Trial Outcomes & Findings for An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome (NCT NCT00809965)
NCT ID: NCT00809965
Last Updated: 2014-09-17
Results Overview
The percentage of patients with the first occurrence of the composite of death, myocardial infarction, or stroke. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
15526 participants
Primary outcome timeframe
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
Results posted on
2014-09-17
Participant Flow
This study, an efficacy and safety study of rivaroxaban in patients with acute coronary syndrome, was conducted between 26 November 2008 and 19 September 2011. Patients were recruited from 766 study centers located in 44 countries worldwide.
A total of 15,526 patients were randomly allocated to the 3 treatment arms in the study. A total of 15,350 patients (5,115 patients in the rivaroxaban 2.5 mg bid group, 5,110 patients in the rivaroxaban 5 mg bid group and 5,125 patients in the placebo group) who received at least 1 dose of study drug were included in the safety analysis set.
Participant milestones
| Measure |
Placebo
One placebo tablet twice daily
|
Rivaroxaban 2.5 mg Bid
One rivaroxaban 2.5 mg tablet twice daily
|
Rivaroxaban 5 mg Bid
One rivaroxaban 5 mg tablet twice daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
5176
|
5174
|
5176
|
|
Overall Study
Treated/Safety Population
|
5125
|
5115
|
5110
|
|
Overall Study
Modified Intent-to-Treat Population
|
5113
|
5114
|
5115
|
|
Overall Study
COMPLETED
|
4393
|
4399
|
4332
|
|
Overall Study
NOT COMPLETED
|
783
|
775
|
844
|
Reasons for withdrawal
| Measure |
Placebo
One placebo tablet twice daily
|
Rivaroxaban 2.5 mg Bid
One rivaroxaban 2.5 mg tablet twice daily
|
Rivaroxaban 5 mg Bid
One rivaroxaban 5 mg tablet twice daily
|
|---|---|---|---|
|
Overall Study
Death
|
194
|
147
|
196
|
|
Overall Study
Lost to Follow-up
|
17
|
10
|
18
|
|
Overall Study
Withdrawal by Subject
|
405
|
448
|
441
|
|
Overall Study
Other Reason
|
167
|
170
|
189
|
Baseline Characteristics
An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome
Baseline characteristics by cohort
| Measure |
Placebo
n=5125 Participants
One placebo tablet twice daily
|
Rivaroxaban 2.5 mg Bid
n=5115 Participants
One rivaroxaban 2.5 mg tablet twice daily
|
Rivaroxaban 5 mg Bid
n=5110 Participants
One rivaroxaban 5 mg tablet twice daily
|
Total
n=15350 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3320 Participants
n=5 Participants
|
3239 Participants
n=7 Participants
|
3210 Participants
n=5 Participants
|
9769 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1805 Participants
n=5 Participants
|
1876 Participants
n=7 Participants
|
1900 Participants
n=5 Participants
|
5581 Participants
n=4 Participants
|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 9.38 • n=5 Participants
|
61.8 years
STANDARD_DEVIATION 9.22 • n=7 Participants
|
61.9 years
STANDARD_DEVIATION 9.00 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 9.20 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1280 Participants
n=5 Participants
|
1283 Participants
n=7 Participants
|
1316 Participants
n=5 Participants
|
3879 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3845 Participants
n=5 Participants
|
3832 Participants
n=7 Participants
|
3794 Participants
n=5 Participants
|
11471 Participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
59 participants
n=5 Participants
|
57 participants
n=7 Participants
|
53 participants
n=5 Participants
|
169 participants
n=4 Participants
|
|
Region of Enrollment
Argentina
|
118 participants
n=5 Participants
|
126 participants
n=7 Participants
|
158 participants
n=5 Participants
|
402 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
172 participants
n=5 Participants
|
182 participants
n=7 Participants
|
150 participants
n=5 Participants
|
504 participants
n=4 Participants
|
|
Region of Enrollment
Brazil
|
184 participants
n=5 Participants
|
171 participants
n=7 Participants
|
168 participants
n=5 Participants
|
523 participants
n=4 Participants
|
|
Region of Enrollment
Bulgaria
|
258 participants
n=5 Participants
|
264 participants
n=7 Participants
|
268 participants
n=5 Participants
|
790 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
67 participants
n=5 Participants
|
58 participants
n=7 Participants
|
63 participants
n=5 Participants
|
188 participants
n=4 Participants
|
|
Region of Enrollment
Chile
|
67 participants
n=5 Participants
|
65 participants
n=7 Participants
|
78 participants
n=5 Participants
|
210 participants
n=4 Participants
|
|
Region of Enrollment
China
|
281 participants
n=5 Participants
|
299 participants
n=7 Participants
|
302 participants
n=5 Participants
|
882 participants
n=4 Participants
|
|
Region of Enrollment
Colombia
|
97 participants
n=5 Participants
|
84 participants
n=7 Participants
|
87 participants
n=5 Participants
|
268 participants
n=4 Participants
|
|
Region of Enrollment
Croatia
|
21 participants
n=5 Participants
|
19 participants
n=7 Participants
|
22 participants
n=5 Participants
|
62 participants
n=4 Participants
|
|
Region of Enrollment
Czech Republic
|
154 participants
n=5 Participants
|
158 participants
n=7 Participants
|
170 participants
n=5 Participants
|
482 participants
n=4 Participants
|
|
Region of Enrollment
Denmark
|
35 participants
n=5 Participants
|
21 participants
n=7 Participants
|
41 participants
n=5 Participants
|
97 participants
n=4 Participants
|
|
Region of Enrollment
Egypt
|
63 participants
n=5 Participants
|
47 participants
n=7 Participants
|
46 participants
n=5 Participants
|
156 participants
n=4 Participants
|
|
Region of Enrollment
France
|
68 participants
n=5 Participants
|
67 participants
n=7 Participants
|
72 participants
n=5 Participants
|
207 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
101 participants
n=5 Participants
|
96 participants
n=7 Participants
|
122 participants
n=5 Participants
|
319 participants
n=4 Participants
|
|
Region of Enrollment
Greece
|
19 participants
n=5 Participants
|
21 participants
n=7 Participants
|
27 participants
n=5 Participants
|
67 participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
147 participants
n=5 Participants
|
142 participants
n=7 Participants
|
122 participants
n=5 Participants
|
411 participants
n=4 Participants
|
|
Region of Enrollment
India
|
479 participants
n=5 Participants
|
507 participants
n=7 Participants
|
473 participants
n=5 Participants
|
1459 participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
114 participants
n=5 Participants
|
122 participants
n=7 Participants
|
101 participants
n=5 Participants
|
337 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
78 participants
n=5 Participants
|
77 participants
n=7 Participants
|
77 participants
n=5 Participants
|
232 participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
131 participants
n=5 Participants
|
135 participants
n=7 Participants
|
131 participants
n=5 Participants
|
397 participants
n=4 Participants
|
|
Region of Enrollment
Latvia
|
27 participants
n=5 Participants
|
33 participants
n=7 Participants
|
40 participants
n=5 Participants
|
100 participants
n=4 Participants
|
|
Region of Enrollment
Lithuania
|
59 participants
n=5 Participants
|
51 participants
n=7 Participants
|
66 participants
n=5 Participants
|
176 participants
n=4 Participants
|
|
Region of Enrollment
Malaysia
|
36 participants
n=5 Participants
|
33 participants
n=7 Participants
|
26 participants
n=5 Participants
|
95 participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
71 participants
n=5 Participants
|
96 participants
n=7 Participants
|
86 participants
n=5 Participants
|
253 participants
n=4 Participants
|
|
Region of Enrollment
Morocco
|
12 participants
n=5 Participants
|
22 participants
n=7 Participants
|
22 participants
n=5 Participants
|
56 participants
n=4 Participants
|
|
Region of Enrollment
Netherlands
|
131 participants
n=5 Participants
|
113 participants
n=7 Participants
|
124 participants
n=5 Participants
|
368 participants
n=4 Participants
|
|
Region of Enrollment
New Zealand
|
28 participants
n=5 Participants
|
31 participants
n=7 Participants
|
38 participants
n=5 Participants
|
97 participants
n=4 Participants
|
|
Region of Enrollment
Philippines
|
19 participants
n=5 Participants
|
11 participants
n=7 Participants
|
8 participants
n=5 Participants
|
38 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
332 participants
n=5 Participants
|
361 participants
n=7 Participants
|
356 participants
n=5 Participants
|
1049 participants
n=4 Participants
|
|
Region of Enrollment
Portugal
|
36 participants
n=5 Participants
|
36 participants
n=7 Participants
|
43 participants
n=5 Participants
|
115 participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
103 participants
n=5 Participants
|
94 participants
n=7 Participants
|
107 participants
n=5 Participants
|
304 participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
586 participants
n=5 Participants
|
596 participants
n=7 Participants
|
569 participants
n=5 Participants
|
1751 participants
n=4 Participants
|
|
Region of Enrollment
Serbia
|
43 participants
n=5 Participants
|
45 participants
n=7 Participants
|
29 participants
n=5 Participants
|
117 participants
n=4 Participants
|
|
Region of Enrollment
Slovakia
|
67 participants
n=5 Participants
|
58 participants
n=7 Participants
|
53 participants
n=5 Participants
|
178 participants
n=4 Participants
|
|
Region of Enrollment
South Korea
|
57 participants
n=5 Participants
|
40 participants
n=7 Participants
|
49 participants
n=5 Participants
|
146 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
71 participants
n=5 Participants
|
73 participants
n=7 Participants
|
76 participants
n=5 Participants
|
220 participants
n=4 Participants
|
|
Region of Enrollment
Sweden
|
58 participants
n=5 Participants
|
41 participants
n=7 Participants
|
44 participants
n=5 Participants
|
143 participants
n=4 Participants
|
|
Region of Enrollment
Thailand
|
52 participants
n=5 Participants
|
50 participants
n=7 Participants
|
38 participants
n=5 Participants
|
140 participants
n=4 Participants
|
|
Region of Enrollment
Tunisia
|
60 participants
n=5 Participants
|
62 participants
n=7 Participants
|
52 participants
n=5 Participants
|
174 participants
n=4 Participants
|
|
Region of Enrollment
Turkey
|
37 participants
n=5 Participants
|
39 participants
n=7 Participants
|
41 participants
n=5 Participants
|
117 participants
n=4 Participants
|
|
Region of Enrollment
Ukraine
|
205 participants
n=5 Participants
|
210 participants
n=7 Participants
|
213 participants
n=5 Participants
|
628 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
79 participants
n=5 Participants
|
91 participants
n=7 Participants
|
75 participants
n=5 Participants
|
245 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
243 participants
n=5 Participants
|
211 participants
n=7 Participants
|
224 participants
n=5 Participants
|
678 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)Population: The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.
The percentage of patients with the first occurrence of the composite of death, myocardial infarction, or stroke. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
Outcome measures
| Measure |
Placebo
n=5113 Participants
One placebo tablet twice daily
|
Rivaroxaban 2.5 mg Bid
n=5114 Participants
One rivaroxaban 2.5 mg tablet twice daily
|
Rivaroxaban 5 mg Bid
n=5115 Participants
One rivaroxaban 5 mg tablet twice daily
|
|---|---|---|---|
|
The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke
|
7.4 Percentage of patients
|
6.1 Percentage of patients
|
6.1 Percentage of patients
|
SECONDARY outcome
Timeframe: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)Population: The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.
The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
Outcome measures
| Measure |
Placebo
n=5113 Participants
One placebo tablet twice daily
|
Rivaroxaban 2.5 mg Bid
n=5114 Participants
One rivaroxaban 2.5 mg tablet twice daily
|
Rivaroxaban 5 mg Bid
n=5115 Participants
One rivaroxaban 5 mg tablet twice daily
|
|---|---|---|---|
|
The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke
|
7.5 Percentage of patients
|
6.3 Percentage of patients
|
6.3 Percentage of patients
|
SECONDARY outcome
Timeframe: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)Population: The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.
The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
Outcome measures
| Measure |
Placebo
n=5113 Participants
One placebo tablet twice daily
|
Rivaroxaban 2.5 mg Bid
n=5114 Participants
One rivaroxaban 2.5 mg tablet twice daily
|
Rivaroxaban 5 mg Bid
n=5115 Participants
One rivaroxaban 5 mg tablet twice daily
|
|---|---|---|---|
|
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Ischemic Stroke, or TIMI Major Bleeding Event Not Associated With Coronary Artery Bypass Graft Surgery
|
7.6 Percentage of patients
|
7.1 Percentage of patients
|
7.2 Percentage of patients
|
SECONDARY outcome
Timeframe: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)Population: The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.
The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
Outcome measures
| Measure |
Placebo
n=5113 Participants
One placebo tablet twice daily
|
Rivaroxaban 2.5 mg Bid
n=5114 Participants
One rivaroxaban 2.5 mg tablet twice daily
|
Rivaroxaban 5 mg Bid
n=5115 Participants
One rivaroxaban 5 mg tablet twice daily
|
|---|---|---|---|
|
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization
|
9.4 Percentage of patients
|
8.5 Percentage of patients
|
8.2 Percentage of patients
|
SECONDARY outcome
Timeframe: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)Population: The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.
The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
Outcome measures
| Measure |
Placebo
n=5113 Participants
One placebo tablet twice daily
|
Rivaroxaban 2.5 mg Bid
n=5114 Participants
One rivaroxaban 2.5 mg tablet twice daily
|
Rivaroxaban 5 mg Bid
n=5115 Participants
One rivaroxaban 5 mg tablet twice daily
|
|---|---|---|---|
|
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization
|
8.7 Percentage of patients
|
7.3 Percentage of patients
|
7.6 Percentage of patients
|
Adverse Events
Placebo
Serious events: 1018 serious events
Other events: 140 other events
Deaths: 0 deaths
Rivaroxaban 2.5 mg Bid
Serious events: 1033 serious events
Other events: 259 other events
Deaths: 0 deaths
Rivaroxaban 5 mg Bid
Serious events: 1083 serious events
Other events: 341 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=5125 participants at risk
One placebo tablet twice daily
|
Rivaroxaban 2.5 mg Bid
n=5115 participants at risk
One rivaroxaban 2.5 mg tablet twice daily
|
Rivaroxaban 5 mg Bid
n=5110 participants at risk
One rivaroxaban 5 mg tablet twice daily
|
|---|---|---|---|
|
Infections and infestations
Oesophageal Candidiasis
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Infections and infestations
Orchitis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Otitis Externa
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Otitis Media Chronic
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Infections and infestations
Parotitis
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Infections and infestations
Pericoronitis
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Infections and infestations
Pneumonia
|
0.64%
33/5125
|
0.72%
37/5115
|
0.65%
33/5110
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Pneumonia Viral
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Postoperative Wound Infection
|
0.04%
2/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.02%
1/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Infections and infestations
Pyelonephritis
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Pyelonephritis Acute
|
0.04%
2/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Infections and infestations
Pyelonephritis Chronic
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Respiratory Tract Infection
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Infections and infestations
Sepsis
|
0.10%
5/5125
|
0.02%
1/5115
|
0.06%
3/5110
|
|
Infections and infestations
Septic Shock
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Infections and infestations
Sinusitis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Skin Infection
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Staphylococcal Abscess
|
0.04%
2/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Staphylococcal Infection
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Subcutaneous Abscess
|
0.00%
0/5125
|
0.02%
1/5115
|
0.04%
2/5110
|
|
Infections and infestations
Tinea Pedis
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.04%
2/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Infections and infestations
Urinary Tract Infection
|
0.16%
8/5125
|
0.18%
9/5115
|
0.18%
9/5110
|
|
Infections and infestations
Urinary Tract Infection Bacterial
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Infections and infestations
Urosepsis
|
0.04%
2/5125
|
0.04%
2/5115
|
0.10%
5/5110
|
|
Infections and infestations
Vestibular Neuronitis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Viral Infection
|
0.04%
2/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Viral Myocarditis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Wound Infection
|
0.06%
3/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Acetabulum Fracture
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Airway Burns
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Anaphylactic Transfusion Reaction
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Anastomotic Haemorrhage
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Anastomotic Ulcer
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Animal Bite
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Brain Contusion
|
0.00%
0/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Injury, poisoning and procedural complications
Cardiac Procedure Complication
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Cerebral Haemorrhage Traumatic
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Chemical Poisoning
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Concussion
|
0.02%
1/5125
|
0.04%
2/5115
|
0.04%
2/5110
|
|
Injury, poisoning and procedural complications
Contrast Media Reaction
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Contusion
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Coronary Artery Restenosis
|
0.00%
0/5125
|
0.10%
5/5115
|
0.04%
2/5110
|
|
Injury, poisoning and procedural complications
Extradural Haematoma
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Fall
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.04%
2/5125
|
0.04%
2/5115
|
0.04%
2/5110
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.02%
1/5125
|
0.02%
1/5115
|
0.06%
3/5110
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Fractured Skull Depressed
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Multiple Injuries
|
0.02%
1/5125
|
0.04%
2/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Muscle Injury
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Muscle Rupture
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Operative Haemorrhage
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
0.00%
0/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.00%
0/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.10%
5/5125
|
0.06%
3/5115
|
0.10%
5/5110
|
|
Injury, poisoning and procedural complications
Post Procedural Myocardial Infarction
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Procedural Site Reaction
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Renal Haematoma
|
0.00%
0/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.02%
1/5125
|
0.06%
3/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.02%
1/5125
|
0.06%
3/5115
|
0.04%
2/5110
|
|
Injury, poisoning and procedural complications
Spinal Column Injury
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Splenic Rupture
|
0.04%
2/5125
|
0.02%
1/5115
|
0.04%
2/5110
|
|
Injury, poisoning and procedural complications
Stab Wound
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Sternal Injury
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Subcutaneous Haematoma
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.02%
1/5125
|
0.02%
1/5115
|
0.06%
3/5110
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Thoracic Vertebral Fracture
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.04%
2/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Toxicity to Various Agents
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Traumatic Haematoma
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Traumatic Haemorrhage
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Traumatic Intracranial Haemorrhage
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
0.06%
3/5125
|
0.16%
8/5115
|
0.10%
5/5110
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Wound Necrosis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Investigations
Alanine Aminotransferase Increased
|
0.41%
21/5125
|
0.47%
24/5115
|
0.41%
21/5110
|
|
Investigations
Angiogram
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Investigations
Arteriogram Coronary
|
0.10%
5/5125
|
0.08%
4/5115
|
0.12%
6/5110
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.02%
1/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/5125
|
0.04%
2/5115
|
0.04%
2/5110
|
|
Investigations
Blood Glucose Increased
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/5125
|
0.02%
1/5115
|
0.06%
3/5110
|
|
Investigations
Cardiac Stress Test
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Investigations
Cardiac Stress Test Abnormal
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Investigations
Colonoscopy
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Investigations
Ejection Fraction Decreased
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Investigations
Electrocardiogram Change
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Investigations
Electrocardiogram St-T Change
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Investigations
Endoscopy Upper Gastrointestinal Tract
|
0.00%
0/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Investigations
Haemoglobin Decreased
|
0.02%
1/5125
|
0.16%
8/5115
|
0.10%
5/5110
|
|
Investigations
Hepatic Enzyme Increased
|
0.08%
4/5125
|
0.14%
7/5115
|
0.14%
7/5110
|
|
Investigations
Liver Function Test Abnormal
|
0.10%
5/5125
|
0.12%
6/5115
|
0.12%
6/5110
|
|
Investigations
Occult Blood Positive
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Investigations
Oxygen Saturation Decreased
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Investigations
Renal Function Test Abnormal
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Investigations
Transaminases Increased
|
0.04%
2/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Investigations
Troponin I Increased
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Investigations
Ultrasound Scan
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Investigations
Weight Decreased
|
0.04%
2/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Metabolism and nutrition disorders
Dehydration
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.18%
9/5125
|
0.23%
12/5115
|
0.18%
9/5110
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.04%
2/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Metabolism and nutrition disorders
Diabetic Foot
|
0.02%
1/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/5125
|
0.04%
2/5115
|
0.02%
1/5110
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5125
|
0.08%
4/5115
|
0.02%
1/5110
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.04%
2/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.02%
1/5125
|
0.04%
2/5115
|
0.08%
4/5110
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.04%
2/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.02%
1/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.08%
4/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Musculoskeletal and connective tissue disorders
Bone Disorder
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Musculoskeletal and connective tissue disorders
Bunion
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis Pyrophosphate
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Musculoskeletal and connective tissue disorders
Compartment Syndrome
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.04%
2/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Disorder
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Displacement
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.08%
4/5125
|
0.04%
2/5115
|
0.02%
1/5110
|
|
Musculoskeletal and connective tissue disorders
Jaw Cyst
|
0.02%
1/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Musculoskeletal and connective tissue disorders
Muscle Haemorrhage
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/5125
|
0.04%
2/5115
|
0.04%
2/5110
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/5125
|
0.04%
2/5115
|
0.04%
2/5110
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.04%
2/5125
|
0.02%
1/5115
|
0.06%
3/5110
|
|
Musculoskeletal and connective tissue disorders
Osteochondritis
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.02%
1/5125
|
0.04%
2/5115
|
0.04%
2/5110
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.00%
0/5125
|
0.06%
3/5115
|
0.04%
2/5110
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.02%
1/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Musculoskeletal and connective tissue disorders
Soft Tissue Necrosis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.02%
1/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Musculoskeletal and connective tissue disorders
Spinal Disorder
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Leukaemia
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal Neoplasm
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal Cancer
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile Duct Cancer
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.04%
2/5125
|
0.06%
3/5115
|
0.04%
2/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Neoplasm
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carcinoma
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm Malignant
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.02%
1/5125
|
0.06%
3/5115
|
0.04%
2/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Female
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial Carcinoma
|
0.08%
4/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac Myxoma
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix Carcinoma Stage 0
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Lymphocytic Leukaemia
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Adenoma
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.02%
1/5125
|
0.04%
2/5115
|
0.04%
2/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Metastatic
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Stage Iv
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Neoplasm
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse Large B-Cell Lymphoma
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ear Neoplasm
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Cancer
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Cancer Metastatic
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Female Reproductive Neoplasm
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder Cancer
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.08%
4/5125
|
0.02%
1/5115
|
0.04%
2/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer Stage 0
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Neoplasm
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Carcinoma
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm Malignant
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's Disease
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal Cancer
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal Neoplasm
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer Metastatic
|
0.00%
0/5125
|
0.02%
1/5115
|
0.04%
2/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm
|
0.04%
2/5125
|
0.04%
2/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.06%
3/5125
|
0.02%
1/5115
|
0.06%
3/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma Malignant
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Bone
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Central Nervous System
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Lung
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Bronchial Carcinoma
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Gastric Cancer
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Neoplasm
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple Myeloma
|
0.00%
0/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Malignant
|
0.00%
0/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurilemmoma
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's Lymphoma
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Small Cell Lung Cancer
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Carcinoma
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal Cancer Stage Unspecified
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteoma
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer Metastatic
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.02%
1/5125
|
0.04%
2/5115
|
0.04%
2/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Neoplasm
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia Vera
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.06%
3/5125
|
0.08%
4/5115
|
0.10%
5/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic Adenoma
|
0.02%
1/5125
|
0.02%
1/5115
|
0.04%
2/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.02%
1/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer Recurrent
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Neoplasm
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid Cancer
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Neoplasm
|
0.04%
2/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary Gland Adenoma
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Signet-Ring Cell Carcinoma
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Cancer
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of the Cervix
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat Cancer
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.00%
0/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urinary Tract Neoplasm
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Cancer
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vaginal Cancer
|
0.00%
0/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Amnesia
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Ataxia
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Nervous system disorders
Basal Ganglia Haemorrhage
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Brain Injury
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Haematuria Traumatic
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.06%
3/5125
|
0.06%
3/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.02%
1/5125
|
0.06%
3/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.02%
1/5125
|
0.02%
1/5115
|
0.04%
2/5110
|
|
Injury, poisoning and procedural complications
In-Stent Arterial Restenosis
|
0.02%
1/5125
|
0.02%
1/5115
|
0.04%
2/5110
|
|
Injury, poisoning and procedural complications
In-Stent Coronary Artery Restenosis
|
0.08%
4/5125
|
0.06%
3/5115
|
0.14%
7/5110
|
|
Injury, poisoning and procedural complications
Incision Site Haematoma
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Incision Site Haemorrhage
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Injury
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Blood and lymphatic system disorders
Anaemia
|
0.06%
3/5125
|
0.12%
6/5115
|
0.22%
11/5110
|
|
Blood and lymphatic system disorders
Anaemia Megaloblastic
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Blood and lymphatic system disorders
Aplastic Anaemia
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Blood and lymphatic system disorders
Haemorrhagic Anaemia
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/5125
|
0.00%
0/5115
|
0.06%
3/5110
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Blood and lymphatic system disorders
Microcytic Anaemia
|
0.02%
1/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Blood and lymphatic system disorders
Spontaneous Haematoma
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.04%
2/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.18%
9/5125
|
0.14%
7/5115
|
0.14%
7/5110
|
|
Cardiac disorders
Acute Left Ventricular Failure
|
0.04%
2/5125
|
0.08%
4/5115
|
0.06%
3/5110
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.49%
25/5125
|
0.29%
15/5115
|
0.33%
17/5110
|
|
Cardiac disorders
Adams-Stokes Syndrome
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Angina Pectoris
|
2.3%
118/5125
|
1.8%
93/5115
|
2.1%
106/5110
|
|
Cardiac disorders
Angina Unstable
|
2.0%
100/5125
|
2.1%
105/5115
|
2.4%
123/5110
|
|
Cardiac disorders
Aortic Valve Disease
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Arrhythmia
|
0.08%
4/5125
|
0.02%
1/5115
|
0.08%
4/5110
|
|
Cardiac disorders
Arrhythmia Supraventricular
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Atrial Fibrillation
|
0.53%
27/5125
|
0.53%
27/5115
|
0.41%
21/5110
|
|
Cardiac disorders
Atrial Flutter
|
0.08%
4/5125
|
0.06%
3/5115
|
0.16%
8/5110
|
|
Cardiac disorders
Atrial Tachycardia
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Cardiac disorders
Atrioventricular Block
|
0.04%
2/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.04%
2/5125
|
0.10%
5/5115
|
0.08%
4/5110
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.02%
1/5125
|
0.06%
3/5115
|
0.02%
1/5110
|
|
Cardiac disorders
Bradycardia
|
0.02%
1/5125
|
0.02%
1/5115
|
0.06%
3/5110
|
|
Cardiac disorders
Bundle Branch Block Left
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Cardiac disorders
Bundle Branch Block Right
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Cardiac disorders
Cardiac Aneurysm
|
0.00%
0/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Cardiac disorders
Cardiac Arrest
|
0.18%
9/5125
|
0.10%
5/5115
|
0.14%
7/5110
|
|
Cardiac disorders
Cardiac Asthma
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Cardiac disorders
Cardiac Failure
|
0.80%
41/5125
|
1.1%
56/5115
|
0.53%
27/5110
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.25%
13/5125
|
0.27%
14/5115
|
0.20%
10/5110
|
|
Cardiac disorders
Cardiac Failure Chronic
|
0.08%
4/5125
|
0.12%
6/5115
|
0.14%
7/5110
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.41%
21/5125
|
0.29%
15/5115
|
0.39%
20/5110
|
|
Cardiac disorders
Cardiac Flutter
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Cardiac disorders
Cardiac Pseudoaneurysm
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Cardiac disorders
Cardiac Tamponade
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/5125
|
0.04%
2/5115
|
0.04%
2/5110
|
|
Cardiac disorders
Cardiogenic Shock
|
0.14%
7/5125
|
0.18%
9/5115
|
0.08%
4/5110
|
|
Cardiac disorders
Cardiovascular Insufficiency
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Cardiac disorders
Coronary Artery Aneurysm
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Coronary Artery Disease
|
0.31%
16/5125
|
0.51%
26/5115
|
0.25%
13/5110
|
|
Cardiac disorders
Coronary Artery Dissection
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Cardiac disorders
Coronary Artery Insufficiency
|
0.04%
2/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.06%
3/5125
|
0.06%
3/5115
|
0.14%
7/5110
|
|
Cardiac disorders
Dressler's Syndrome
|
0.02%
1/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Cardiac disorders
Intracardiac Thrombus
|
0.06%
3/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
0.04%
2/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
0.04%
2/5125
|
0.04%
2/5115
|
0.04%
2/5110
|
|
Cardiac disorders
Left Ventricular Failure
|
0.12%
6/5125
|
0.14%
7/5115
|
0.10%
5/5110
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.00%
0/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Myocardial Infarction
|
0.31%
16/5125
|
0.20%
10/5115
|
0.43%
22/5110
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.25%
13/5125
|
0.29%
15/5115
|
0.29%
15/5110
|
|
Cardiac disorders
Myocardial Rupture
|
0.06%
3/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Cardiac disorders
Nodal Arrhythmia
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Nodal Rhythm
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Palpitations
|
0.04%
2/5125
|
0.04%
2/5115
|
0.06%
3/5110
|
|
Cardiac disorders
Papillary Muscle Rupture
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Pericardial Effusion
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Cardiac disorders
Pericardial Haemorrhage
|
0.00%
0/5125
|
0.00%
0/5115
|
0.08%
4/5110
|
|
Cardiac disorders
Pericarditis
|
0.02%
1/5125
|
0.02%
1/5115
|
0.04%
2/5110
|
|
Cardiac disorders
Postinfarction Angina
|
0.04%
2/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Cardiac disorders
Prinzmetal Angina
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Right Ventricular Failure
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.04%
2/5125
|
0.06%
3/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Silent Myocardial Infarction
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Cardiac disorders
Sinoatrial Block
|
0.02%
1/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Cardiac disorders
Sinus Arrhythmia
|
0.04%
2/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Sinus Bradycardia
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Supraventricular Extrasystoles
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.04%
2/5125
|
0.06%
3/5115
|
0.12%
6/5110
|
|
Cardiac disorders
Tachyarrhythmia
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Tachycardia
|
0.06%
3/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Tachycardia Paroxysmal
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Torsade De Pointes
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.02%
1/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.16%
8/5125
|
0.12%
6/5115
|
0.16%
8/5110
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.20%
10/5125
|
0.20%
10/5115
|
0.08%
4/5110
|
|
Congenital, familial and genetic disorders
Atrial Septal Defect
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Congenital, familial and genetic disorders
Gastrointestinal Angiodysplasia
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Congenital, familial and genetic disorders
Hip Dysplasia
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Ear and labyrinth disorders
Acute Vestibular Syndrome
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Ear and labyrinth disorders
Deafness
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Ear and labyrinth disorders
Deafness Neurosensory
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Ear and labyrinth disorders
Ear Haemorrhage
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Ear and labyrinth disorders
Middle Ear Inflammation
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Ear and labyrinth disorders
Vertigo
|
0.06%
3/5125
|
0.06%
3/5115
|
0.06%
3/5110
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Endocrine disorders
Autoimmune Thyroiditis
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Eye disorders
Blindness
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Eye disorders
Cataract
|
0.10%
5/5125
|
0.06%
3/5115
|
0.02%
1/5110
|
|
Eye disorders
Conjunctival Haemorrhage
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Eye disorders
Eye Haemorrhage
|
0.06%
3/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Eye disorders
Glaucoma
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Eye disorders
Hyphaema
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Eye disorders
Vitreous Haemorrhage
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.10%
5/5125
|
0.10%
5/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.08%
4/5125
|
0.08%
4/5115
|
0.06%
3/5110
|
|
Gastrointestinal disorders
Anal Fissure
|
0.02%
1/5125
|
0.04%
2/5115
|
0.04%
2/5110
|
|
Gastrointestinal disorders
Anal Fistula
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Appendix Disorder
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Colonic Polyp
|
0.00%
0/5125
|
0.00%
0/5115
|
0.06%
3/5110
|
|
Gastrointestinal disorders
Constipation
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Diarrhoea
|
0.06%
3/5125
|
0.04%
2/5115
|
0.06%
3/5110
|
|
Gastrointestinal disorders
Diverticulitis Intestinal Haemorrhagic
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Diverticulum Intestinal Haemorrhagic
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.04%
2/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Duodenal Ulcer Haemorrhage
|
0.00%
0/5125
|
0.04%
2/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Duodenitis
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Dysphagia
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Enterocolitis Haemorrhagic
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Erosive Oesophagitis
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Food Poisoning
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Gastric Dysplasia
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
0.04%
2/5125
|
0.04%
2/5115
|
0.06%
3/5110
|
|
Gastrointestinal disorders
Gastric Polyps
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.08%
4/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.02%
1/5125
|
0.06%
3/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Gastritis
|
0.14%
7/5125
|
0.10%
5/5115
|
0.08%
4/5110
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.00%
0/5125
|
0.06%
3/5115
|
0.12%
6/5110
|
|
Gastrointestinal disorders
Gastritis Haemorrhagic
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.21%
11/5125
|
0.35%
18/5115
|
0.63%
32/5110
|
|
Gastrointestinal disorders
Gastrointestinal Ulcer Haemorrhage
|
0.04%
2/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.08%
4/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.02%
1/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Gastrointestinal disorders
Gingival Swelling
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Haematemesis
|
0.02%
1/5125
|
0.02%
1/5115
|
0.08%
4/5110
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Haemorrhagic Erosive Gastritis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.00%
0/5125
|
0.08%
4/5115
|
0.16%
8/5110
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.02%
1/5125
|
0.00%
0/5115
|
0.06%
3/5110
|
|
Gastrointestinal disorders
Ileus
|
0.02%
1/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Ileus Paralytic
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.04%
2/5125
|
0.04%
2/5115
|
0.10%
5/5110
|
|
Gastrointestinal disorders
Inguinal Hernia, Obstructive
|
0.04%
2/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Intestinal Haemorrhage
|
0.00%
0/5125
|
0.04%
2/5115
|
0.06%
3/5110
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.02%
1/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Gastrointestinal disorders
Intestinal Polyp Haemorrhage
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.00%
0/5125
|
0.04%
2/5115
|
0.06%
3/5110
|
|
Gastrointestinal disorders
Mallory-Weiss Syndrome
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Melaena
|
0.08%
4/5125
|
0.14%
7/5115
|
0.16%
8/5110
|
|
Gastrointestinal disorders
Mesenteric Panniculitis
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Oesophageal Spasm
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Oesophagitis
|
0.04%
2/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Pancreatic Necrosis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Pancreatitis
|
0.12%
6/5125
|
0.08%
4/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.06%
3/5125
|
0.12%
6/5115
|
0.04%
2/5110
|
|
Gastrointestinal disorders
Pancreatitis Chronic
|
0.04%
2/5125
|
0.04%
2/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Peptic Ulcer
|
0.00%
0/5125
|
0.04%
2/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Periproctitis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Peritoneal Haemorrhage
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Proctocolitis
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Pseudodiverticular Disease
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Radicular Cyst
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.08%
4/5125
|
0.18%
9/5115
|
0.16%
8/5110
|
|
Gastrointestinal disorders
Rectal Polyp
|
0.00%
0/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Reflux Oesophagitis
|
0.04%
2/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Retroperitoneal Haematoma
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Salivary Gland Cyst
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Sigmoiditis
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Gastrointestinal disorders
Small Intestinal Haemorrhage
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.02%
1/5125
|
0.04%
2/5115
|
0.02%
1/5110
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.10%
5/5125
|
0.18%
9/5115
|
0.27%
14/5110
|
|
Gastrointestinal disorders
Vomiting
|
0.04%
2/5125
|
0.06%
3/5115
|
0.00%
0/5110
|
|
General disorders
Accidental Death
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
General disorders
Asthenia
|
0.04%
2/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
General disorders
Cardiac Death
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
General disorders
Chest Discomfort
|
0.02%
1/5125
|
0.04%
2/5115
|
0.06%
3/5110
|
|
General disorders
Chest Pain
|
0.64%
33/5125
|
0.92%
47/5115
|
0.65%
33/5110
|
|
General disorders
Condition Aggravated
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
General disorders
Cyst Rupture
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
General disorders
Death
|
0.21%
11/5125
|
0.10%
5/5115
|
0.18%
9/5110
|
|
General disorders
Device Lead Damage
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
General disorders
Device Occlusion
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
General disorders
Fatigue
|
0.02%
1/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
General disorders
Gait Disturbance
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
General disorders
Generalised Oedema
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
General disorders
Hernia
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
General disorders
Hernia Obstructive
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
General disorders
Impaired Healing
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
General disorders
Influenza Like Illness
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
General disorders
Malaise
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
General disorders
Medical Device Complication
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
General disorders
Multi-Organ Failure
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
General disorders
Non-Cardiac Chest Pain
|
0.76%
39/5125
|
0.70%
36/5115
|
0.94%
48/5110
|
|
General disorders
Oedema Peripheral
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
General disorders
Puncture Site Haemorrhage
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
General disorders
Pyrexia
|
0.06%
3/5125
|
0.10%
5/5115
|
0.14%
7/5110
|
|
General disorders
Sudden Cardiac Death
|
0.25%
13/5125
|
0.18%
9/5115
|
0.20%
10/5110
|
|
General disorders
Sudden Death
|
0.70%
36/5125
|
0.45%
23/5115
|
0.57%
29/5110
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
General disorders
Thrombosis in Device
|
0.04%
2/5125
|
0.02%
1/5115
|
0.04%
2/5110
|
|
General disorders
Vessel Puncture Site Haematoma
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.02%
1/5125
|
0.02%
1/5115
|
0.04%
2/5110
|
|
Hepatobiliary disorders
Biliary Colic
|
0.00%
0/5125
|
0.04%
2/5115
|
0.02%
1/5110
|
|
Hepatobiliary disorders
Cholecystitis
|
0.14%
7/5125
|
0.16%
8/5115
|
0.18%
9/5110
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.06%
3/5125
|
0.08%
4/5115
|
0.04%
2/5110
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.02%
1/5125
|
0.00%
0/5115
|
0.06%
3/5110
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.08%
4/5125
|
0.06%
3/5115
|
0.08%
4/5110
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.04%
2/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Hepatobiliary disorders
Hepatitis
|
0.02%
1/5125
|
0.04%
2/5115
|
0.04%
2/5110
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Hepatobiliary disorders
Jaundice
|
0.02%
1/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Hepatobiliary disorders
Jaundice Cholestatic
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Immune system disorders
Anaphylactic Reaction
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Immune system disorders
Drug Hypersensitivity
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Immune system disorders
Immune Reconstitution Syndrome
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Anal Abscess
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Appendicitis
|
0.06%
3/5125
|
0.02%
1/5115
|
0.06%
3/5110
|
|
Infections and infestations
Appendicitis Perforated
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Infections and infestations
Bacteraemia
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Bacterial Prostatitis
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Infections and infestations
Borrelia Infection
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Bronchitis
|
0.06%
3/5125
|
0.10%
5/5115
|
0.10%
5/5110
|
|
Infections and infestations
Bronchopneumonia
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Infections and infestations
Cellulitis
|
0.10%
5/5125
|
0.14%
7/5115
|
0.02%
1/5110
|
|
Infections and infestations
Clostridial Infection
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Infections and infestations
Cystitis
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Infections and infestations
Dengue Fever
|
0.00%
0/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Infections and infestations
Device Related Infection
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Infections and infestations
Diabetic Gangrene
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Infections and infestations
Diverticulitis
|
0.06%
3/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Infections and infestations
Empyema
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Infections and infestations
Endocarditis
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Infections and infestations
Enteritis Infectious
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Erysipelas
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Eyelid Infection
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Gangrene
|
0.02%
1/5125
|
0.04%
2/5115
|
0.02%
1/5110
|
|
Infections and infestations
Gastroenteritis
|
0.08%
4/5125
|
0.12%
6/5115
|
0.08%
4/5110
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Gastrointestinal Infection
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Infections and infestations
Graft Infection
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Infections and infestations
Groin Abscess
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Infections and infestations
Groin Infection
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
H1n1 Influenza
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Hepatitis B
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Infections and infestations
Hepatitis C
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Infections and infestations
Hepatitis E
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Hepatitis Viral
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Infections and infestations
Herpes Zoster
|
0.04%
2/5125
|
0.02%
1/5115
|
0.04%
2/5110
|
|
Infections and infestations
Herpes Zoster Infection Neurological
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Infections and infestations
Incision Site Infection
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Infection
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Infections and infestations
Infective Exacerbation of Chronic Obstructive Airways Disease
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Infections and infestations
Infective Spondylitis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Influenza
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Localised Infection
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.04%
2/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Infections and infestations
Lung Abscess
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Infections and infestations
Lung Infection
|
0.04%
2/5125
|
0.06%
3/5115
|
0.02%
1/5110
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Meningitis
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Infections and infestations
Meningitis Pneumococcal
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Infections and infestations
Neutropenic Infection
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Brain Oedema
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Brain Stem Infarction
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Carotid Arteriosclerosis
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Carotid Artery Disease
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Carotid Artery Occlusion
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Cerebellar Haemorrhage
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Cerebral Artery Embolism
|
0.00%
0/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Nervous system disorders
Cerebral Artery Stenosis
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.06%
3/5125
|
0.02%
1/5115
|
0.08%
4/5110
|
|
Nervous system disorders
Cerebral Infarction
|
0.04%
2/5125
|
0.02%
1/5115
|
0.10%
5/5110
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.04%
2/5125
|
0.10%
5/5115
|
0.10%
5/5110
|
|
Nervous system disorders
Cerebrovascular Disorder
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Cerebrovascular Insufficiency
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Coma
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Nervous system disorders
Convulsion
|
0.00%
0/5125
|
0.02%
1/5115
|
0.04%
2/5110
|
|
Nervous system disorders
Diabetic Neuropathy
|
0.04%
2/5125
|
0.06%
3/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Dizziness
|
0.12%
6/5125
|
0.10%
5/5115
|
0.08%
4/5110
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Nervous system disorders
Encephalopathy
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Epilepsy
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Grand Mal Convulsion
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.00%
0/5125
|
0.12%
6/5115
|
0.18%
9/5110
|
|
Nervous system disorders
Haemorrhagic Cerebral Infarction
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.06%
3/5125
|
0.02%
1/5115
|
0.06%
3/5110
|
|
Nervous system disorders
Headache
|
0.02%
1/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Nervous system disorders
Hypertensive Encephalopathy
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Intercostal Neuralgia
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Intracranial Haematoma
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Intraventricular Haemorrhage
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Nervous system disorders
Ischaemic Cerebral Infarction
|
0.10%
5/5125
|
0.04%
2/5115
|
0.08%
4/5110
|
|
Nervous system disorders
Ischaemic Stroke
|
0.35%
18/5125
|
0.23%
12/5115
|
0.31%
16/5110
|
|
Nervous system disorders
Lacunar Infarction
|
0.12%
6/5125
|
0.08%
4/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Loss of Consciousness
|
0.04%
2/5125
|
0.04%
2/5115
|
0.04%
2/5110
|
|
Nervous system disorders
Lumbar Radiculopathy
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Nervous system disorders
Migraine
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Paraesthesia
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Peripheral Nerve Palsy
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Nervous system disorders
Polyneuropathy
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Presyncope
|
0.04%
2/5125
|
0.04%
2/5115
|
0.06%
3/5110
|
|
Nervous system disorders
Radiculitis Cervical
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Nervous system disorders
Radiculopathy
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Speech Disorder
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Nervous system disorders
Spinal Claudication
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.02%
1/5125
|
0.02%
1/5115
|
0.06%
3/5110
|
|
Nervous system disorders
Syncope
|
0.21%
11/5125
|
0.12%
6/5115
|
0.31%
16/5110
|
|
Nervous system disorders
Thalamus Haemorrhage
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Thrombotic Cerebral Infarction
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.20%
10/5125
|
0.08%
4/5115
|
0.20%
10/5110
|
|
Nervous system disorders
Vertebrobasilar Insufficiency
|
0.02%
1/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Nervous system disorders
Viith Nerve Paralysis
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Psychiatric disorders
Acute Psychosis
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Psychiatric disorders
Anxiety
|
0.06%
3/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Psychiatric disorders
Anxiety Disorder
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Psychiatric disorders
Burnout Syndrome
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Psychiatric disorders
Completed Suicide
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Psychiatric disorders
Delirium
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Psychiatric disorders
Depression
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Psychiatric disorders
Mania
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Psychiatric disorders
Mental Status Changes
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Psychiatric disorders
Neurosis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Renal and urinary disorders
Bladder Disorder
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Renal and urinary disorders
Bladder Obstruction
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Renal and urinary disorders
Calculus Ureteric
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Renal and urinary disorders
Calculus Urinary
|
0.06%
3/5125
|
0.04%
2/5115
|
0.02%
1/5110
|
|
Renal and urinary disorders
Diabetic Nephropathy
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Renal and urinary disorders
Haematuria
|
0.04%
2/5125
|
0.14%
7/5115
|
0.41%
21/5110
|
|
Renal and urinary disorders
Haemorrhage Urinary Tract
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Renal and urinary disorders
Hydronephrosis
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Renal and urinary disorders
Hypertensive Nephropathy
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.06%
3/5125
|
0.06%
3/5115
|
0.06%
3/5110
|
|
Renal and urinary disorders
Neurogenic Bladder
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.02%
1/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Renal and urinary disorders
Renal Colic
|
0.02%
1/5125
|
0.02%
1/5115
|
0.06%
3/5110
|
|
Renal and urinary disorders
Renal Failure
|
0.08%
4/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.06%
3/5125
|
0.06%
3/5115
|
0.04%
2/5110
|
|
Renal and urinary disorders
Renal Failure Chronic
|
0.00%
0/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Renal and urinary disorders
Renal Haemorrhage
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Renal and urinary disorders
Renal Impairment
|
0.04%
2/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Renal and urinary disorders
Renal Mass
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Renal and urinary disorders
Urethral Haemorrhage
|
0.00%
0/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Renal and urinary disorders
Urethral Meatus Stenosis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Renal and urinary disorders
Urinary Bladder Polyp
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Renal and urinary disorders
Urinary Retention
|
0.06%
3/5125
|
0.02%
1/5115
|
0.08%
4/5110
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.04%
2/5125
|
0.02%
1/5115
|
0.08%
4/5110
|
|
Reproductive system and breast disorders
Calculus Prostatic
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Reproductive system and breast disorders
Leukoplakia of Penis
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Reproductive system and breast disorders
Postmenopausal Haemorrhage
|
0.04%
2/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Reproductive system and breast disorders
Prostatitis
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Reproductive system and breast disorders
Uterine Haemorrhage
|
0.00%
0/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/5125
|
0.08%
4/5115
|
0.00%
0/5110
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.16%
8/5125
|
0.20%
10/5115
|
0.12%
6/5110
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.04%
2/5125
|
0.04%
2/5115
|
0.02%
1/5110
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Respiratory, thoracic and mediastinal disorders
Brain Hypoxia
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Fistula
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
|
0.04%
2/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.12%
6/5125
|
0.18%
9/5115
|
0.08%
4/5110
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.02%
1/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.37%
19/5125
|
0.23%
12/5115
|
0.22%
11/5110
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/5125
|
0.04%
2/5115
|
0.02%
1/5110
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at Rest
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.02%
1/5125
|
0.20%
10/5115
|
0.20%
10/5110
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.02%
1/5125
|
0.02%
1/5115
|
0.06%
3/5110
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Respiratory, thoracic and mediastinal disorders
Lung Consolidation
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Respiratory, thoracic and mediastinal disorders
Organising Pneumonia
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/5125
|
0.04%
2/5115
|
0.02%
1/5110
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.04%
2/5125
|
0.00%
0/5115
|
0.06%
3/5110
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.12%
6/5125
|
0.10%
5/5115
|
0.02%
1/5110
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.20%
10/5125
|
0.22%
11/5115
|
0.22%
11/5110
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.04%
2/5125
|
0.02%
1/5115
|
0.04%
2/5110
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Respiratory, thoracic and mediastinal disorders
Vocal Cord Polyp
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Skin and subcutaneous tissue disorders
Haemorrhage Subcutaneous
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein Purpura
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Skin and subcutaneous tissue disorders
Rash Generalised
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Social circumstances
Cardiac Valve Prosthesis User
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Social circumstances
Prosthesis User
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Surgical and medical procedures
Angioplasty
|
0.00%
0/5125
|
0.06%
3/5115
|
0.00%
0/5110
|
|
Surgical and medical procedures
Aortic Aneurysm Repair
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Surgical and medical procedures
Aortic Valve Replacement
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Surgical and medical procedures
Arterial Repair
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Surgical and medical procedures
Arteriovenous Shunt Operation
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Surgical and medical procedures
Bladder Neoplasm Surgery
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Surgical and medical procedures
Cardiac Ablation
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Surgical and medical procedures
Cardiac Pacemaker Insertion
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Surgical and medical procedures
Carotid Endarterectomy
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Surgical and medical procedures
Cataract Operation
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/5125
|
0.04%
2/5115
|
0.04%
2/5110
|
|
Surgical and medical procedures
Coronary Angioplasty
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Surgical and medical procedures
Coronary Arterial Stent Insertion
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Surgical and medical procedures
Coronary Artery Bypass
|
0.06%
3/5125
|
0.06%
3/5115
|
0.12%
6/5110
|
|
Surgical and medical procedures
Coronary Revascularisation
|
0.04%
2/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Surgical and medical procedures
Foot Amputation
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Surgical and medical procedures
Gastric Banding
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Surgical and medical procedures
Gastric Bypass
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Surgical and medical procedures
Glaucoma Surgery
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Surgical and medical procedures
Hernia Repair
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Surgical and medical procedures
Hip Arthroplasty
|
0.04%
2/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Surgical and medical procedures
Implantable Defibrillator Insertion
|
0.00%
0/5125
|
0.02%
1/5115
|
0.04%
2/5110
|
|
Surgical and medical procedures
Inguinal Hernia Repair
|
0.02%
1/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Surgical and medical procedures
Knee Arthroplasty
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Surgical and medical procedures
Knee Operation
|
0.02%
1/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Surgical and medical procedures
Leg Amputation
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Surgical and medical procedures
Meniscus Operation
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Surgical and medical procedures
Orthopedic Procedure
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Surgical and medical procedures
Pancreas Transplant
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Surgical and medical procedures
Percutaneous Coronary Intervention
|
0.10%
5/5125
|
0.20%
10/5115
|
0.16%
8/5110
|
|
Surgical and medical procedures
Polypectomy
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Surgical and medical procedures
Prostatectomy
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Surgical and medical procedures
Rehabilitation Therapy
|
0.04%
2/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Surgical and medical procedures
Shoulder Operation
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Surgical and medical procedures
Spinal Laminectomy
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Surgical and medical procedures
Thyroidectomy
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Surgical and medical procedures
Tooth Extraction
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Surgical and medical procedures
Tracheostomy Tube Removal
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Surgical and medical procedures
Transurethral Prostatectomy
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Surgical and medical procedures
Vitrectomy
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Vascular disorders
Angiopathy
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Vascular disorders
Aortic Aneurysm
|
0.08%
4/5125
|
0.04%
2/5115
|
0.04%
2/5110
|
|
Vascular disorders
Aortic Dissection
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Vascular disorders
Aortic Stenosis
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Vascular disorders
Arterial Disorder
|
0.00%
0/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Vascular disorders
Arterial Thrombosis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Vascular disorders
Arterial Thrombosis Limb
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Vascular disorders
Arteriosclerosis
|
0.04%
2/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Vascular disorders
Arteriosclerosis Obliterans
|
0.04%
2/5125
|
0.02%
1/5115
|
0.04%
2/5110
|
|
Vascular disorders
Arteriovenous Fistula
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Vascular disorders
Arteritis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Vascular disorders
Artery Dissection
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Vascular disorders
Blue Toe Syndrome
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Vascular disorders
Circulatory Collapse
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.02%
1/5125
|
0.02%
1/5115
|
0.02%
1/5110
|
|
Vascular disorders
Diabetic Vascular Disorder
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Vascular disorders
Embolism
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Vascular disorders
Extremity Necrosis
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Vascular disorders
Femoral Arterial Stenosis
|
0.04%
2/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Vascular disorders
Femoral Artery Embolism
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Vascular disorders
Femoral Artery Occlusion
|
0.00%
0/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Vascular disorders
Flushing
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Vascular disorders
Haematoma
|
0.04%
2/5125
|
0.14%
7/5115
|
0.12%
6/5110
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Vascular disorders
Hypertension
|
0.16%
8/5125
|
0.31%
16/5115
|
0.12%
6/5110
|
|
Vascular disorders
Hypertensive Crisis
|
0.20%
10/5125
|
0.16%
8/5115
|
0.27%
14/5110
|
|
Vascular disorders
Hypertensive Emergency
|
0.06%
3/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Vascular disorders
Hypotension
|
0.06%
3/5125
|
0.10%
5/5115
|
0.10%
5/5110
|
|
Vascular disorders
Hypovolaemic Shock
|
0.02%
1/5125
|
0.02%
1/5115
|
0.00%
0/5110
|
|
Vascular disorders
Iliac Artery Occlusion
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Vascular disorders
Intermittent Claudication
|
0.06%
3/5125
|
0.02%
1/5115
|
0.06%
3/5110
|
|
Vascular disorders
Intra-Abdominal Haemorrhage
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Vascular disorders
Ischaemia
|
0.04%
2/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Vascular disorders
Leriche Syndrome
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Vascular disorders
Orthostatic Hypotension
|
0.02%
1/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.08%
4/5125
|
0.06%
3/5115
|
0.10%
5/5110
|
|
Vascular disorders
Peripheral Artery Aneurysm
|
0.02%
1/5125
|
0.00%
0/5115
|
0.04%
2/5110
|
|
Vascular disorders
Peripheral Embolism
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Vascular disorders
Peripheral Ischaemia
|
0.02%
1/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.06%
3/5125
|
0.04%
2/5115
|
0.02%
1/5110
|
|
Vascular disorders
Phlebitis
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Vascular disorders
Shock
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Vascular disorders
Thrombosis
|
0.02%
1/5125
|
0.04%
2/5115
|
0.00%
0/5110
|
|
Vascular disorders
Varicose Vein
|
0.02%
1/5125
|
0.00%
0/5115
|
0.00%
0/5110
|
|
Vascular disorders
Vasospasm
|
0.00%
0/5125
|
0.00%
0/5115
|
0.02%
1/5110
|
Other adverse events
| Measure |
Placebo
n=5125 participants at risk
One placebo tablet twice daily
|
Rivaroxaban 2.5 mg Bid
n=5115 participants at risk
One rivaroxaban 2.5 mg tablet twice daily
|
Rivaroxaban 5 mg Bid
n=5110 participants at risk
One rivaroxaban 5 mg tablet twice daily
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.7%
140/5125
|
5.1%
259/5115
|
6.7%
341/5110
|
Additional Information
Development Head Cardiovascular/Urology
Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Phone: 1 215 628-5257
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER