Trial Outcomes & Findings for An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation (NCT NCT00403767)
NCT ID: NCT00403767
Last Updated: 2014-04-29
Results Overview
The number of patients with the first occurrence of a stroke or non-CNS systemic embolism while on treatment (defined as the time interval from the first dose to the last dose of study drug plus 2 days). The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
14269 participants
Primary outcome timeframe
Up to 4 years
Results posted on
2014-04-29
Participant Flow
This study, an efficacy and safety study of Rivaroxaban with Warfarin for the prevention of stroke and non-central nervous system systemic embolism in patients with non-valvular atrial fibrillation, was conducted from 18 December 2006 to 07 September 2010. Patients were recruited at 1,170 study centers located in 45 countries worldwide.
A total of 14,269 patients were randomized in the study. Five patients were randomized twice bringing the number of randomized unique patients to 14,264. A total of 14,236 (7111 and 7125 patients in the rivaroxaban and warfarin groups, respectively) unique patients took at least 1 dose of study medication and were included in the Safety Population.
Participant milestones
| Measure |
Rivaroxaban
Rivaroxaban 15 mg p.o. once daily or Rivaroxaban 20 mg p.o. once daily
|
Warfarin
Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
|
|---|---|---|
|
Overall Study
STARTED
|
7111
|
7125
|
|
Overall Study
COMPLETED
|
4591
|
4657
|
|
Overall Study
NOT COMPLETED
|
2520
|
2468
|
Reasons for withdrawal
| Measure |
Rivaroxaban
Rivaroxaban 15 mg p.o. once daily or Rivaroxaban 20 mg p.o. once daily
|
Warfarin
Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
|
|---|---|---|
|
Overall Study
Adverse Event
|
993
|
919
|
|
Overall Study
Non-compliant with study medication
|
134
|
164
|
|
Overall Study
Consent withdrawn
|
671
|
673
|
|
Overall Study
Investigator dec./not protocol-related
|
191
|
178
|
|
Overall Study
Lost to Follow-up
|
6
|
8
|
|
Overall Study
Protocol Violation
|
142
|
124
|
|
Overall Study
Clinical efficacy endpoint reached
|
300
|
332
|
|
Overall Study
Study terminated by sponsor
|
82
|
69
|
|
Overall Study
Missing/incomplete data
|
1
|
1
|
Baseline Characteristics
An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Rivaroxaban
n=7111 Participants
Rivaroxaban 15 mg p.o. once daily or Rivaroxaban 20 mg p.o. once daily
|
Warfarin
n=7125 Participants
Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
|
Total
n=14236 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
|
|
Age, Categorical
Between 18 and 65 years
|
1646 Participants
n=5 Participants
|
1642 Participants
n=7 Participants
|
3288 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5465 Participants
n=5 Participants
|
5483 Participants
n=7 Participants
|
10948 Participants
n=5 Participants
|
|
Age, Continuous
Age Continuous
|
71.2 years
STANDARD_DEVIATION 9.45 • n=5 Participants
|
71.2 years
STANDARD_DEVIATION 9.39 • n=7 Participants
|
71.2 years
STANDARD_DEVIATION 9.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2819 Participants
n=5 Participants
|
2826 Participants
n=7 Participants
|
5645 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4292 Participants
n=5 Participants
|
4299 Participants
n=7 Participants
|
8591 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
284 participants
n=5 Participants
|
285 participants
n=7 Participants
|
569 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
120 participants
n=5 Participants
|
122 participants
n=7 Participants
|
242 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
49 participants
n=5 Participants
|
47 participants
n=7 Participants
|
96 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
241 participants
n=5 Participants
|
242 participants
n=7 Participants
|
483 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
337 participants
n=5 Participants
|
339 participants
n=7 Participants
|
676 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
372 participants
n=5 Participants
|
375 participants
n=7 Participants
|
747 participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
144 participants
n=5 Participants
|
142 participants
n=7 Participants
|
286 participants
n=5 Participants
|
|
Region of Enrollment
China
|
249 participants
n=5 Participants
|
246 participants
n=7 Participants
|
495 participants
n=5 Participants
|
|
Region of Enrollment
Colombia
|
134 participants
n=5 Participants
|
133 participants
n=7 Participants
|
267 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
299 participants
n=5 Participants
|
299 participants
n=7 Participants
|
598 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
60 participants
n=5 Participants
|
61 participants
n=7 Participants
|
121 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
France
|
35 participants
n=5 Participants
|
36 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
263 participants
n=5 Participants
|
265 participants
n=7 Participants
|
528 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
119 participants
n=5 Participants
|
118 participants
n=7 Participants
|
237 participants
n=5 Participants
|
|
Region of Enrollment
India
|
133 participants
n=5 Participants
|
135 participants
n=7 Participants
|
268 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
94 participants
n=5 Participants
|
94 participants
n=7 Participants
|
188 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
69 participants
n=5 Participants
|
69 participants
n=7 Participants
|
138 participants
n=5 Participants
|
|
Region of Enrollment
Korea (South)
|
103 participants
n=5 Participants
|
100 participants
n=7 Participants
|
203 participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
122 participants
n=5 Participants
|
122 participants
n=7 Participants
|
244 participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
26 participants
n=5 Participants
|
25 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
83 participants
n=5 Participants
|
85 participants
n=7 Participants
|
168 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
80 participants
n=5 Participants
|
81 participants
n=7 Participants
|
161 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
58 participants
n=5 Participants
|
58 participants
n=7 Participants
|
116 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
25 participants
n=5 Participants
|
24 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Region of Enrollment
Peru
|
42 participants
n=5 Participants
|
42 participants
n=7 Participants
|
84 participants
n=5 Participants
|
|
Region of Enrollment
Philippines
|
185 participants
n=5 Participants
|
183 participants
n=7 Participants
|
368 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
263 participants
n=5 Participants
|
264 participants
n=7 Participants
|
527 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
391 participants
n=5 Participants
|
391 participants
n=7 Participants
|
782 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
645 participants
n=5 Participants
|
645 participants
n=7 Participants
|
1290 participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
21 participants
n=5 Participants
|
23 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
122 participants
n=5 Participants
|
125 participants
n=7 Participants
|
247 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
124 participants
n=5 Participants
|
124 participants
n=7 Participants
|
248 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
78 participants
n=5 Participants
|
79 participants
n=7 Participants
|
157 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
43 participants
n=5 Participants
|
44 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
50 participants
n=5 Participants
|
51 participants
n=7 Participants
|
101 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
505 participants
n=5 Participants
|
504 participants
n=7 Participants
|
1009 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
79 participants
n=5 Participants
|
80 participants
n=7 Participants
|
159 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
962 participants
n=5 Participants
|
964 participants
n=7 Participants
|
1926 participants
n=5 Participants
|
|
Region of Enrollment
Venezuela
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
36 participants
n=5 Participants
|
37 participants
n=7 Participants
|
73 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 4 yearsPopulation: The per-protocol (PP) population consisted of all randomized unique patients excluding those who had specific pre-defined major protocol deviations that occurred by the time of enrollment into the study or during the trial. Site 042012 with GCP violation was excluded.
The number of patients with the first occurrence of a stroke or non-CNS systemic embolism while on treatment (defined as the time interval from the first dose to the last dose of study drug plus 2 days). The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.
Outcome measures
| Measure |
Rivaroxaban
n=6958 Participants
Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 - 49 mL/min. at baseline)
|
Warfarin
n=7004 Participants
Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
|
|---|---|---|
|
The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority)
|
188 Patients
|
241 Patients
|
PRIMARY outcome
Timeframe: Up to 4 yearsPopulation: The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.
The number of patients with the first occurrence of a stroke or non-CNS systemic embolism while on treatment (defined as the time interval from the first dose to the last dose of study drug plus 2 days). The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.
Outcome measures
| Measure |
Rivaroxaban
n=7061 Participants
Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 - 49 mL/min. at baseline)
|
Warfarin
n=7082 Participants
Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
|
|---|---|---|
|
The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority)
|
189 Patients
|
243 Patients
|
PRIMARY outcome
Timeframe: Up to 4 yearsPopulation: The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period.
The number of patients with the first occurrence of a major or non-major clinically relevant bleeding event while on treatment. The statistical analysis is based on time from the first dose of study drug to the first occurrence of the event while on treatment.
Outcome measures
| Measure |
Rivaroxaban
n=7111 Participants
Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 - 49 mL/min. at baseline)
|
Warfarin
n=7125 Participants
Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
|
|---|---|---|
|
The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety
|
1475 Patients
|
1449 Patients
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.
The number of patients with the first occurrence of a stroke, non-CNS systemic embolism, or vascular death while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.
Outcome measures
| Measure |
Rivaroxaban
n=7061 Participants
Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 - 49 mL/min. at baseline)
|
Warfarin
n=7125 Participants
Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
|
|---|---|---|
|
The Composite Event of Stroke/Non-CNS Systemic Embolism/Vascular Death
|
346 Patients
|
410 Patients
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.
The number of patients with the first occurrence of a stroke, non-CNS systemic embolism, myocardial infarction, or vascular death while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.
Outcome measures
| Measure |
Rivaroxaban
n=7061 Participants
Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 - 49 mL/min. at baseline)
|
Warfarin
n=7082 Participants
Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
|
|---|---|---|
|
The Composite Event of Stroke/Non-CNS Systemic Embolism/Myocardial Infarction/Vascular Death
|
433 Patients
|
519 Patients
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.
The number of patients with the first occurrence of a stroke while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.
Outcome measures
| Measure |
Rivaroxaban
n=7061 Participants
Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 - 49 mL/min. at baseline)
|
Warfarin
n=7082 Participants
Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
|
|---|---|---|
|
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Stroke
|
184 Patients
|
221 Patients
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.
The number of patients with the first occurrence of a non-CNS systemic embolism while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.
Outcome measures
| Measure |
Rivaroxaban
n=7061 Participants
Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 - 49 mL/min. at baseline)
|
Warfarin
n=7082 Participants
Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
|
|---|---|---|
|
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Non-CNS Systemic Embolism
|
5 Patients
|
22 Patients
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.
The number of patients with the first occurrence of a myocardial infarction while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.
Outcome measures
| Measure |
Rivaroxaban
n=7061 Participants
Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 - 49 mL/min. at baseline)
|
Warfarin
n=7082 Participants
Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
|
|---|---|---|
|
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Myocardial Infarction
|
101 Patients
|
126 Patients
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.
The number of patients with the occurrence of vascular death while on treatment. The statistical analysis is based on time from randomization to the event while on treatment.
Outcome measures
| Measure |
Rivaroxaban
n=7061 Participants
Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 - 49 mL/min. at baseline)
|
Warfarin
n=7082 Participants
Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
|
|---|---|---|
|
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Vascular Death
|
170 Patients
|
193 Patients
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.
The number of patients who died due to any cause while on treatment. The statistical analysis is based on time from randomization to the event while on treatment.
Outcome measures
| Measure |
Rivaroxaban
n=7061 Participants
Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 - 49 mL/min. at baseline)
|
Warfarin
n=7125 Participants
Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
|
|---|---|---|
|
All-cause Mortality
|
208 Patients
|
250 Patients
|
Adverse Events
Rivaroxaban
Serious events: 2649 serious events
Other events: 2537 other events
Deaths: 0 deaths
Warfarin
Serious events: 2720 serious events
Other events: 2573 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rivaroxaban
n=7111 participants at risk
Rivaroxaban 15 mg p.o. once daily or Rivaroxaban 20 mg p.o. once daily
|
Warfarin
n=7125 participants at risk
Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.15%
11/7111
|
0.13%
9/7125
|
|
Nervous system disorders
Partial Seizures
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Blood and lymphatic system disorders
Anaemia
|
0.96%
68/7111
|
0.44%
31/7125
|
|
Blood and lymphatic system disorders
Anaemia Haemolytic Autoimmune
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Blood and lymphatic system disorders
Anaemia Vitamin B12 Deficiency
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Blood and lymphatic system disorders
Anaemia of Malignant Disease
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Blood and lymphatic system disorders
Haemolytic Anaemia
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Blood and lymphatic system disorders
Haemorrhagic Anaemia
|
0.07%
5/7111
|
0.07%
5/7125
|
|
Blood and lymphatic system disorders
Hypochromic Anaemia
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Blood and lymphatic system disorders
Hypocoagulable State
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Blood and lymphatic system disorders
Hypoplastic Anaemia
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Blood and lymphatic system disorders
Idiopathic Thrombocytopenic Purpura
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.23%
16/7111
|
0.08%
6/7125
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Blood and lymphatic system disorders
Microcytic Anaemia
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Blood and lymphatic system disorders
Nephrogenic Anaemia
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Blood and lymphatic system disorders
Normochromic Normocytic Anaemia
|
0.04%
3/7111
|
0.06%
4/7125
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Blood and lymphatic system disorders
Splenic Infarction
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.08%
6/7111
|
0.04%
3/7125
|
|
Blood and lymphatic system disorders
Thrombocytopenic Purpura
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.07%
5/7111
|
0.11%
8/7125
|
|
Cardiac disorders
Acute Left Ventricular Failure
|
0.07%
5/7111
|
0.06%
4/7125
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.08%
6/7111
|
0.15%
11/7125
|
|
Cardiac disorders
Acute Right Ventricular Failure
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Adams-Stokes Syndrome
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Cardiac disorders
Angina Pectoris
|
0.44%
31/7111
|
0.46%
33/7125
|
|
Cardiac disorders
Angina Unstable
|
1.0%
74/7111
|
1.3%
92/7125
|
|
Cardiac disorders
Aortic Valve Disease
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Aortic Valve Disease Mixed
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Cardiac disorders
Aortic Valve Incompetence
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.06%
4/7111
|
0.11%
8/7125
|
|
Cardiac disorders
Arrhythmia
|
0.13%
9/7111
|
0.08%
6/7125
|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.10%
7/7111
|
0.04%
3/7125
|
|
Cardiac disorders
Atrial Fibrillation
|
2.2%
158/7111
|
2.3%
161/7125
|
|
Cardiac disorders
Atrial Flutter
|
0.14%
10/7111
|
0.24%
17/7125
|
|
Cardiac disorders
Atrial Tachycardia
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Atrial Thrombosis
|
0.03%
2/7111
|
0.04%
3/7125
|
|
Cardiac disorders
Atrioventricular Block
|
0.03%
2/7111
|
0.06%
4/7125
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.17%
12/7111
|
0.13%
9/7125
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Cardiac disorders
Bradyarrhythmia
|
0.04%
3/7111
|
0.04%
3/7125
|
|
Cardiac disorders
Bradycardia
|
0.49%
35/7111
|
0.32%
23/7125
|
|
Cardiac disorders
Cardiac Amyloidosis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Cardiac disorders
Cardiac Arrest
|
0.21%
15/7111
|
0.46%
33/7125
|
|
Cardiac disorders
Cardiac Asthma
|
0.04%
3/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Cardiac Disorder
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Cardiac Failure
|
4.0%
283/7111
|
4.3%
309/7125
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.56%
40/7111
|
0.51%
36/7125
|
|
Cardiac disorders
Cardiac Failure Chronic
|
0.37%
26/7111
|
0.60%
43/7125
|
|
Cardiac disorders
Cardiac Failure Congestive
|
2.5%
178/7111
|
2.9%
206/7125
|
|
Cardiac disorders
Cardiac Tamponade
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Cardiac disorders
Cardiac Valve Disease
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.10%
7/7111
|
0.14%
10/7125
|
|
Cardiac disorders
Cardiogenic Shock
|
0.20%
14/7111
|
0.14%
10/7125
|
|
Cardiac disorders
Cardiomyopathy
|
0.04%
3/7111
|
0.08%
6/7125
|
|
Cardiac disorders
Cardiopulmonary Failure
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Cardiovascular Insufficiency
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Cardiac disorders
Congestive Cardiomyopathy
|
0.04%
3/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Cor Pulmonale
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Cardiac disorders
Coronary Artery Disease
|
0.41%
29/7111
|
0.46%
33/7125
|
|
Cardiac disorders
Coronary Artery Insufficiency
|
0.01%
1/7111
|
0.04%
3/7125
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.01%
1/7111
|
0.04%
3/7125
|
|
Cardiac disorders
Electromechanical Dissociation
|
0.04%
3/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Heart Valve Stenosis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Hypertensive Heart Disease
|
0.04%
3/7111
|
0.00%
0/7125
|
|
Cardiac disorders
Hypertrophic Cardiomyopathy
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
0.03%
2/7111
|
0.04%
3/7125
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
0.04%
3/7111
|
0.03%
2/7125
|
|
Cardiac disorders
Left Ventricular Failure
|
0.15%
11/7111
|
0.17%
12/7125
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.10%
7/7111
|
0.08%
6/7125
|
|
Cardiac disorders
Myocardial Infarction
|
0.27%
19/7111
|
0.31%
22/7125
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.08%
6/7111
|
0.08%
6/7125
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Nodal Arrhythmia
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Cardiac disorders
Nodal Rhythm
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Cardiac disorders
Palpitations
|
0.03%
2/7111
|
0.04%
3/7125
|
|
Cardiac disorders
Pericardial Effusion
|
0.06%
4/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Pericardial Haemorrhage
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Pericarditis
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Right Ventricular Failure
|
0.06%
4/7111
|
0.03%
2/7125
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.52%
37/7111
|
0.35%
25/7125
|
|
Cardiac disorders
Sinus Arrest
|
0.04%
3/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Sinus Arrhythmia
|
0.06%
4/7111
|
0.06%
4/7125
|
|
Cardiac disorders
Sinus Bradycardia
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Supraventricular Extrasystoles
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Tachyarrhythmia
|
0.14%
10/7111
|
0.04%
3/7125
|
|
Cardiac disorders
Tachycardia
|
0.08%
6/7111
|
0.11%
8/7125
|
|
Cardiac disorders
Tachycardia Paroxysmal
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Torsade De Pointes
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.01%
1/7111
|
0.06%
4/7125
|
|
Cardiac disorders
Ventricular Asystole
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Ventricular Dysfunction
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.01%
1/7111
|
0.04%
3/7125
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.25%
18/7111
|
0.18%
13/7125
|
|
Cardiac disorders
Ventricular Tachyarrhythmia
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.23%
16/7111
|
0.27%
19/7125
|
|
Congenital, familial and genetic disorders
Gastrointestinal Angiodysplasia Haemorrhagic
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.04%
3/7111
|
0.06%
4/7125
|
|
Congenital, familial and genetic disorders
Pyloric Stenosis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Ear and labyrinth disorders
Ear Haemorrhage
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Ear and labyrinth disorders
External Ear Inflammation
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Ear and labyrinth disorders
Inner Ear Disorder
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Ear and labyrinth disorders
Meniere's Disease
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Ear and labyrinth disorders
Sudden Hearing Loss
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Ear and labyrinth disorders
Vertigo
|
0.14%
10/7111
|
0.14%
10/7125
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Ear and labyrinth disorders
Vestibular Disorder
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Endocrine disorders
Cushing's Syndrome
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Endocrine disorders
Goitre
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Endocrine disorders
Hyperthyroidism
|
0.08%
6/7111
|
0.00%
0/7125
|
|
Endocrine disorders
Hypothyroidism
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Endocrine disorders
Primary Hyperaldosteronism
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Eye disorders
Amaurosis Fugax
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Eye disorders
Angle Closure Glaucoma
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Eye disorders
Cataract
|
0.18%
13/7111
|
0.44%
31/7125
|
|
Eye disorders
Cataract Diabetic
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Eye disorders
Chorioretinal Atrophy
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Eye disorders
Conjunctival Haemorrhage
|
0.01%
1/7111
|
0.04%
3/7125
|
|
Eye disorders
Dacryostenosis Acquired
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Eye disorders
Diabetic Retinopathy
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Eye disorders
Eye Haemorrhage
|
0.06%
4/7111
|
0.03%
2/7125
|
|
Eye disorders
Glaucoma
|
0.06%
4/7111
|
0.03%
2/7125
|
|
Eye disorders
Glaucomatocyclitic Crises
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Eye disorders
Hyphaema
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Eye disorders
Keratopathy
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Eye disorders
Macular Degeneration
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Eye disorders
Macular Hole
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Eye disorders
Macular Oedema
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Eye disorders
Open Angle Glaucoma
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Eye disorders
Retinal Artery Thrombosis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Eye disorders
Retinal Detachment
|
0.03%
2/7111
|
0.07%
5/7125
|
|
Eye disorders
Retinal Haemorrhage
|
0.03%
2/7111
|
0.04%
3/7125
|
|
Eye disorders
Retinal Vein Occlusion
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Eye disorders
Retinal Vein Thrombosis
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Eye disorders
Retinopathy Haemorrhagic
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Eye disorders
Retinoschisis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Eye disorders
Scleral Haemorrhage
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Eye disorders
Strabismus
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Eye disorders
Ulcerative Keratitis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Eye disorders
Uveitis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Eye disorders
Vitreous Degeneration
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Eye disorders
Vitreous Haemorrhage
|
0.04%
3/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Abdominal Adhesions
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Gastrointestinal disorders
Abdominal Hernia Obstructive
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Gastrointestinal disorders
Abdominal Mass
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.14%
10/7111
|
0.07%
5/7125
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Gastrointestinal disorders
Abdominal Strangulated Hernia
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Gastrointestinal disorders
Abdominal Wall Haematoma
|
0.01%
1/7111
|
0.06%
4/7125
|
|
Gastrointestinal disorders
Acute Abdomen
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Gastrointestinal disorders
Anal Fistula
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Gastrointestinal disorders
Anal Haemorrhage
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Ascites
|
0.03%
2/7111
|
0.06%
4/7125
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Colonic Obstruction
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Colonic Polyp
|
0.13%
9/7111
|
0.11%
8/7125
|
|
Gastrointestinal disorders
Constipation
|
0.11%
8/7111
|
0.08%
6/7125
|
|
Gastrointestinal disorders
Dental Caries
|
0.07%
5/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Diverticular Perforation
|
0.01%
1/7111
|
0.04%
3/7125
|
|
Gastrointestinal disorders
Diverticulitis Intestinal Haemorrhagic
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
0.01%
1/7111
|
0.06%
4/7125
|
|
Gastrointestinal disorders
Diverticulum Intestinal Haemorrhagic
|
0.00%
0/7111
|
0.04%
3/7125
|
|
Gastrointestinal disorders
Duodenal Polyp
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.06%
4/7111
|
0.04%
3/7125
|
|
Gastrointestinal disorders
Duodenal Ulcer Haemorrhage
|
0.06%
4/7111
|
0.06%
4/7125
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Dyspepsia
|
0.08%
6/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Enteritis
|
0.01%
1/7111
|
0.04%
3/7125
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Gastrointestinal disorders
Enterocolitis Haemorrhagic
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Faecaloma
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Faeces Discoloured
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Femoral Hernia, Obstructive
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
0.13%
9/7111
|
0.10%
7/7125
|
|
Gastrointestinal disorders
Gastric Polyps
|
0.06%
4/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.03%
2/7111
|
0.06%
4/7125
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.15%
11/7111
|
0.13%
9/7125
|
|
Gastrointestinal disorders
Gastric Varices
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Gastric Varices Haemorrhage
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Gastritis
|
0.14%
10/7111
|
0.06%
4/7125
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.03%
2/7111
|
0.13%
9/7125
|
|
Gastrointestinal disorders
Gastritis Haemorrhagic
|
0.10%
7/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Gastroduodenal Haemorrhage
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Gastroduodenal Ulcer
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.2%
88/7111
|
0.87%
62/7125
|
|
Gastrointestinal disorders
Gastrointestinal Ischaemia
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Gastrointestinal Motility Disorder
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Gastrointestinal Ulcer
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.06%
4/7111
|
0.06%
4/7125
|
|
Gastrointestinal disorders
Gastrooesophagitis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.07%
5/7111
|
0.04%
3/7125
|
|
Gastrointestinal disorders
Haematemesis
|
0.04%
3/7111
|
0.06%
4/7125
|
|
Gastrointestinal disorders
Haematochezia
|
0.04%
3/7111
|
0.06%
4/7125
|
|
Gastrointestinal disorders
Haemorrhagic Erosive Gastritis
|
0.06%
4/7111
|
0.07%
5/7125
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.08%
6/7111
|
0.06%
4/7125
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.10%
7/7111
|
0.06%
4/7125
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Gastrointestinal disorders
Ileus
|
0.07%
5/7111
|
0.06%
4/7125
|
|
Gastrointestinal disorders
Ileus Paralytic
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Inflammatory Bowel Disease
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.41%
29/7111
|
0.29%
21/7125
|
|
Gastrointestinal disorders
Inguinal Hernia Strangulated
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Inguinal Hernia, Obstructive
|
0.04%
3/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Intestinal Cyst
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Intestinal Dilatation
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Intestinal Haemorrhage
|
0.06%
4/7111
|
0.06%
4/7125
|
|
Gastrointestinal disorders
Intestinal Infarction
|
0.03%
2/7111
|
0.04%
3/7125
|
|
Gastrointestinal disorders
Intestinal Ischaemia
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.06%
4/7111
|
0.08%
6/7125
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Intestinal Polyp
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Intestinal Strangulation
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Intra-Abdominal Haematoma
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Intra-Abdominal Haemorrhage
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Gastrointestinal disorders
Large Intestinal Haemorrhage
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Large Intestinal Obstruction
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.27%
19/7111
|
0.21%
15/7125
|
|
Gastrointestinal disorders
Lumbar Hernia
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Mallory-Weiss Syndrome
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Mechanical Ileus
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Melaena
|
0.41%
29/7111
|
0.25%
18/7125
|
|
Gastrointestinal disorders
Mesenteric Artery Thrombosis
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Gastrointestinal disorders
Mesenteric Vein Thrombosis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Mouth Haemorrhage
|
0.03%
2/7111
|
0.06%
4/7125
|
|
Gastrointestinal disorders
Nausea
|
0.04%
3/7111
|
0.03%
2/7125
|
|
Gastrointestinal disorders
Oesophageal Disorder
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Oesophageal Haemorrhage
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Oesophageal Rupture
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Oesophageal Spasm
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Oesophageal Stenosis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Oesophageal Ulcer
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Oesophageal Varices Haemorrhage
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Oesophagitis Haemorrhagic
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Pancreatic Cyst
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Pancreatic Mass
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Pancreatitis
|
0.08%
6/7111
|
0.03%
2/7125
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.10%
7/7111
|
0.08%
6/7125
|
|
Gastrointestinal disorders
Pancreatitis Haemorrhagic
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Pancreatitis Relapsing
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Peptic Ulcer
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Peptic Ulcer Haemorrhage
|
0.04%
3/7111
|
0.06%
4/7125
|
|
Gastrointestinal disorders
Peritoneal Necrosis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Peritonitis
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.34%
24/7111
|
0.36%
26/7125
|
|
Gastrointestinal disorders
Rectal Polyp
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Gastrointestinal disorders
Rectal Ulcer
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Rectal Ulcer Haemorrhage
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Retroperitoneal Haematoma
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Gastrointestinal disorders
Retroperitoneal Haemorrhage
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Small Intestinal Haemorrhage
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.03%
2/7111
|
0.06%
4/7125
|
|
Gastrointestinal disorders
Subileus
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Gastrointestinal disorders
Tongue Haemorrhage
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.01%
1/7111
|
0.04%
3/7125
|
|
Gastrointestinal disorders
Umbilical Hernia, Obstructive
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.75%
53/7111
|
0.48%
34/7125
|
|
Gastrointestinal disorders
Varices Oesophageal
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Volvulus
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Vomiting
|
0.04%
3/7111
|
0.04%
3/7125
|
|
General disorders
Asthenia
|
0.06%
4/7111
|
0.04%
3/7125
|
|
General disorders
Cardiac Death
|
0.00%
0/7111
|
0.03%
2/7125
|
|
General disorders
Catheter Site Haemorrhage
|
0.01%
1/7111
|
0.00%
0/7125
|
|
General disorders
Chest Discomfort
|
0.00%
0/7111
|
0.06%
4/7125
|
|
General disorders
Chest Pain
|
0.52%
37/7111
|
0.62%
44/7125
|
|
General disorders
Chills
|
0.01%
1/7111
|
0.00%
0/7125
|
|
General disorders
Death
|
0.27%
19/7111
|
0.32%
23/7125
|
|
General disorders
Device Capturing Issue
|
0.01%
1/7111
|
0.00%
0/7125
|
|
General disorders
Device Dislocation
|
0.03%
2/7111
|
0.01%
1/7125
|
|
General disorders
Device Lead Damage
|
0.01%
1/7111
|
0.00%
0/7125
|
|
General disorders
Device Malfunction
|
0.08%
6/7111
|
0.07%
5/7125
|
|
General disorders
Device Occlusion
|
0.06%
4/7111
|
0.00%
0/7125
|
|
General disorders
Device Power Source Issue
|
0.01%
1/7111
|
0.01%
1/7125
|
|
General disorders
Gait Disturbance
|
0.01%
1/7111
|
0.01%
1/7125
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/7111
|
0.04%
3/7125
|
|
General disorders
Generalised Oedema
|
0.04%
3/7111
|
0.01%
1/7125
|
|
General disorders
Hernia
|
0.00%
0/7111
|
0.03%
2/7125
|
|
General disorders
Hernia Pain
|
0.01%
1/7111
|
0.00%
0/7125
|
|
General disorders
Hyperthermia
|
0.00%
0/7111
|
0.01%
1/7125
|
|
General disorders
Impaired Healing
|
0.01%
1/7111
|
0.01%
1/7125
|
|
General disorders
Implant Site Haemorrhage
|
0.00%
0/7111
|
0.01%
1/7125
|
|
General disorders
Implant Site Reaction
|
0.00%
0/7111
|
0.01%
1/7125
|
|
General disorders
Injury Associated with Device
|
0.00%
0/7111
|
0.01%
1/7125
|
|
General disorders
Malaise
|
0.00%
0/7111
|
0.04%
3/7125
|
|
General disorders
Medical Device Complication
|
0.03%
2/7111
|
0.01%
1/7125
|
|
General disorders
Multi-Organ Failure
|
0.14%
10/7111
|
0.08%
6/7125
|
|
General disorders
Non-Cardiac Chest Pain
|
0.21%
15/7111
|
0.22%
16/7125
|
|
General disorders
Oedema
|
0.00%
0/7111
|
0.01%
1/7125
|
|
General disorders
Oedema Peripheral
|
0.07%
5/7111
|
0.06%
4/7125
|
|
General disorders
Pelvic Mass
|
0.00%
0/7111
|
0.01%
1/7125
|
|
General disorders
Pyrexia
|
0.04%
3/7111
|
0.08%
6/7125
|
|
General disorders
Sudden Cardiac Death
|
0.17%
12/7111
|
0.18%
13/7125
|
|
General disorders
Sudden Death
|
1.1%
80/7111
|
0.95%
68/7125
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
0.01%
1/7111
|
0.00%
0/7125
|
|
General disorders
Thrombosis in Device
|
0.00%
0/7111
|
0.01%
1/7125
|
|
General disorders
Vessel Puncture Site Haemorrhage
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Hepatobiliary disorders
Bile Duct Obstruction
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.07%
5/7111
|
0.10%
7/7125
|
|
Hepatobiliary disorders
Biliary Colic
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Hepatobiliary disorders
Cardiac Cirrhosis
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Hepatobiliary disorders
Cholangitis
|
0.10%
7/7111
|
0.03%
2/7125
|
|
Hepatobiliary disorders
Cholangitis Acute
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Hepatobiliary disorders
Cholangitis Sclerosing
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Hepatobiliary disorders
Cholecystitis
|
0.13%
9/7111
|
0.18%
13/7125
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.32%
23/7111
|
0.21%
15/7125
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.08%
6/7111
|
0.00%
0/7125
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.28%
20/7111
|
0.22%
16/7125
|
|
Hepatobiliary disorders
Cholelithiasis Obstructive
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Hepatobiliary disorders
Cryptogenic Cirrhosis
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Hepatobiliary disorders
Cytolytic Hepatitis
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Hepatobiliary disorders
Gallbladder Fistula
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
0.04%
3/7111
|
0.03%
2/7125
|
|
Hepatobiliary disorders
Hepatic Congestion
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Hepatobiliary disorders
Hepatic Haemorrhage
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Hepatobiliary disorders
Hepatitis
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Hepatobiliary disorders
Hepatitis Acute
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Hepatobiliary disorders
Ischaemic Hepatitis
|
0.01%
1/7111
|
0.04%
3/7125
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Hepatobiliary disorders
Jaundice Cholestatic
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Hepatobiliary disorders
Jaundice Hepatocellular
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Hepatobiliary disorders
Liver Disorder
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Hepatobiliary disorders
Portal Vein Thrombosis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Immune system disorders
Anaphylactic Reaction
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Immune system disorders
Anaphylactic Shock
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Immune system disorders
Drug Hypersensitivity
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Immune system disorders
Hypersensitivity
|
0.04%
3/7111
|
0.00%
0/7125
|
|
Immune system disorders
Skin Graft Rejection
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Abdominal Abscess
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Infections and infestations
Abscess
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Abscess Limb
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Infections and infestations
Abscess Neck
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Abscess of External Auditory Meatus
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Amoebiasis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Amoebic Dysentery
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Anal Abscess
|
0.04%
3/7111
|
0.00%
0/7125
|
|
Infections and infestations
Appendiceal Abscess
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Appendicitis
|
0.17%
12/7111
|
0.10%
7/7125
|
|
Infections and infestations
Appendicitis Perforated
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Infections and infestations
Arthritis Bacterial
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Infections and infestations
Arthritis Infective
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Infections and infestations
Bacteraemia
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Infections and infestations
Bacterial Infection
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Bacterial Pyelonephritis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Bacterial Sepsis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Blister Infected
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Breast Cellulitis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Bronchiectasis
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Infections and infestations
Bronchitis
|
0.53%
38/7111
|
0.45%
32/7125
|
|
Infections and infestations
Bronchitis Bacterial
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Infections and infestations
Bronchitis Viral
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Bronchopneumonia
|
0.15%
11/7111
|
0.17%
12/7125
|
|
Infections and infestations
Bursitis Infective Staphylococcal
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Cellulitis
|
0.59%
42/7111
|
0.90%
64/7125
|
|
Infections and infestations
Cellulitis Pharyngeal
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Cellulitis of Male External Genital Organ
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Cervicitis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Cholecystitis Infective
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Infections and infestations
Clostridial Infection
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Cystitis
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Infections and infestations
Dengue Fever
|
0.00%
0/7111
|
0.06%
4/7125
|
|
Infections and infestations
Device Related Infection
|
0.04%
3/7111
|
0.01%
1/7125
|
|
Infections and infestations
Diabetic Foot Infection
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Infections and infestations
Diabetic Gangrene
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Infections and infestations
Diarrhoea Infectious
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Diverticulitis
|
0.10%
7/7111
|
0.14%
10/7125
|
|
Infections and infestations
Ear Infection
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Empyema
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Encephalitis Herpes
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Endocarditis
|
0.04%
3/7111
|
0.00%
0/7125
|
|
Infections and infestations
Endocarditis Bacterial
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Enterococcal Bacteraemia
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Erysipelas
|
0.24%
17/7111
|
0.21%
15/7125
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Extradural Abscess
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Furuncle
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Gangrene
|
0.06%
4/7111
|
0.07%
5/7125
|
|
Infections and infestations
Gastroenteritis
|
0.25%
18/7111
|
0.53%
38/7125
|
|
Infections and infestations
Gastroenteritis Norovirus
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Infections and infestations
Gastroenteritis Salmonella
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Gastroenteritis Viral
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Gastrointestinal Infection
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Groin Abscess
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Haematoma Infection
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Infections and infestations
Helicobacter Gastritis
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Infections and infestations
Hepatitis B
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Infections and infestations
Hepatitis C
|
0.04%
3/7111
|
0.07%
5/7125
|
|
Infections and infestations
Hepatitis E
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Hepatitis Viral
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Herpes Zoster
|
0.08%
6/7111
|
0.08%
6/7125
|
|
Infections and infestations
Herpes Zoster Ophthalmic
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Herpes Zoster Oticus
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Implant Site Infection
|
0.04%
3/7111
|
0.03%
2/7125
|
|
Infections and infestations
Incision Site Abscess
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Infected Epidermal Cyst
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Infected Sebaceous Cyst
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Infected Skin Ulcer
|
0.04%
3/7111
|
0.01%
1/7125
|
|
Infections and infestations
Infection
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Infections and infestations
Infective Exacerbation of Chronic Obstructive Airways Disease
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Infections and infestations
Influenza
|
0.07%
5/7111
|
0.04%
3/7125
|
|
Infections and infestations
Infusion Site Infection
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Intertrigo Candida
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Intervertebral Discitis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Kidney Infection
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Infections and infestations
Labyrinthitis
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Infections and infestations
Laryngitis Bacterial
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Leptospirosis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Liver Abscess
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Lobar Pneumonia
|
0.23%
16/7111
|
0.18%
13/7125
|
|
Infections and infestations
Localised Infection
|
0.04%
3/7111
|
0.03%
2/7125
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.06%
4/7111
|
0.06%
4/7125
|
|
Infections and infestations
Lower Respiratory Tract Infection Viral
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Lung Infection
|
0.18%
13/7111
|
0.10%
7/7125
|
|
Infections and infestations
Lung Infection Pseudomonal
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Lyme Disease
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Malaria
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Meningitis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Meningitis Bacterial
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Meningitis Pneumococcal
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Meningitis Viral
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Nasal Abscess
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Neuroborreliosis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Oesophageal Candidiasis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Orchitis
|
0.04%
3/7111
|
0.01%
1/7125
|
|
Infections and infestations
Osteomyelitis
|
0.08%
6/7111
|
0.06%
4/7125
|
|
Infections and infestations
Otitis Externa
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Infections and infestations
Otitis Media
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Infections and infestations
Otitis Media Chronic
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Paronychia
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Infections and infestations
Parotitis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Pelvic Abscess
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Peridiverticular Abscess
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Perihepatic Abscess
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Perirectal Abscess
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Peritoneal Abscess
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Peritonsillar Abscess
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Infections and infestations
Periumbilical Abscess
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Pharyngitis
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Infections and infestations
Pneumococcal Sepsis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Pneumonia
|
2.2%
157/7111
|
2.8%
197/7125
|
|
Infections and infestations
Pneumonia Bacterial
|
0.07%
5/7111
|
0.08%
6/7125
|
|
Infections and infestations
Pneumonia Pneumococcal
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Pneumonia Staphylococcal
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Post Procedural Cellulitis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Post Procedural Infection
|
0.07%
5/7111
|
0.03%
2/7125
|
|
Infections and infestations
Postoperative Wound Infection
|
0.07%
5/7111
|
0.03%
2/7125
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Infections and infestations
Pyelonephritis
|
0.04%
3/7111
|
0.06%
4/7125
|
|
Infections and infestations
Pyelonephritis Acute
|
0.06%
4/7111
|
0.06%
4/7125
|
|
Infections and infestations
Pyelonephritis Chronic
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Pyoderma
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Pyothorax
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Rectal Abscess
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Respiratory Tract Infection
|
0.11%
8/7111
|
0.13%
9/7125
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Infections and infestations
Scrotal Infection
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Sepsis
|
0.39%
28/7111
|
0.41%
29/7125
|
|
Infections and infestations
Septic Shock
|
0.15%
11/7111
|
0.10%
7/7125
|
|
Infections and infestations
Sialoadenitis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Skin Bacterial Infection
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Infections and infestations
Staphylococcal Infection
|
0.01%
1/7111
|
0.04%
3/7125
|
|
Infections and infestations
Streptococcal Bacteraemia
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Infections and infestations
Streptococcal Sepsis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Subacute Endocarditis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Subcutaneous Abscess
|
0.01%
1/7111
|
0.04%
3/7125
|
|
Infections and infestations
Syphilis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Tooth Abscess
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Infections and infestations
Tracheobronchitis
|
0.01%
1/7111
|
0.06%
4/7125
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Tuberculous Pleurisy
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.10%
7/7111
|
0.17%
12/7125
|
|
Infections and infestations
Urinary Tract Infection
|
0.49%
35/7111
|
0.66%
47/7125
|
|
Infections and infestations
Urinary Tract Infection Bacterial
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Urinary Tract Infection Staphylococcal
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Infections and infestations
Urosepsis
|
0.11%
8/7111
|
0.15%
11/7125
|
|
Infections and infestations
Varicella
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Vestibular Neuronitis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Viral Infection
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Infections and infestations
Viral Labyrinthitis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
West Nile Viral Infection
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Wound Infection
|
0.04%
3/7111
|
0.07%
5/7125
|
|
Infections and infestations
Wound Sepsis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Alcohol Poisoning
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.07%
5/7111
|
0.08%
6/7125
|
|
Injury, poisoning and procedural complications
Avulsion Fracture
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Injury, poisoning and procedural complications
Back Injury
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Brain Contusion
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Burns Third Degree
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Carbon Monoxide Poisoning
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Cardiac Valve Rupture
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Injury, poisoning and procedural complications
Chest Injury
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Injury, poisoning and procedural complications
Compression Fracture
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Injury, poisoning and procedural complications
Concussion
|
0.03%
2/7111
|
0.08%
6/7125
|
|
Injury, poisoning and procedural complications
Contusion
|
0.06%
4/7111
|
0.08%
6/7125
|
|
Injury, poisoning and procedural complications
Drug Toxicity
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Extradural Haematoma
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Face Injury
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Fall
|
0.21%
15/7111
|
0.15%
11/7125
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.14%
10/7111
|
0.21%
15/7125
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.14%
10/7111
|
0.20%
14/7125
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Gun Shot Wound
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.11%
8/7111
|
0.08%
6/7125
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.21%
15/7111
|
0.22%
16/7125
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.10%
7/7111
|
0.07%
5/7125
|
|
Injury, poisoning and procedural complications
In-Stent Coronary Artery Restenosis
|
0.01%
1/7111
|
0.04%
3/7125
|
|
Injury, poisoning and procedural complications
Incision Site Haemorrhage
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Injury, poisoning and procedural complications
Injury
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.07%
5/7111
|
0.03%
2/7125
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/7111
|
0.04%
3/7125
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Injury, poisoning and procedural complications
Meniscus Lesion
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Injury, poisoning and procedural complications
Multiple Fractures
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Multiple Injuries
|
0.04%
3/7111
|
0.00%
0/7125
|
|
Injury, poisoning and procedural complications
Muscle Rupture
|
0.01%
1/7111
|
0.04%
3/7125
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Neck Injury
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Injury, poisoning and procedural complications
Operative Haemorrhage
|
0.01%
1/7111
|
0.13%
9/7125
|
|
Injury, poisoning and procedural complications
Overdose
|
0.06%
4/7111
|
0.00%
0/7125
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.04%
3/7111
|
0.04%
3/7125
|
|
Injury, poisoning and procedural complications
Periorbital Haematoma
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.15%
11/7111
|
0.14%
10/7125
|
|
Injury, poisoning and procedural complications
Postoperative Respiratory Distress
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Postoperative Wound Complication
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Procedural Complication
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Injury, poisoning and procedural complications
Pubis Fracture
|
0.00%
0/7111
|
0.06%
4/7125
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.04%
3/7111
|
0.03%
2/7125
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.08%
6/7111
|
0.17%
12/7125
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Seroma
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Injury, poisoning and procedural complications
Skeletal Injury
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Injury, poisoning and procedural complications
Skin Injury
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.01%
1/7111
|
0.06%
4/7125
|
|
Injury, poisoning and procedural complications
Skull Fractured Base
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Soft Tissue Injury
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Spinal Column Injury
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.04%
3/7111
|
0.08%
6/7125
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Injury, poisoning and procedural complications
Splenic Rupture
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Injury, poisoning and procedural complications
Subcutaneous Haematoma
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.21%
15/7111
|
0.22%
16/7125
|
|
Injury, poisoning and procedural complications
Subdural Haemorrhage
|
0.03%
2/7111
|
0.08%
6/7125
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Injury, poisoning and procedural complications
Therapeutic Agent Toxicity
|
0.11%
8/7111
|
0.06%
4/7125
|
|
Injury, poisoning and procedural complications
Thoracic Vertebral Fracture
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/7111
|
0.06%
4/7125
|
|
Injury, poisoning and procedural complications
Traumatic Brain Injury
|
0.04%
3/7111
|
0.04%
3/7125
|
|
Injury, poisoning and procedural complications
Traumatic Fracture
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Injury, poisoning and procedural complications
Traumatic Haematoma
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Injury, poisoning and procedural complications
Traumatic Haemorrhage
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Injury, poisoning and procedural complications
Traumatic Intracranial Haemorrhage
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.04%
3/7111
|
0.07%
5/7125
|
|
Injury, poisoning and procedural complications
Vascular Graft Occlusion
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Injury, poisoning and procedural complications
Wound Haemorrhage
|
0.04%
3/7111
|
0.08%
6/7125
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Investigations
Alanine Aminotransferase Increased
|
0.10%
7/7111
|
0.03%
2/7125
|
|
Investigations
Arteriogram
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Investigations
Arteriogram Coronary
|
0.00%
0/7111
|
0.04%
3/7125
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.07%
5/7111
|
0.01%
1/7125
|
|
Investigations
Bilirubin Conjugated Increased
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Investigations
Blood Amylase Increased
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Investigations
Blood Bilirubin Increased
|
0.06%
4/7111
|
0.01%
1/7125
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Investigations
Blood Glucose Increased
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Investigations
Blood Potassium Decreased
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Investigations
Blood Pressure Increased
|
0.03%
2/7111
|
0.06%
4/7125
|
|
Investigations
C-Reactive Protein Increased
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Investigations
Chest X-Ray Abnormal
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Investigations
Coagulation Time Prolonged
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Investigations
Dexamethasone Suppression Test Positive
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Investigations
Ejection Fraction Decreased
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Investigations
Haemoglobin Decreased
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Investigations
Heart Rate Decreased
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Investigations
Heart Rate Increased
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Investigations
Heart Rate Irregular
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Investigations
Hepatic Enzyme Abnormal
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Investigations
Hepatic Enzyme Increased
|
0.11%
8/7111
|
0.18%
13/7125
|
|
Investigations
International Normalised Ratio Abnormal
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Investigations
International Normalised Ratio Increased
|
0.23%
16/7111
|
0.32%
23/7125
|
|
Investigations
Intraocular Pressure Increased
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Investigations
Laboratory Test Interference
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Investigations
Lipase Increased
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Investigations
Liver Function Test Abnormal
|
0.14%
10/7111
|
0.20%
14/7125
|
|
Investigations
Occult Blood
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Investigations
Occult Blood Positive
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Investigations
Pancreatic Enzymes Increased
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Investigations
Transaminases Increased
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Investigations
Weight Decreased
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Metabolism and nutrition disorders
Cachexia
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Metabolism and nutrition disorders
Dehydration
|
0.25%
18/7111
|
0.22%
16/7125
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.45%
32/7111
|
0.32%
23/7125
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.13%
9/7111
|
0.11%
8/7125
|
|
Metabolism and nutrition disorders
Diabetic Foot
|
0.07%
5/7111
|
0.06%
4/7125
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Metabolism and nutrition disorders
Gout
|
0.08%
6/7111
|
0.06%
4/7125
|
|
Metabolism and nutrition disorders
Haemochromatosis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.14%
10/7111
|
0.10%
7/7125
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.03%
2/7111
|
0.04%
3/7125
|
|
Metabolism and nutrition disorders
Hyperosmolar State
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.27%
19/7111
|
0.20%
14/7125
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.07%
5/7111
|
0.11%
8/7125
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.07%
5/7111
|
0.08%
6/7125
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/7111
|
0.04%
3/7125
|
|
Metabolism and nutrition disorders
Neuroglycopenia
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Metabolism and nutrition disorders
Podagra
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Metabolism and nutrition disorders
Shock Hypoglycaemic
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Metabolism and nutrition disorders
Type 1 Diabetes Mellitus
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.08%
6/7111
|
0.07%
5/7125
|
|
Metabolism and nutrition disorders
Vitamin B12 Deficiency
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.08%
6/7111
|
0.07%
5/7125
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.06%
4/7111
|
0.04%
3/7125
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.21%
15/7111
|
0.18%
13/7125
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Compartment Syndrome
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.01%
1/7111
|
0.04%
3/7125
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's Contracture
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Musculoskeletal and connective tissue disorders
Fracture Nonunion
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Musculoskeletal and connective tissue disorders
Gouty Arthritis
|
0.04%
3/7111
|
0.06%
4/7125
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.13%
9/7111
|
0.14%
10/7125
|
|
Musculoskeletal and connective tissue disorders
Inguinal Mass
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Disorder
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.07%
5/7111
|
0.06%
4/7125
|
|
Musculoskeletal and connective tissue disorders
Jaw Cyst
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Joint Range of Motion Decreased
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Musculoskeletal and connective tissue disorders
Knee Deformity
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Musculoskeletal and connective tissue disorders
Mobility Decreased
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Muscle Atrophy
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Muscle Haemorrhage
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.13%
9/7111
|
0.07%
5/7125
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.04%
3/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.06%
4/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Neuropathic Arthropathy
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.41%
29/7111
|
0.67%
48/7125
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Musculoskeletal and connective tissue disorders
Periostitis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/7111
|
0.06%
4/7125
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia Rheumatica
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Musculoskeletal and connective tissue disorders
Psoriatic Arthropathy
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Musculoskeletal and connective tissue disorders
Soft Tissue Haemorrhage
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.04%
3/7111
|
0.04%
3/7125
|
|
Musculoskeletal and connective tissue disorders
Spinal Disorder
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.06%
4/7111
|
0.07%
5/7125
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Musculoskeletal and connective tissue disorders
Sympathetic Posterior Cervical Syndrome
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Synovial Cyst
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Musculoskeletal and connective tissue disorders
Systemic Lupus Erythematosus
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.04%
3/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal Adenoma
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-Cell Lymphoma
|
0.01%
1/7111
|
0.04%
3/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.07%
5/7111
|
0.11%
8/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Colonic Neoplasm
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm of Bladder
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm of Prostate
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile Duct Cancer
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.03%
2/7111
|
0.06%
4/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Neoplasm
|
0.08%
6/7111
|
0.07%
5/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Papilloma
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carcinoma
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone Sarcoma
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's Disease
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Cancer Metastatic
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm Benign
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.18%
13/7111
|
0.21%
15/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Metastatic
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer in Situ
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Neoplasm
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial Carcinoma
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix Carcinoma
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Adenoma
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.30%
21/7111
|
0.20%
14/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Metastatic
|
0.04%
3/7111
|
0.11%
8/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Recurrent
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Stage Iii
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Neoplasm
|
0.04%
3/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal Cancer
|
0.00%
0/7111
|
0.07%
5/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Cancer
|
0.10%
7/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Cancer Metastatic
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epiglottic Carcinoma
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder Cancer
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.10%
7/7111
|
0.08%
6/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer Stage I
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer Stage Iv
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Carcinoma
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma Multiforme
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Adenoma
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Cancer Metastatic
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm Malignant
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected Neoplasm
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intra-Abdominal Haemangioma
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial Tumour Haemorrhage
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large Cell Carcinoma of the Respiratory Tract Stage Unspecified
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal Cancer
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma Recurrent
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo Maligna Stage Unspecified
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip And/Or Oral Cavity Cancer
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.03%
2/7111
|
0.04%
3/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma Metastatic
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer Metastatic
|
0.04%
3/7111
|
0.03%
2/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Carcinoma Cell Type Unspecified Stage Iv
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm
|
0.04%
3/7111
|
0.06%
4/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.15%
11/7111
|
0.14%
10/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Squamous Cell Carcinoma Stage Unspecified
|
0.04%
3/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.03%
2/7111
|
0.06%
4/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.07%
5/7111
|
0.10%
7/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Palate Neoplasm
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Urinary Tract Neoplasm
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma Malignant
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Central Nervous System
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Liver
|
0.07%
5/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Lung
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Bronchial Carcinoma
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Carcinoma of the Bladder
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Malignant Melanoma
|
0.03%
2/7111
|
0.04%
3/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Neoplasm
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple Myeloma
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative Disorder
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Malignant
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Prostate
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurilemmoma Malignant
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine Carcinoma of the Skin
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's Lymphoma
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's Lymphoma Recurrent
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Small Cell Lung Cancer
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Adenocarcinoma
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Carcinoma
|
0.03%
2/7111
|
0.04%
3/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Fibroma
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Neoplasm
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.04%
3/7111
|
0.06%
4/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma Metastatic
|
0.04%
3/7111
|
0.03%
2/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Neoplasm
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic Syndrome
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary Tumour Benign
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia Vera
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.21%
15/7111
|
0.22%
16/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer Metastatic
|
0.04%
3/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer Recurrent
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic Adenoma
|
0.11%
8/7111
|
0.04%
3/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.04%
3/7111
|
0.06%
4/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Neoplasm
|
0.04%
3/7111
|
0.03%
2/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer
|
0.03%
2/7111
|
0.06%
4/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.03%
2/7111
|
0.04%
3/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Neoplasm
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary Gland Cancer
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary Gland Neoplasm
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Cancer
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Lung Cancer Stage Unspecified
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Intestine Carcinoma
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.07%
5/7111
|
0.07%
5/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Skin
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis Cancer
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat Cancer
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Adenoma
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Cancer
|
0.03%
2/7111
|
0.04%
3/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Neoplasm
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric Cancer
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric Cancer Metastatic
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Cancer
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval Cancer
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Anoxic Encephalopathy
|
0.01%
1/7111
|
0.04%
3/7125
|
|
Nervous system disorders
Aphasia
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Balance Disorder
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Nervous system disorders
Basal Ganglia Haemorrhage
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Brachial Plexopathy
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Brain Oedema
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Brain Stem Infarction
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Carotid Arteriosclerosis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Carotid Artery Disease
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Carotid Artery Occlusion
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.07%
5/7111
|
0.08%
6/7125
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Cauda Equina Syndrome
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Central Pain Syndrome
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Cerebellar Haemorrhage
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Nervous system disorders
Cerebral Arteriosclerosis
|
0.04%
3/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Cerebral Haematoma
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.10%
7/7111
|
0.13%
9/7125
|
|
Nervous system disorders
Cerebral Infarction
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.20%
14/7111
|
0.11%
8/7125
|
|
Nervous system disorders
Cerebrovascular Disorder
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Cerebrovascular Insufficiency
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Cervicobrachial Syndrome
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Chorea
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Clonic Convulsion
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Cognitive Disorder
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Coma
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Complex Partial Seizures
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Convulsion
|
0.15%
11/7111
|
0.17%
12/7125
|
|
Nervous system disorders
Dementia
|
0.04%
3/7111
|
0.07%
5/7125
|
|
Nervous system disorders
Dementia Alzheimer's Type
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Diabetic Autonomic Neuropathy
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Diabetic Neuropathy
|
0.04%
3/7111
|
0.13%
9/7125
|
|
Nervous system disorders
Dizziness
|
0.06%
4/7111
|
0.06%
4/7125
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Dyskinesia
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Encephalopathy
|
0.04%
3/7111
|
0.04%
3/7125
|
|
Nervous system disorders
Epilepsy
|
0.15%
11/7111
|
0.17%
12/7125
|
|
Nervous system disorders
Facial Palsy
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Facial Paresis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Grand Mal Convulsion
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.18%
13/7111
|
0.48%
34/7125
|
|
Nervous system disorders
Haemorrhagic Cerebral Infarction
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.23%
16/7111
|
0.20%
14/7125
|
|
Nervous system disorders
Haemorrhagic Transformation Stroke
|
0.08%
6/7111
|
0.15%
11/7125
|
|
Nervous system disorders
Headache
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Nervous system disorders
Hemiparesis
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Hepatic Encephalopathy
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Hypertensive Encephalopathy
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Hypoglycaemic Coma
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Hypotonia
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Hypoxic Encephalopathy
|
0.00%
0/7111
|
0.04%
3/7125
|
|
Nervous system disorders
Iiird Nerve Paralysis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Intercostal Neuralgia
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Nervous system disorders
Intracranial Aneurysm
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Intracranial Haematoma
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Nervous system disorders
Intraventricular Haemorrhage
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Ischaemic Neuropathy
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Ischaemic Stroke
|
0.25%
18/7111
|
0.36%
26/7125
|
|
Nervous system disorders
Lacunar Infarction
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Loss of Consciousness
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Lumbar Radiculopathy
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Metabolic Encephalopathy
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Migraine
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Myasthenia Gravis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Nerve Compression
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Neuritis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.03%
2/7111
|
0.04%
3/7125
|
|
Nervous system disorders
Paraesthesia
|
0.04%
3/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Parkinson's Disease
|
0.03%
2/7111
|
0.04%
3/7125
|
|
Nervous system disorders
Parkinsonism
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Partial Seizures with Secondary Generalisation
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Petit Mal Epilepsy
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Polyneuropathy
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Postictal Paralysis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Presyncope
|
0.08%
6/7111
|
0.07%
5/7125
|
|
Nervous system disorders
Radicular Syndrome
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Radiculitis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Radiculitis Lumbosacral
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Sciatica
|
0.06%
4/7111
|
0.06%
4/7125
|
|
Nervous system disorders
Senile Dementia
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Sensory Disturbance
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Simple Partial Seizures
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Status Epilepticus
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.06%
4/7111
|
0.07%
5/7125
|
|
Nervous system disorders
Syncope
|
0.77%
55/7111
|
0.59%
42/7125
|
|
Nervous system disorders
Toxic Encephalopathy
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Transient Global Amnesia
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.70%
50/7111
|
1.00%
71/7125
|
|
Nervous system disorders
Vascular Dementia
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Vascular Encephalopathy
|
0.07%
5/7111
|
0.04%
3/7125
|
|
Nervous system disorders
Vertebrobasilar Insufficiency
|
0.08%
6/7111
|
0.06%
4/7125
|
|
Nervous system disorders
Vith Nerve Disorder
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Pregnancy, puerperium and perinatal conditions
Cephalhaematoma
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Psychiatric disorders
Acute Psychosis
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Psychiatric disorders
Agitation
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Psychiatric disorders
Alcohol Abuse
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Psychiatric disorders
Anxiety
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Psychiatric disorders
Completed Suicide
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Psychiatric disorders
Confusional State
|
0.06%
4/7111
|
0.07%
5/7125
|
|
Psychiatric disorders
Delirium
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Psychiatric disorders
Delusion
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Psychiatric disorders
Depression
|
0.04%
3/7111
|
0.13%
9/7125
|
|
Psychiatric disorders
Disorientation
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Psychiatric disorders
Generalised Anxiety Disorder
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Psychiatric disorders
Hallucination, Visual
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Psychiatric disorders
Mental Disorder Due to A General Medical Condition
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Psychiatric disorders
Mental Status Changes
|
0.04%
3/7111
|
0.06%
4/7125
|
|
Psychiatric disorders
Mood Disorder Due to A General Medical Condition
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Psychiatric disorders
Neurosis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Psychiatric disorders
Panic Disorder
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Psychiatric disorders
Post-Traumatic Stress Disorder
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Psychiatric disorders
Psychotic Disorder
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Psychiatric disorders
Schizophrenia
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Psychiatric disorders
Suicide Attempt
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Renal and urinary disorders
Acute Prerenal Failure
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Renal and urinary disorders
Bladder Neck Obstruction
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Renal and urinary disorders
Bladder Prolapse
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Renal and urinary disorders
Calculus Bladder
|
0.06%
4/7111
|
0.01%
1/7125
|
|
Renal and urinary disorders
Calculus Ureteric
|
0.03%
2/7111
|
0.04%
3/7125
|
|
Renal and urinary disorders
Calculus Urethral
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Renal and urinary disorders
Calculus Urinary
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Renal and urinary disorders
Cystitis Erosive
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Renal and urinary disorders
Cystitis Haemorrhagic
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Renal and urinary disorders
Focal Segmental Glomerulosclerosis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Renal and urinary disorders
Haematuria
|
0.87%
62/7111
|
0.65%
46/7125
|
|
Renal and urinary disorders
Haemorrhage Urinary Tract
|
0.04%
3/7111
|
0.01%
1/7125
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Renal and urinary disorders
Hypertensive Nephropathy
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Renal and urinary disorders
Kidney Enlargement
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.13%
9/7111
|
0.13%
9/7125
|
|
Renal and urinary disorders
Nephropathy
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Renal and urinary disorders
Nephropathy Toxic
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Renal and urinary disorders
Nephrotic Syndrome
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Renal and urinary disorders
Obstructive Uropathy
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Renal and urinary disorders
Renal Artery Arteriosclerosis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Renal and urinary disorders
Renal Colic
|
0.01%
1/7111
|
0.04%
3/7125
|
|
Renal and urinary disorders
Renal Cyst
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Renal and urinary disorders
Renal Failure
|
0.38%
27/7111
|
0.25%
18/7125
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.52%
37/7111
|
0.65%
46/7125
|
|
Renal and urinary disorders
Renal Failure Chronic
|
0.13%
9/7111
|
0.11%
8/7125
|
|
Renal and urinary disorders
Renal Haemorrhage
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Renal and urinary disorders
Renal Impairment
|
0.07%
5/7111
|
0.11%
8/7125
|
|
Renal and urinary disorders
Ureteric Haemorrhage
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Renal and urinary disorders
Urethral Haemorrhage
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Renal and urinary disorders
Urethral Stenosis
|
0.07%
5/7111
|
0.03%
2/7125
|
|
Renal and urinary disorders
Urinary Bladder Haemorrhage
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Renal and urinary disorders
Urinary Bladder Polyp
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Renal and urinary disorders
Urinary Retention
|
0.17%
12/7111
|
0.10%
7/7125
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Renal and urinary disorders
Urogenital Haemorrhage
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.21%
15/7111
|
0.21%
15/7125
|
|
Reproductive system and breast disorders
Endometrial Hyperplasia
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Reproductive system and breast disorders
Endometrial Hypertrophy
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Reproductive system and breast disorders
Epididymitis
|
0.04%
3/7111
|
0.01%
1/7125
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Reproductive system and breast disorders
Female Genital Tract Fistula
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Reproductive system and breast disorders
Genital Haemorrhage
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Reproductive system and breast disorders
Haemorrhagic Ovarian Cyst
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.06%
4/7111
|
0.04%
3/7125
|
|
Reproductive system and breast disorders
Oedema Genital
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Reproductive system and breast disorders
Postmenopausal Haemorrhage
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Reproductive system and breast disorders
Prostatic Obstruction
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Reproductive system and breast disorders
Prostatitis
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Reproductive system and breast disorders
Scrotal Oedema
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Reproductive system and breast disorders
Uterine Haemorrhage
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Reproductive system and breast disorders
Uterine Polyp
|
0.06%
4/7111
|
0.03%
2/7125
|
|
Reproductive system and breast disorders
Uterine Prolapse
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.08%
6/7111
|
0.03%
2/7125
|
|
Reproductive system and breast disorders
Vulval Ulceration
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.18%
13/7111
|
0.13%
9/7125
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.10%
7/7111
|
0.13%
9/7125
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.08%
6/7111
|
0.15%
11/7125
|
|
Respiratory, thoracic and mediastinal disorders
Brain Hypoxia
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
|
0.14%
10/7111
|
0.13%
9/7125
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.83%
59/7111
|
0.79%
56/7125
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Respiratory Failure
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic Hernia
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.13%
9/7111
|
0.35%
25/7125
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.55%
39/7111
|
0.58%
41/7125
|
|
Respiratory, thoracic and mediastinal disorders
Foreign Body Aspiration
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.14%
10/7111
|
0.13%
9/7125
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.06%
4/7111
|
0.04%
3/7125
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.07%
5/7111
|
0.03%
2/7125
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Polyp
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.04%
3/7111
|
0.03%
2/7125
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal Haematoma
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Polyps
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Septum Deviation
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal Cyst
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Oedema
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.23%
16/7111
|
0.17%
12/7125
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.06%
4/7111
|
0.04%
3/7125
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.07%
5/7111
|
0.03%
2/7125
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.04%
3/7111
|
0.01%
1/7125
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Amyloidosis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Arterial Hypertension
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.21%
15/7111
|
0.25%
18/7125
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
|
0.04%
3/7111
|
0.01%
1/7125
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.04%
3/7111
|
0.04%
3/7125
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Microemboli
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.21%
15/7111
|
0.10%
7/7125
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.25%
18/7111
|
0.25%
18/7125
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Respiratory, thoracic and mediastinal disorders
Status Asthmaticus
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Skin and subcutaneous tissue disorders
Blood Blister
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Skin and subcutaneous tissue disorders
Dermal Cyst
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Skin and subcutaneous tissue disorders
Dry Gangrene
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.06%
4/7111
|
0.07%
5/7125
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic Vasculitis
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic Dermatitis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Skin and subcutaneous tissue disorders
Skin Disorder
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Skin and subcutaneous tissue disorders
Skin Haemorrhage
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.07%
5/7111
|
0.11%
8/7125
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer Haemorrhage
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson Syndrome
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Skin and subcutaneous tissue disorders
Umbilical Haemorrhage
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Skin and subcutaneous tissue disorders
Urticaria Chronic
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Surgical and medical procedures
Cardiac Pacemaker Battery Replacement
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Surgical and medical procedures
Cardiac Pacemaker Insertion
|
0.04%
3/7111
|
0.01%
1/7125
|
|
Surgical and medical procedures
Cardiac Pacemaker Replacement
|
0.04%
3/7111
|
0.03%
2/7125
|
|
Surgical and medical procedures
Cardiac Pacemaker Revision
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Surgical and medical procedures
Cardioversion
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Surgical and medical procedures
Carpal Tunnel Decompression
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Surgical and medical procedures
Cataract Operation
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Surgical and medical procedures
Finger Amputation
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Surgical and medical procedures
Foot Amputation
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Surgical and medical procedures
Haemorrhoid Operation
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Surgical and medical procedures
Hip Arthroplasty
|
0.04%
3/7111
|
0.01%
1/7125
|
|
Surgical and medical procedures
Implantable Defibrillator Insertion
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Surgical and medical procedures
Inguinal Hernia Repair
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Surgical and medical procedures
Knee Arthroplasty
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Surgical and medical procedures
Knee Operation
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Surgical and medical procedures
Limb Operation
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Surgical and medical procedures
Penile Repair
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Surgical and medical procedures
Percutaneous Coronary Intervention
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Surgical and medical procedures
Polypectomy
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Surgical and medical procedures
Prostatectomy
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Surgical and medical procedures
Skin Graft
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Surgical and medical procedures
Skin Neoplasm Excision
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Surgical and medical procedures
Tooth Extraction
|
0.04%
3/7111
|
0.01%
1/7125
|
|
Surgical and medical procedures
Transurethral Prostatectomy
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Surgical and medical procedures
Varicose Vein Operation
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Surgical and medical procedures
Wound Drainage
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Vascular disorders
Accelerated Hypertension
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Vascular disorders
Angiopathy
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Vascular disorders
Aortic Aneurysm
|
0.08%
6/7111
|
0.10%
7/7125
|
|
Vascular disorders
Aortic Aneurysm Rupture
|
0.03%
2/7111
|
0.08%
6/7125
|
|
Vascular disorders
Aortic Dilatation
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Vascular disorders
Aortic Disorder
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Vascular disorders
Aortic Dissection
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Vascular disorders
Aortic Stenosis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Vascular disorders
Arterial Occlusive Disease
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Vascular disorders
Arterial Stenosis Limb
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Vascular disorders
Arterial Thrombosis Limb
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Vascular disorders
Arteriosclerosis
|
0.03%
2/7111
|
0.03%
2/7125
|
|
Vascular disorders
Arteriosclerosis Obliterans
|
0.06%
4/7111
|
0.04%
3/7125
|
|
Vascular disorders
Arteriovenous Fistula
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Vascular disorders
Bleeding Varicose Vein
|
0.06%
4/7111
|
0.01%
1/7125
|
|
Vascular disorders
Circulatory Collapse
|
0.04%
3/7111
|
0.01%
1/7125
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.17%
12/7111
|
0.21%
15/7125
|
|
Vascular disorders
Diabetic Vascular Disorder
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Vascular disorders
Diastolic Hypertension
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Vascular disorders
Essential Hypertension
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Vascular disorders
Extremity Necrosis
|
0.03%
2/7111
|
0.01%
1/7125
|
|
Vascular disorders
Femoral Arterial Stenosis
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Vascular disorders
Femoral Artery Occlusion
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Vascular disorders
Haematoma
|
0.45%
32/7111
|
0.59%
42/7125
|
|
Vascular disorders
Haemodynamic Instability
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Vascular disorders
Haemorrhage
|
0.01%
1/7111
|
0.07%
5/7125
|
|
Vascular disorders
Haemorrhagic Infarction
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Vascular disorders
Hypertension
|
0.37%
26/7111
|
0.39%
28/7125
|
|
Vascular disorders
Hypertensive Crisis
|
0.23%
16/7111
|
0.22%
16/7125
|
|
Vascular disorders
Hypertensive Emergency
|
0.01%
1/7111
|
0.03%
2/7125
|
|
Vascular disorders
Hypotension
|
0.18%
13/7111
|
0.21%
15/7125
|
|
Vascular disorders
Hypovolaemic Shock
|
0.06%
4/7111
|
0.03%
2/7125
|
|
Vascular disorders
Intermittent Claudication
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Vascular disorders
Jugular Vein Distension
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Vascular disorders
Lymphoedema
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Vascular disorders
Microangiopathy
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Vascular disorders
Orthostatic Hypotension
|
0.06%
4/7111
|
0.11%
8/7125
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.11%
8/7111
|
0.11%
8/7125
|
|
Vascular disorders
Peripheral Ischaemia
|
0.14%
10/7111
|
0.03%
2/7125
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.10%
7/7111
|
0.04%
3/7125
|
|
Vascular disorders
Phlebitis
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Vascular disorders
Raynaud's Phenomenon
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Vascular disorders
Shock Haemorrhagic
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Vascular disorders
Thrombophlebitis Migrans
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.00%
0/7111
|
0.04%
3/7125
|
|
Vascular disorders
Varicose Ulceration
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Vascular disorders
Varicose Vein
|
0.04%
3/7111
|
0.03%
2/7125
|
|
Vascular disorders
Vasculitis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Vascular disorders
Vasculitis Necrotising
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Vascular disorders
Venous Insufficiency
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Vascular disorders
Venous Thrombosis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Vascular disorders
Venous Thrombosis Limb
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Blood and lymphatic system disorders
Anaemia Macrocytic
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
0.00%
0/7111
|
0.03%
2/7125
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Blood and lymphatic system disorders
Splenic Haemorrhage
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Cardiac disorders
Chronotropic Incompetence
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Cardiac disorders
Mitral Valve Disease
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Cardiac disorders
Mitral Valve Stenosis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Cardiac disorders
Tricuspid Valve Incompetence
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Ear and labyrinth disorders
External Ear Disorder
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Anal Fissure
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Barrett's Oesophagus
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Erosive Oesophagitis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Gastrointestinal disorders
Pancreatitis Chronic
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Peritoneal Haemorrhage
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Gastrointestinal disorders
Small Intestinal Perforation
|
0.00%
0/7111
|
0.01%
1/7125
|
|
General disorders
Feeling Abnormal
|
0.00%
0/7111
|
0.01%
1/7125
|
|
General disorders
Implant Site Effusion
|
0.01%
1/7111
|
0.00%
0/7125
|
|
General disorders
Mucosal Inflammation
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Hepatobiliary disorders
Acute Hepatic Failure
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Hepatobiliary disorders
Haemorrhagic Hepatic Cyst
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Febrile Infection
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Haemophilus Infection
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Necrotising Fasciitis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Neutropenic Sepsis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Pharyngeal Abscess
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Pseudomembranous Colitis
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Infections and infestations
Respiratory Tract Infection Bacterial
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Infections and infestations
Sepsis Syndrome
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Cardiac Function Disturbance Postoperative
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Injury, poisoning and procedural complications
Eschar
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Injury, poisoning and procedural complications
Foreign Body
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Nerve Injury
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Traumatic Lung Injury
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Injury, poisoning and procedural complications
Venous Injury
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Investigations
Aspiration Bronchial
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Investigations
Prothrombin Level Decreased
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Investigations
Prothrombin Time Prolonged
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Metabolism and nutrition disorders
Failure to Thrive
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Musculoskeletal and connective tissue disorders
Trigger Finger
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Pancreas
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Soft Tissue Neoplasm
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Stage I
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Stage Iv
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Neoplasm
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Neoplasm
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Stromal Tumour
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis Carcinomatosa
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mediastinum Neoplasm
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Bone
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Skin
|
0.01%
1/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Neoplasm
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Squamous Cell Carcinoma
|
0.03%
2/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer Stage Iii
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Refractory Anaemia with An Excess of Blasts
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal Cancer
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteral Neoplasm
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Cerebellar Atrophy
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Diabetic Hyperosmolar Coma
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Nervous system disorders
Embolic Stroke
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Hydrocephalus
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Myoclonus
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Nervous system disorders
Paraplegia
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Psychiatric disorders
Bipolar Disorder
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Reproductive system and breast disorders
Fibrocystic Breast Disease
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Reproductive system and breast disorders
Prostatic Atrophy
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Reproductive system and breast disorders
Prostatic Intraepithelial Neoplasia
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Haemorrhage
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Surgical and medical procedures
Abdominal Hernia Repair
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Surgical and medical procedures
Colostomy Closure
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Surgical and medical procedures
Ileostomy
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Surgical and medical procedures
Malignant Tumour Excision
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Vascular disorders
Lymphatic Fistula
|
0.01%
1/7111
|
0.00%
0/7125
|
|
Vascular disorders
Subclavian Vein Thrombosis
|
0.00%
0/7111
|
0.01%
1/7125
|
|
Vascular disorders
Vena Cava Thrombosis
|
0.00%
0/7111
|
0.01%
1/7125
|
Other adverse events
| Measure |
Rivaroxaban
n=7111 participants at risk
Rivaroxaban 15 mg p.o. once daily or Rivaroxaban 20 mg p.o. once daily
|
Warfarin
n=7125 participants at risk
Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
384/7111
|
5.6%
401/7125
|
|
General disorders
Oedema Peripheral
|
6.2%
443/7111
|
6.3%
451/7125
|
|
Infections and infestations
Bronchitis
|
5.3%
377/7111
|
5.6%
401/7125
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
430/7111
|
6.5%
464/7125
|
|
Nervous system disorders
Dizziness
|
6.3%
445/7111
|
6.4%
453/7125
|
|
Nervous system disorders
Headache
|
4.7%
332/7111
|
5.2%
367/7125
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.5%
389/7111
|
5.4%
382/7125
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.9%
705/7111
|
8.3%
594/7125
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
356/7111
|
5.1%
363/7125
|
Additional Information
Head of Development, CV & UROL
Johnson & Johnson Pharmaceutical Research & Development L.L.C.
Phone: 1 908-927-7767
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60