1/307 (0.3%) | 2/1046 (0.2%) | 0/353 (0%) | 0/603 (0%) | |||||
| Cough | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Dyspnoea | 2/1153 (0.2%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Dyspnoea Exertional | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Epistaxis | 2/1153 (0.2%) | 0/307 (0%) | 4/1046 (0.4%) | 3/353 (0.8%) | 4/603 (0.7%) | |||||
| Haemoptysis | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Haemothorax | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Hyperventilation | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Pleural Effusion | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Productive Cough | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Pulmonary Embolism | 4/1153 (0.3%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Pulmonary Oedema | 4/1153 (0.3%) | 3/307 (1%) | 2/1046 (0.2%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Rales | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Respiratory Distress | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Pruritus | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Rash Papular | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Skin Ulcer | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Surgical and medical procedures | ||||||||||
| Angioplasty | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Catheterisation Cardiac | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Coronary Arterial Stent Insertion | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Coronary Artery Bypass | 3/1153 (0.3%) | 2/307 (0.7%) | 2/1046 (0.2%) | 0/353 (0%) | 2/603 (0.3%) | |||||
| Coronary Revascularisation | 1/1153 (0.1%) | 0/307 (0%) | 4/1046 (0.4%) | 0/353 (0%) | 2/603 (0.3%) | |||||
| Elective Procedure | 2/1153 (0.2%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Elective Surgery | 1/1153 (0.1%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Implantable Defibrillator Insertion | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Percutaneous Coronary Intervention | 5/1153 (0.4%) | 1/307 (0.3%) | 6/1046 (0.6%) | 1/353 (0.3%) | 2/603 (0.3%) | |||||
| Surgery | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Vascular disorders | ||||||||||
| Aortic Aneurysm | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Aortic Arteriosclerosis | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Aortic Stenosis | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Arteriosclerosis | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Arteriovenous Fistula | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Femoral Arterial Stenosis | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Femoral Artery Occlusion | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Haematoma | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Hypertension | 2/1153 (0.2%) | 0/307 (0%) | 5/1046 (0.5%) | 0/353 (0%) | 2/603 (0.3%) | |||||
| Hypertensive Crisis | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Iliac Artery Occlusion | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Intermittent Claudication | 1/1153 (0.1%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Ischaemia | 0/1153 (0%) | 0/307 (0%) | 1/1046 (0.1%) | 0/353 (0%) | 0/603 (0%) | |||||
| Neovascularisation | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Orthostatic Hypotension | 1/1153 (0.1%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 1/603 (0.2%) | |||||
| Peripheral Arterial Occlusive Disease | 0/1153 (0%) | 0/307 (0%) | 0/1046 (0%) | 1/353 (0.3%) | 0/603 (0%) | |||||
| Phlebitis | 0/1153 (0%) | 1/307 (0.3%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
| Thrombosis | 1/1153 (0.1%) | 0/307 (0%) | 0/1046 (0%) | 0/353 (0%) | 0/603 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Placebo | Riva 5 mg Total Daily Dose (TDD) | Riva 10 mg TDD | Riva 15 mg TDD | Riva 20 mg TDD | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 223/1153 (19.3%) | 67/307 (21.8%) | 293/1046 (28%) | 108/353 (30.6%) | 148/603 (24.5%) | |||||
| Cardiac disorders | ||||||||||
| Angina Pectoris | 44/1153 (3.8%) | 16/307 (5.2%) | 43/1046 (4.1%) | 8/353 (2.3%) | 22/603 (3.6%) | |||||
| Gastrointestinal disorders | ||||||||||
| Gingival Bleeding | 13/1153 (1.1%) | 4/307 (1.3%) | 47/1046 (4.5%) | 32/353 (9.1%) | 33/603 (5.5%) | |||||
| General disorders | ||||||||||
| Chest Pain | 91/1153 (7.9%) | 26/307 (8.5%) | 99/1046 (9.5%) | 31/353 (8.8%) | 48/603 (8%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Contusion | 33/1153 (2.9%) | 8/307 (2.6%) | 40/1046 (3.8%) | 18/353 (5.1%) | 31/603 (5.1%) | |||||
| Nervous system disorders | ||||||||||
| Dizziness | 47/1153 (4.1%) | 16/307 (5.2%) | 32/1046 (3.1%) | 9/353 (2.5%) | 18/603 (3%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Epistaxis | 24/1153 (2.1%) | 11/307 (3.6%) | 89/1046 (8.5%) | 44/353 (12.5%) | 46/603 (7.6%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | VP FRANCHISE MED LDR |
|---|---|
| Organization | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. |
| Phone | 1 908 927 7767 |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00402597
Other Study ID Numbers:
- CR013417
- 39039039ACS2001
- NCT01151332
First Posted:
Nov 22, 2006
Last Update Posted:
Oct 4, 2012
Last Verified:
Sep 1, 2012